{"id":"cantharidin","rwe":[{"pmid":"41812835","year":"2026","title":"Cancer cell membrane and iRGD peptide co-modified cantharidin liposomes for targeted therapy and immunotherapy of triple-negative breast cancer.","finding":"","journal":"Free radical biology & medicine","studyType":"Clinical Study"},{"pmid":"41790122","year":"2026","title":"Compounds Identified by Screening that Inhibit the Activity of Transcription Factor FOXO1/3a Suppress Dexamethasone-Induced Atrogin1 Expression in C2C12 Myoblasts.","finding":"","journal":"Bioscience, biotechnology, and biochemistry","studyType":"Clinical Study"},{"pmid":"41707298","year":"2026","title":"MdPP2AC interacting with MdCLC to mediate ALA-induced salt tolerance in apple.","finding":"","journal":"Plant physiology and biochemistry : PPB","studyType":"Clinical Study"},{"pmid":"41589402","year":"2026","title":"Cantharidic acid causes mitochondrial dysfunction via the Nrf2/HO-1/GPX4 pathway to inhibit colorectal cancer progression.","finding":"","journal":"Histology and histopathology","studyType":"Clinical Study"},{"pmid":"41554212","year":"2026","title":"Discovery, crystal structure, anticancer property of the first-row transition metal complexes of norcantharidin (NCTD) as potential inducer of mitochondrial damage.","finding":"","journal":"Journal of inorganic biochemistry","studyType":"Clinical Study"}],"_fda":{"id":"74b0c983-fd38-49b0-a9a6-cb4e7dd777b5","set_id":"7c9bdeaa-9822-4c69-a719-ea4a8643f59c","openfda":{"unii":["IGL471WQ8P"],"route":["TOPICAL"],"rxcui":["244521","2643442"],"spl_id":["74b0c983-fd38-49b0-a9a6-cb4e7dd777b5"],"brand_name":["YCANTH"],"spl_set_id":["7c9bdeaa-9822-4c69-a719-ea4a8643f59c"],"package_ndc":["71349-070-01","71349-070-12","71349-070-11","71349-070-06","71349-999-01","71349-999-06"],"product_ndc":["71349-070","71349-999"],"generic_name":["CANTHARIDIN"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["CANTHARIDIN"],"manufacturer_name":["Verrica Pharmaceuticals Inc."],"application_number":["NDA212905"],"is_original_packager":[true]},"version":"4","pregnancy":["8.1 Pregnancy Risk Summary There are no available data with use of YCANTH in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies were not conducted with cantharidin. Given that systemic exposure to cantharidin following topical administration is low, maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology (12.3) ]. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively."],"overdosage":["10 OVERDOSAGE Oral ingestion of cantharidin has resulted in renal failure, blistering and severe damage to the gastrointestinal tract, coagulopathy, seizures, and flaccid paralysis. In the event that YCANTH topical solution is ingested, patients should seek medical attention immediately and contact a Poison Control Center (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations."],"description":["11 DESCRIPTION YCANTH (cantharidin) topical solution is a light violet to dark purple, slightly viscous liquid for topical administration. Each mL of YCANTH topical solution contains 7 mg of active ingredient cantharidin (0.7%), a lipophilic compound. Cantharidin is a white to off-white solid at room temperature and is only very slightly soluble in water. The chemical name for cantharidin is 1,2-dimethyl-3,6-epoxyperhydrophthalic anhydride. The molecular weight is 196.20 g/mol and the molecular formula is C 10 H 12 O 4 . The structural formula for cantharidin is represented below: The inactive ingredients of YCANTH topical solution are acetone, camphor, castor oil, denatonium benzoate, ethanol (32%), gentian violet, hydroxypropyl cellulose, and nitrocellulose. The inactive ingredient denatonium benzoate is an oral deterrent to help mitigate the risk of accidental ingestion. Chemical Structure"],"how_supplied":["16 HOW SUPPLIED/ STORAGE AND HANDLING 16.1 How Supplied YCANTH topical solution is supplied in a sealed glass ampule contained within a single-use applicator and enclosed in a protective paperboard sleeve. Each ampule of YCANTH contains approximately 0.45 mL of 0.7% cantharidin solution. Each mL of YCANTH contains 7 mg cantharidin (0.7%). A YCANTH Break Tool is co-packaged as 2 units per each 6 count and 12 count carton of applicators and 1 unit per each 1 count carton with 1 applicator. A listing of the available carton packages is provided in Table 3. Table 3. Available Carton Configurations for YCANTH Dosage Strength Single-Use Applicator Single Applicator NDC (Each) Number of YCANTH Applicators (Each) per Carton YCANTH Break Tool Part Reference Number Number of YCANTH Break Tools (Each) per Carton NDC 0.7% (7 mg/mL) 1 each 71349-070-01 1 71349-000-01 1 71349-070-11 6 71349-000-01 2 71349-070-06 12 71349-000-01 2 71349-070-12 Individual YCANTH Break Tools are available separately (Part Reference Number 71349-000-01). To request additional YCANTH Break Tools, contact Verrica Pharmaceuticals at 1-973-298-1390. 16.2 Storage and Handling Store at 20°C to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature], protect from light."],"geriatric_use":["8.5 Geriatric Use Risk Summary YCANTH has not been studied in geriatric patients."],"pediatric_use":["8.4 Pediatric Use Risk Summary The safety and effectiveness of YCANTH for the treatment of molluscum contagiosum have been established in pediatric patients aged 2 years and older. The use of YCANTH in pediatric patients is supported by results from adequate and well-controlled trials in patients 2 years of age and older; although the safety and efficacy of drug use for longer than 12 weeks has not been established [see Clinical Studies (14) ]. The safety and efficacy in pediatric patients below the age of 2 years have not been established ."],"effective_time":"20241113","clinical_studies":["14 CLINICAL STUDIES In two double-blind, randomized, placebo-controlled trials (Trial 1 [NCT03377790] and Trial 2 [NCT03377803]), 528 subjects ages 2 years and older with molluscum contagiosum were randomized by household to treatment with either YCANTH or vehicle. Subjects ranged from 2 to 60 years of age, with a median age of 6. 51% of subjects were male and 91% were Caucasian. The baseline lesion count among subjects ranged from 1 to 184, with a mean of 23 and 19 lesions among subjects in Trial 1 and Trial 2, respectively. Subjects' lesions were treated with either YCANTH or vehicle at intervals of approximately 21 days until complete clearance of the lesion or for a maximum of 4 applications (on Days 1, 21, 42, and 63). Study drug solution was applied and left on the lesions for approximately 24 hours before the lesions were washed with soap and water. A healthcare professional who was blinded to the treatment group counted the number of lesions at each visit. The primary efficacy endpoint was the proportion of patients achieving complete clearance of all treated molluscum contagiosum lesions by Day 84. The secondary efficacy endpoints were the proportions of patients achieving complete clearance of all treated molluscum contagiosum lesions at Day 63, Day 42, and Day 21. Table 2 presents the efficacy results for Trial 1 and Trial 2. Table 2. Percentage of Subjects Exhibiting Complete Clearance of Treatable Molluscum Contagiosum Lesions in Trial 1 and Trial 2 (Intent-to-Treat Population) Trial 1 Trial 2 YCANTH N = 160 Vehicle N = 106 Treatment Difference (95% CI) Treatment difference and 95% CI based on Generalized Estimating Equations (GEE) model for logistic regression with an exchangeable working correlation structure, a factor for treatment, and repeated measurements allowed for a household. Subjects with missing data are imputed as non-responders. YCANTH N = 150 Vehicle N = 112 Treatment Difference (95% CI) CI = confidence interval. Day 84 46% 18% 29% (19%, 38%) 54% 13% 40% (30%, 51%) Day 63 32% 17% 15% (4%, 25%) 28% 5% 23% (15%, 32%) Day 42 21% 9% 10% (2%, 19%) 13% 4% 9% (3%, 16%) Day 21 11% 4% 8% (2%, 14%) 5% 2% 3% (-1%, 8%)"],"pharmacodynamics":["12.2 Pharmacodynamics Cantharidin is a vesicant. The pharmacodynamics of cantharidin in the treatment of molluscum contagiosum are unknown."],"pharmacokinetics":["12.3 Pharmacokinetics Pharmacokinetics of cantharidin were assessed in 16 subjects aged 2 years and older with at least 21 molluscum contagiosum lesions at baseline. Subjects were administered a single, dermal application of cantharidin solution to each lesion. The average number of lesions treated for subjects in the exposure treatment group was 47.4 (median was 35.0). Cantharidin was not detectable in 15 out of 16 subjects. Only one subject had a detectable cantharidin plasma level of 3.391 ng/mL at the 2-hour post-dose. Drug Interaction Studies No studies evaluating the drug interaction potential of cantharidin have been conducted."],"adverse_reactions":["6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Local Skin Reactions [see Warnings and Precautions (5.2) ] Most common (incidence ≥1%) adverse reactions are the following local skin reactions at the application site: vesiculation, pain, pruritus, scabbing, erythema, discoloration, application site dryness, edema, and erosion. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Verrica Pharmaceuticals Inc. at 1-877-837-7422 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Local skin reactions are expected and should be reported if they are severe. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. YCANTH was studied in two randomized, double-blind, placebo-controlled phase 3 trials, Trial 1 (NCT03377790) and Trial 2 (NCT03377803) (n = 266, and n = 262, respectively) in subjects with molluscum contagiosum. Most patients received a single 24-hour dermal administration of YCANTH or vehicle for each lesion every 3 weeks for up to 4 treatments. YCANTH Solution or vehicle were removed prior to the 24-hour timepoint in 109/311 (35%) subjects treated with YCANTH Solution and 46/216 (21%) subjects treated with vehicle due to treatment-emergent adverse events. Table 1 presents the percentage of subjects with selected adverse reactions (incidence ≥ 1%) by the most severe grade reported during Trial 1 and Trial 2. Adverse reactions were primarily local skin reactions at the application site. Local skin reactions at the application site were observed in 97% of subjects treated with YCANTH during both trials. Table 1. Percentage of Subjects with Selected Adverse Reactions (Incidence ≥1%) by Severity in Trial 1 and Trial 2 (Safety Population) YCANTH N=311 Vehicle N=216 Preferred Term Name Mild Moderate Severe Mild Moderate Severe Application site vesicles 60% 32% 4% 27% 2% 0% Application site pain and pain 41% 20% 2% 16% 1% 0% Application site pruritus and pruritus 47% 8% 1% 30% 7% 0% Application site scab and scab 39% 9% 0% 20% 1% 0% Application site erythema and erythema 24% 21% <1% 20% 7% 0% Application site discoloration 28% 4% <1% 12% 1% 0% Application site dryness 19% 2% 0% 14% 1% 0% Application site edema 7% 3% 0% 3% 1% 0% Application site erosion 6% 1% 0% 1% 0% 0% Contact dermatitis 0% 1% 0% 0% 0% 0% There were no serious adverse reactions reported in the two controlled trials. The discontinuation rate due to an adverse reaction was 2.3% among subjects treated with YCANTH and 0.5% among subjects treated with vehicle."],"contraindications":["4 CONTRAINDICATIONS None None"],"how_supplied_table":["
Table 3. Available Carton Configurations for YCANTH
Dosage StrengthSingle-Use ApplicatorSingle Applicator NDC (Each)Number of YCANTH Applicators (Each) per CartonYCANTH Break Tool Part Reference NumberNumber of YCANTH Break Tools (Each) per CartonNDC
0.7% (7 mg/mL)1 each71349-070-01171349-000-01171349-070-11
671349-000-01271349-070-06
1271349-000-01271349-070-12
"],"mechanism_of_action":["12.1 Mechanism of Action The mechanism of action of cantharidin in the treatment of molluscum contagiosum is unknown."],"storage_and_handling":["16.2 Storage and Handling Store at 20°C to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature], protect from light."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The mechanism of action of cantharidin in the treatment of molluscum contagiosum is unknown. 12.2 Pharmacodynamics Cantharidin is a vesicant. The pharmacodynamics of cantharidin in the treatment of molluscum contagiosum are unknown. 12.3 Pharmacokinetics Pharmacokinetics of cantharidin were assessed in 16 subjects aged 2 years and older with at least 21 molluscum contagiosum lesions at baseline. Subjects were administered a single, dermal application of cantharidin solution to each lesion. The average number of lesions treated for subjects in the exposure treatment group was 47.4 (median was 35.0). Cantharidin was not detectable in 15 out of 16 subjects. Only one subject had a detectable cantharidin plasma level of 3.391 ng/mL at the 2-hour post-dose. Drug Interaction Studies No studies evaluating the drug interaction potential of cantharidin have been conducted."],"indications_and_usage":["1 INDICATIONS AND USAGE YCANTH is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older. YCANTH is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older. ( 1 )"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Toxicities Associated with Inappropriate Administration: Life threatening or fatal toxicities can occur if administered orally. Avoid contact with the treatment area, including oral contact, after treatment. Ocular toxicity can occur if YCANTH comes in contact with eyes. If YCANTH gets in eyes, flush eyes with water for at least 15 minutes. ( 5.1 ) Local Skin Reactions : Reactions at the application site have included vesiculation, pruritus, pain, discoloration, and erythema. Avoid application near eyes and mucosal tissue, and to healthy skin. If YCANTH contacts any unintended surface, or healthy skin, immediately remove. If severe local skin reactions occur, remove prior to 24 hours after treatment. ( 5.2 ) Flammability : YCANTH is flammable, even after drying. Avoid fire, flame or smoking near lesion(s) during treatment and after application until removed. ( 5.3 ) 5.1 Toxicities Associated with Inappropriate Administration YCANTH is for topical use only. YCANTH is not for oral, mucosal, or ophthalmic use. Life threatening or fatal toxicities can occur if YCANTH is administered orally [see Overdosage (10) ]. Adverse reactions to oral ingestion of cantharidin have included renal failure, blistering and severe damage to the gastrointestinal tract, coagulopathy, seizures, and flaccid paralysis. Advise patients and/or caregivers to avoid oral contact and to avoid touching lesions after YCANTH treatment and to seek medical attention immediately if YCANTH is accidently ingested. Ocular toxicity can occur if YCANTH comes in contact with the eyes. Adverse reactions from contact of YCANTH with the eyes can include corneal necrosis, ocular perforation, and deep ocular injuries. Do not apply YCANTH near or to the eyes. If YCANTH comes in contact with the eyes, flush eyes with water for at least 15 minutes and seek medical attention immediately. 5.2 Local Skin Reactions YCANTH is a vesicant. Local skin reactions at the application site were observed in 97% of subjects treated with YCANTH during clinical trials. Local skin reactions included vesiculation, pruritus, pain, discoloration, and erythema [see Adverse Reactions (6.1) ] . Avoid application near the eyes and mucosal tissues, and to adjacent healthy skin. If YCANTH contacts any unintended surface, including healthy skin, immediately remove by wiping with a cotton swab or gauze . Avoid other topical products (e.g. creams, lotions, or sunscreen) on treated areas until 24 hours after YCANTH treatment or until washing. Application of other topical products could spread YCANTH and cause blistering or other adverse reactions to healthy skin. If severe blistering, severe pain or other severe adverse reactions occur, remove YCANTH prior to the recommended 24 hours after administration by washing with soap and water . 5.3 Flammability YCANTH is a flammable liquid, even after drying. Avoid fire, flame or smoking near lesion(s) during treatment and after application until removed."],"clinical_studies_table":["
Table 2. Percentage of Subjects Exhibiting Complete Clearance of Treatable Molluscum Contagiosum Lesions in Trial 1 and Trial 2 (Intent-to-Treat Population)
Trial 1Trial 2
YCANTH N = 160Vehicle N = 106Treatment Difference (95% CI)Treatment difference and 95% CI based on Generalized Estimating Equations (GEE) model for logistic regression with an exchangeable working correlation structure, a factor for treatment, and repeated measurements allowed for a household. Subjects with missing data are imputed as non-responders.YCANTH N = 150Vehicle N = 112Treatment Difference (95% CI)
CI = confidence interval.
Day 8446%18%29% (19%, 38%)54%13%40% (30%, 51%)
Day 6332%17%15% (4%, 25%)28%5%23% (15%, 32%)
Day 4221%9%10% (2%, 19%)13%4%9% (3%, 16%)
Day 2111%4%8% (2%, 14%)5%2%3% (-1%, 8%)
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been conducted with cantharidin. Cantharidin was not mutagenic in a bacteria reverse mutation (Ames) assay. An in vitro chromosomal aberration assay in human lymphocytes with cantharidin was inconclusive. Cantharidin was positive in an in vitro micronucleus assay in TK6 cells, primarily through an aneugenic mechanism. The effects of cantharidin on fertility have not been evaluated."],"adverse_reactions_table":["
Table 1. Percentage of Subjects with Selected Adverse Reactions (Incidence ≥1%) by Severity in Trial 1 and Trial 2 (Safety Population)
YCANTH N=311Vehicle N=216
Preferred Term NameMildModerateSevereMildModerateSevere
Application site vesicles60%32%4%27%2%0%
Application site pain and pain41%20%2%16%1%0%
Application site pruritus and pruritus47%8%1%30%7%0%
Application site scab and scab39%9%0%20%1%0%
Application site erythema and erythema24%21%<1%20%7%0%
Application site discoloration28%4%<1%12%1%0%
Application site dryness19%2%0%14%1%0%
Application site edema7%3%0%3%1%0%
Application site erosion6%1%0%1%0%0%
Contact dermatitis0%1%0%0%0%0%
"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregivers to read the FDA-approved patient labeling (Patient Information). Toxicities Associated with Inappropriate Administration Inform patients and/or caregivers that YCANTH can be fatal if ingested orally. Instruct patients and/or caregivers to avoid oral contact and to avoid touching lesions after YCANTH treatment. If YCANTH is accidentally ingested, inform patients and/or caregivers to seek medical attention immediately. Advise patients and/or caregivers that severe eye injury can occur if YCANTH gets into the eyes. If YCANTH gets in the eyes, advise patients and/or caregivers to flush eyes with water for at least 15 minutes and seek medical attention immediately [see Warnings and Precautions (5.1) ] . Local Skin Reactions Inform patients and/or caregivers that treatment with YCANTH can lead to local skin reactions [see Adverse Reactions (6.1) ] . Advise patients and/or caregivers not to use other topical products (e.g. creams, lotions, or sunscreen) until 24 hours after YCANTH treatment or until washing. Advise patients and/or caregivers to remove YCANTH with soap and water prior to 24 hours after treatment and contact the healthcare provider if severe blistering, severe pain or other severe adverse reactions occur [see Warnings and Precautions (5.2) ] . Flammability Inform patients and/or caregivers that YCANTH is flammable, even after drying. Instruct patients and/or caregivers to avoid fire, flame, or smoking near the lesions treated with YCANTH until YCANTH is removed [see Warnings and Precautions (5.3) ] . Important Dosage and Administration Information Inform patients and/or caregivers to remove YCANTH with soap and water 24 hours after treatment. Inform patients and/or caregivers that more than one YCANTH treatment may be necessary [see Dosage and Administration (2.2) ]."],"spl_unclassified_section":["Manufactured by: Pharmaceutical Packaging Solutions 341 JD Yarnell Industrial Pkwy, Clinton, TN 37716 For: Verrica Pharmaceuticals Inc. 44 West Gay Street, Suite 400 West Chester, PA 19380 YCANTH and VERRICA are registered trademarks of Verrica Pharmaceuticals Inc. Copyright © 2024 Verrica Pharmaceuticals Inc. All rights reserved."],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION All healthcare professionals should receive instruction and training prior to preparation and administration of YCANTH. ( 2.1 ) For topical use only. Not for oral, mucosal, or ophthalmic use. ( 2.1 ) Apply a single application directly to each lesion every 3 weeks as needed. ( 2.2 ) Do not use more than two applicators during a single treatment session. ( 2.2 ) Remove with soap and water 24 hours after treatment. ( 2.2 ) For additional instructions on preparation and administration of YCANTH, see Full Prescribing Information. ( 2.1 , 2.2 , 2.3 ) 2.1 Important Administration Instructions All healthcare professionals should receive instruction and training prior to preparation and administration of YCANTH. YCANTH is for topical use only. YCANTH is not for oral, mucosal, or ophthalmic use. Avoid contact with the treatment area, including oral contact, after YCANTH treatment. Do not apply YCANTH near the eyes [see Warnings and Precautions (5.1) , Overdosage (10) ] . If YCANTH contacts any unintended surface, including healthy skin, immediately remove by wiping with a cotton swab or gauze. Avoid other topical products on treated areas until 24 hours after YCANTH treatment or until washing [see Warnings and Precautions (5.2) ]. Avoid fire, flame or smoking near lesion(s) during treatment [see Warnings and Precautions (5.3) ] . 2.2 Dosage and Administration Overview Regarding YCANTH dosage and administration: Use nitrile or vinyl gloves and eye protection during preparation and administration. Apply topically as a single application to cover each lesion. Use no more than two YCANTH applicators during a single treatment session. Remove with soap and water 24 hours after treatment. Administer YCANTH every 3 weeks as needed. Do not cover any treated lesions with bandages. If severe blistering, severe pain, or other severe adverse reactions occur, remove YCANTH with soap and water prior to 24 hours after treatment [see Warnings and Precautions (5.2) ]. Regarding use of the YCANTH applicator and break tool: Do not reuse the applicator. The applicator is for a single treatment session only. Do not attempt to use a clogged applicator. Do not cut or modify the applicator in any way; doing so could reduce dispensing control. Do not remove the applicator cap prior to breaking the glass ampule. If any damage or leaks are observed on the applicator, applicators should be discarded in a sharps container and handled in accordance with accepted medical practice and applicable law. The YCANTH Break Tool should be managed as solid waste and placed in plastic recycling containers or the general trash. 2.3 Dosage and Administration Instructions Instructions for preparing the YCANTH Applicator and administering the YCANTH Solution are presented below. YCANTH includes the following components [see How Supplied/Storage and Handling (16.1) ] : Outer Protective Tube The YCANTH Applicator The YCANTH Break Tool Step 1. Put on Personal Protective Equipment (PPE) Put on gloves and eye protection. Step 2. Remove the YCANTH Applicator from Outer Protective Tube Use pull ring to remove purple end cap out of white outer protective tube. DO NOT remove the applicator cap. Slide the YCANTH Applicator out of the outer protective tube. Step 3. Remove the Paperboard Sleeve Completely remove the white paperboard sleeve so that the glass ampule is visible. DO NOT remove the applicator cap prior to breaking the glass ampule. Step 4. Inspect for Damage Inspect the YCANTH Applicator for the following types of damage: Broken glass ampule Cut or cracked applicator tube No damage (for reference) If any damage is observed, dispose of the YCANTH applicators in a sharps container and handle in accordance with accepted medical practice and applicable law. Step 5. Break Ampule using the YCANTH Break Tool Set the YCANTH Break Tool on a horizontal surface. Ensure the applicator cap is in place. Place the YCANTH Applicator in the YCANTH Break Tool with the cap pointing toward the hinge. Press down firmly on the YCANTH Break Tool until a snap is heard. Open the YCANTH Break Tool and remove the YCANTH Applicator. If any leaks are observed, applicators should be discarded in a sharps container and handled in accordance with accepted medical practice and applicable law. Step 6. Tap YCANTH Applicator to move YCANTH Solution Gently tap the capped end of the YCANTH Applicator on a horizontal surface for approximately 10 seconds or until the YCANTH Solution has collected at the bottom of the applicator tube. Step 7. Test the YCANTH Applicator Remove the applicator cap. Gently squeeze the applicator tube to apply a droplet to a paper towel or gauze to confirm the YCANTH Applicator is working properly. Step 8. Apply the YCANTH Solution Apply a small droplet of the YCANTH Solution onto a molluscum lesion. Use the applicator tip to spread the solution to cover the entire lesion. Repeat the application until all lesions have been treated. If YCANTH Solution contacts any unintended surface, including healthy skin, immediately remove by wiping with a cotton swab or gauze. DO NOT attempt to use a clogged YCANTH Applicator. Step 9. Allow YCANTH Solution to Dry Allow the YCANTH Solution to completely dry (up to 5 minutes) before contacting healthy skin to avoid transference. DO NOT cover any treated lesions with bandages. Step 10. Dispose of the YCANTH Applicator Applicators should be discarded in a sharps container and handled in accordance with accepted medical practice and applicable law. DO NOT reuse the YCANTH Applicator. YCANTH Break Tool Maintenance Wipe the surfaces of the YCANTH Break Tool with 70% isopropyl alcohol following each use. Inspect the YCANTH Break Tool for damage (e.g., cracks in plastic, missing or broken breaking posts) and function (e.g., hinge) prior to each use. After 12 uses or if any damage is observed, the YCANTH Break Tool should be managed as solid waste and placed in plastic recycling containers or the general trash. If needed, contact Verrica Pharmaceuticals Inc. at 1-973-298-1390 to request additional YCANTH Break Tools. Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure"],"spl_product_data_elements":["YCANTH Cantharidin Cantharidin cantharidin YCANTH Cantharidin Cantharidin cantharidin"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Topical solution 0.7%: Each mL of YCANTH contains 7 mg (0.7%) of cantharidin in a light violet to dark purple, slightly viscous liquid. Topical solution: 0.7% cantharidin. ( 3 )"],"spl_patient_package_insert":["This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 10/2024 PATIENT INFORMATION YCANTH (WYE' KANTH) (cantharidin) topical solution What is YCANTH? YCANTH is a prescription medicine used on the skin (topical) to treat molluscum contagiosum (molluscum bumps) in adults and children 2 years of age and older. It is not known if YCANTH is safe and effective in children under 2 years of age. Do not receive treatment with YCANTH if you are allergic to any of the ingredients in YCANTH. See the end of this leaflet for a complete list of ingredients in YCANTH. Before receiving treatment with YCANTH, tell your healthcare provider about all of your medical conditions, including if you: are being treated or have had treatments for molluscum bumps. have other skin problems. are pregnant or plan to become pregnant. It is not known if YCANTH can harm your unborn baby. are breastfeeding or plan to breastfeed. Your healthcare provider should avoid applying YCANTH to areas of your skin where your baby could come into contact with YCANTH and get it in their mouth or eyes. Talk to your healthcare provider about whether you should breastfeed while YCANTH is on your skin. Tell your healthcare provider about all the medications you take , including prescription and over-the-counter medicines, vitamins and herbal supplements. How will I receive treatment with YCANTH? Your healthcare provider will apply YCANTH to the areas on your skin with molluscum bumps. YCANTH is for use on the skin (topical use) only. YCANTH is not for use in your mouth, nose, genital areas, or in your eyes. You may need more than 1 treatment with YCANTH. Your healthcare provider may apply YCANTH about every 3 weeks as needed. Preparing for your treatment with YCANTH. On the day of treatment, do not apply topical steroids, creams, lotions, or sunscreen to areas with molluscum bumps. After your healthcare provider applies YCANTH to your molluscum bumps: Allow YCANTH to dry completely before leaving your healthcare provider's office or clinic (up to 5 minutes). Do not touch the treated areas for 24 hours or until washing. Do not allow treated areas of your skin to come into contact with your mouth, nose, genital areas, or your eyes for 24 hours or until washing. Do not allow children to lick or bite the treated areas. YCANTH contains a bittering agent to discourage young children from putting it in their mouths. See \" What are the ingredients in YCANTH? \" Do not apply topical steroids, creams, lotions, or sunscreen to treated areas for 24 hours after treatment or until you wash YCANTH off of your skin. Do not cover any of the treated areas with bandages. YCANTH contains a violet-colored dye. You may temporarily see the violet color on the treated areas of your skin. You may take over-the-counter pain relief medicines as needed. Wash the treated skin area with soap and water 24 hours after treatment unless your healthcare provider instructs you otherwise. You may wash YCANTH off of your skin sooner if you develop severe blistering, severe pain or other severe reactions. Do not use a washcloth, abrasive material or vigorous rubbing because this could be painful. Contact your healthcare provider with any questions. What should I avoid after receiving treatment with YCANTH? Avoid contact with the treated areas of your skin, including contact with your mouth (oral contact). Avoid applying other products to the treated areas of your skin until 24 hours after receiving treatment with YCANTH or until after washing YCANTH off of the treated areas of your skin . YCANTH is flammable, even after drying. Avoid fire, flame or smoking near lesion(s) during treatment and after treatment until YCANTH is washed off of your skin. What are the possible side effects of YCANTH? YCANTH can cause serious side effects, including: Serious side effects if YCANTH is swallowed or it comes into contact with your mouth or eyes . YCANTH can cause life threatening reactions or death if it gets into your or your child's mouth or is swallowed. These reactions can include: kidney failure blisters and severe damage to your stomach and intestine (intestinal tract) blood clotting problems seizures a certain type of paralysis If you or your child swallow (ingest) YCANTH, contact a Poison Control Center (1-800-222-1222) or go to the nearest hospital emergency room right away. Eye contact reactions. Severe eye injury can happen if YCANTH gets into your eyes. Contact with YCANTH in the eyes may cause: ulcers or small holes in your eyes scarring redness irritation severe eye pain permanent eye injury, including blindness If YCANTH accidentally gets into your eyes, flush them well with water for at least 15 minutes and get medical help right away. Skin reactions. Skin reactions are common at the areas where you have been treated with YCANTH, but can also sometimes be severe. Skin reactions with YCANTH may include: small fluid-filled or non-fluid filled raised blisters on or around treated area(s) pain itching scabs redness lightening or darkening of the skin in the treated area(s) dry skin at the treated area(s) swelling on or near the treated area(s) breakdown of the outer layer of skin at the treated area(s) If you develop severe blistering, severe pain or other severe reactions at the treated areas of your or your child's skin, wash YCANTH off of your skin sooner than 24 hours and call your healthcare provider. See \" How will I receive treatment with YCANTH? \" Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Verrica Pharmaceuticals Inc. at 1-877-837-7422. General information about the safe and effective use of YCANTH. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information that is written for health professionals. What are the ingredients in YCANTH? Active ingredient: cantharidin Inactive ingredients: acetone, camphor, castor oil, denatonium benzoate, ethanol, gentian violet, hydroxypropyl cellulose, and nitrocellulose. The inactive ingredient denatonium benzoate is a bittering agent to discourage young children from putting it in their mouths and accidentally swallowing YCANTH. Manufactured by: Pharmaceutical Packaging Solutions, 341 JD Yarnell Industrial Pkwy, Clinton, TN 37716 For: Verrica Pharmaceuticals Inc., 44 West Gay Street, Suite 400, West Chester, PA 19380. YCANTH and VERRICA are registered trademarks of Verrica Pharmaceuticals Inc. Copyright © 2024 Verrica Pharmaceuticals Inc. All rights reserved"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no available data with use of YCANTH in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies were not conducted with cantharidin. Given that systemic exposure to cantharidin following topical administration is low, maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology (12.3) ]. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 8.2 Lactation Risk Summary Avoid application of YCANTH topical solution to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child. There are no data on the presence of cantharidin in either human or animal milk, or the effects on the breastfed infant or on milk production. Breastfeeding is not expected to result in exposure of the child to the drug due to the low systemic absorption of YCANTH following topical administration [see Clinical Pharmacology (12.3) ]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for YCANTH topical solution and any potential adverse effects on the breastfeeding child from YCANTH topical solution or from the underlying maternal condition. 8.4 Pediatric Use Risk Summary The safety and effectiveness of YCANTH for the treatment of molluscum contagiosum have been established in pediatric patients aged 2 years and older. The use of YCANTH in pediatric patients is supported by results from adequate and well-controlled trials in patients 2 years of age and older; although the safety and efficacy of drug use for longer than 12 weeks has not been established [see Clinical Studies (14) ]. The safety and efficacy in pediatric patients below the age of 2 years have not been established . 8.5 Geriatric Use Risk Summary YCANTH has not been studied in geriatric patients."],"dosage_and_administration_table":["
Outer Protective Tube
The YCANTH Applicator
The YCANTH Break Tool
Step 1. Put on Personal Protective Equipment (PPE)Put on gloves and eye protection.
Step 2. Remove the YCANTH Applicator from Outer Protective TubeUse pull ring to remove purple end cap out of white outer protective tube.DO NOT remove the applicator cap.Slide the YCANTH Applicator out of the outer protective tube.
Step 3. Remove the Paperboard SleeveCompletely remove the white paperboard sleeve so that the glass ampule is visible.DO NOT remove the applicator cap prior to breaking the glass ampule.
Step 4. Inspect for DamageInspect the YCANTH Applicator for the following types of damage:
Broken glass ampule Cut or cracked applicator tube No damage (for reference)
If any damage is observed, dispose of the YCANTH applicators in a sharps container and handle in accordance with accepted medical practice and applicable law.
Step 5. Break Ampule using the YCANTH Break ToolSet the YCANTH Break Tool on a horizontal surface.Ensure the applicator cap is in place.Place the YCANTH Applicator in the YCANTH Break Tool with the cap pointing toward the hinge.Press down firmly on the YCANTH Break Tool until a snap is heard.Open the YCANTH Break Tool and remove the YCANTH Applicator.If any leaks are observed, applicators should be discarded in a sharps container and handled in accordance with accepted medical practice and applicable law.
Step 6. Tap YCANTH Applicator to move YCANTH SolutionGently tap the capped end of the YCANTH Applicator on a horizontal surface for approximately 10 seconds or until the YCANTH Solution has collected at the bottom of the applicator tube.
Step 7. Test the YCANTH ApplicatorRemove the applicator cap.Gently squeeze the applicator tube to apply a droplet to a paper towel or gauze to confirm the YCANTH Applicator is working properly.
Step 8. Apply the YCANTH SolutionApply a small droplet of the YCANTH Solution onto a molluscum lesion.Use the applicator tip to spread the solution to cover the entire lesion.Repeat the application until all lesions have been treated.If YCANTH Solution contacts any unintended surface, including healthy skin, immediately remove by wiping with a cotton swab or gauze.DO NOT attempt to use a clogged YCANTH Applicator.
Step 9. Allow YCANTH Solution to DryAllow the YCANTH Solution to completely dry (up to 5 minutes) before contacting healthy skin to avoid transference.DO NOT cover any treated lesions with bandages.
Step 10. Dispose of the YCANTH ApplicatorApplicators should be discarded in a sharps container and handled in accordance with accepted medical practice and applicable law.DO NOT reuse the YCANTH Applicator.
"],"spl_patient_package_insert_table":["
This Patient Information has been approved by the U.S. Food and Drug Administration.Issued: 10/2024
PATIENT INFORMATION YCANTH (WYE' KANTH) (cantharidin) topical solution
What is YCANTH? YCANTH is a prescription medicine used on the skin (topical) to treat molluscum contagiosum (molluscum bumps) in adults and children 2 years of age and older. It is not known if YCANTH is safe and effective in children under 2 years of age.
Do not receive treatment with YCANTH if you are allergic to any of the ingredients in YCANTH. See the end of this leaflet for a complete list of ingredients in YCANTH.
Before receiving treatment with YCANTH, tell your healthcare provider about all of your medical conditions, including if you:are being treated or have had treatments for molluscum bumps.have other skin problems.are pregnant or plan to become pregnant. It is not known if YCANTH can harm your unborn baby.are breastfeeding or plan to breastfeed. Your healthcare provider should avoid applying YCANTH to areas of your skin where your baby could come into contact with YCANTH and get it in their mouth or eyes. Talk to your healthcare provider about whether you should breastfeed while YCANTH is on your skin.Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
How will I receive treatment with YCANTH?Your healthcare provider will apply YCANTH to the areas on your skin with molluscum bumps.YCANTH is for use on the skin (topical use) only. YCANTH is not for use in your mouth, nose, genital areas, or in your eyes.You may need more than 1 treatment with YCANTH. Your healthcare provider may apply YCANTH about every 3 weeks as needed.Preparing for your treatment with YCANTH.On the day of treatment, do not apply topical steroids, creams, lotions, or sunscreen to areas with molluscum bumps.After your healthcare provider applies YCANTH to your molluscum bumps:Allow YCANTH to dry completely before leaving your healthcare provider's office or clinic (up to 5 minutes).Do not touch the treated areas for 24 hours or until washing. Do not allow treated areas of your skin to come into contact with your mouth, nose, genital areas, or your eyes for 24 hours or until washing. Do not allow children to lick or bite the treated areas. YCANTH contains a bittering agent to discourage young children from putting it in their mouths. See "What are the ingredients in YCANTH?"Do not apply topical steroids, creams, lotions, or sunscreen to treated areas for 24 hours after treatment or until you wash YCANTH off of your skin.Do not cover any of the treated areas with bandages.YCANTH contains a violet-colored dye. You may temporarily see the violet color on the treated areas of your skin.You may take over-the-counter pain relief medicines as needed.Wash the treated skin area with soap and water 24 hours after treatment unless your healthcare provider instructs you otherwise. You may wash YCANTH off of your skin sooner if you develop severe blistering, severe pain or other severe reactions. Do not use a washcloth, abrasive material or vigorous rubbing because this could be painful.Contact your healthcare provider with any questions.
What should I avoid after receiving treatment with YCANTH?Avoid contact with the treated areas of your skin, including contact with your mouth (oral contact). Avoid applying other products to the treated areas of your skin until 24 hours after receiving treatment with YCANTH or until after washing YCANTH off of the treated areas of your skin.YCANTH is flammable, even after drying. Avoid fire, flame or smoking near lesion(s) during treatment and after treatment until YCANTH is washed off of your skin.
What are the possible side effects of YCANTH? YCANTH can cause serious side effects, including:Serious side effects if YCANTH is swallowed or it comes into contact with your mouth or eyes.
YCANTH can cause life threatening reactions or death if it gets into your or your child's mouth or is swallowed. These reactions can include:
kidney failureblisters and severe damage to your stomach and intestine (intestinal tract)blood clotting problemsseizuresa certain type of paralysis
If you or your child swallow (ingest) YCANTH, contact a Poison Control Center (1-800-222-1222) or go to the nearest hospital emergency room right away.
Eye contact reactions. Severe eye injury can happen if YCANTH gets into your eyes. Contact with YCANTH in the eyes may cause:
ulcers or small holes in your eyesscarringrednessirritationsevere eye painpermanent eye injury, including blindness
If YCANTH accidentally gets into your eyes, flush them well with water for at least 15 minutes and get medical help right away.
Skin reactions. Skin reactions are common at the areas where you have been treated with YCANTH, but can also sometimes be severe. Skin reactions with YCANTH may include:
small fluid-filled or non-fluid filled raised blisters on or around treated area(s)painitchingscabsrednesslightening or darkening of the skin in the treated area(s)dry skin at the treated area(s)swelling on or near the treated area(s)breakdown of the outer layer of skin at the treated area(s)
If you develop severe blistering, severe pain or other severe reactions at the treated areas of your or your child's skin, wash YCANTH off of your skin sooner than 24 hours and call your healthcare provider. See "How will I receive treatment with YCANTH?"
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Verrica Pharmaceuticals Inc. at 1-877-837-7422.
General information about the safe and effective use of YCANTH. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information that is written for health professionals.
What are the ingredients in YCANTH? Active ingredient: cantharidin Inactive ingredients: acetone, camphor, castor oil, denatonium benzoate, ethanol, gentian violet, hydroxypropyl cellulose, and nitrocellulose. The inactive ingredient denatonium benzoate is a bittering agent to discourage young children from putting it in their mouths and accidentally swallowing YCANTH. Manufactured by: Pharmaceutical Packaging Solutions, 341 JD Yarnell Industrial Pkwy, Clinton, TN 37716 For: Verrica Pharmaceuticals Inc., 44 West Gay Street, Suite 400, West Chester, PA 19380. YCANTH and VERRICA are registered trademarks of Verrica Pharmaceuticals Inc. Copyright © 2024 Verrica Pharmaceuticals Inc. All rights reserved
"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 12 Ampule Applicator Package Carton FOR ADMINISTRATION BY A HEALTHCARE PROFESSIONAL ONLY NDC 71349-070-12 Rx Only 12 Applicators and 2 Break Tools Ycanth ® (cantharidin) TOPICAL SOLUTION 0.7% Single use applicator contains approximately 0.45 mL of 0.7% cantharidin solution. Each 1 mL of solution contains 7 mg cantharidin. Recommended Dosage: See prescribing information. For Topical Use Only. WARNING: Flammable liquid, even after drying. Avoid fire, flame or smoking near lesion(s) during treatment and after application until removed. WARNING: Highly Toxic! For Topical Use Only. YCANTH can be fatal if administered orally or taken internally. Wear gloves and eye protection during YCANTH ® preparation and administration. Remove the paperboard sleeve and inspect the applicator before using the break tool. If YCANTH contacts healthy skin, immediately remove by wiping with a cotton swab or gauze. If YCANTH gets in the eyes, flush eyes with water for at least 15 minutes and seek medical attention. PRINCIPAL DISPLAY PANEL - 12 Ampule Applicator Package Carton","PRINCIPAL DISPLAY PANEL - 6 Ampule Applicator Package Carton FOR ADMINISTRATION BY A HEALTHCARE PROFESSIONAL ONLY NDC 71349-999-06 Rx Only 6 Applicators and 2 Break Tools Ycanth ® (cantharidin) TOPICAL SOLUTION 0.7% Single use applicator contains approximately 0.45 mL of 0.7% cantharidin solution. Each 1 mL of solution contains 7 mg cantharidin. Recommended Dosage: See prescribing information. For Topical Use Only. Professional Sample. Not for Sale. WARNING: Flammable liquid, even after drying. Avoid fire, flame or smoking near lesion(s) during treatment and after application until removed. WARNING: Highly Toxic! For Topical Use Only. YCANTH can be fatal if administered orally or taken internally. Wear gloves and eye protection during YCANTH ® preparation and administration. Remove the paperboard sleeve and inspect the applicator before using the break tool. If YCANTH contacts healthy skin, immediately remove by wiping with a cotton swab or gauze. If YCANTH gets in the eyes, flush eyes with water for at least 15 minutes and seek medical attention. PRINCIPAL DISPLAY PANEL - 6 Ampule Applicator Package Carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been conducted with cantharidin. Cantharidin was not mutagenic in a bacteria reverse mutation (Ames) assay. An in vitro chromosomal aberration assay in human lymphocytes with cantharidin was inconclusive. Cantharidin was positive in an in vitro micronucleus assay in TK6 cells, primarily through an aneugenic mechanism. The effects of cantharidin on fertility have not been evaluated."]},"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Topical","category":"route"},{"label":"Liquid","category":"form"},{"label":"Solution","category":"form"},{"label":"Active","category":"status"},{"label":"Infection caused by Molluscum contagiosum","category":"indication"},{"label":"Verrica Pharms","category":"company"},{"label":"Approved 2020s","category":"decade"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Irritants","category":"pharmacology"},{"label":"Noxae","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"APPLICATION SITE VESICLES","source":"FDA FAERS","actionTaken":"57 reports"},{"date":"","signal":"APPLICATION SITE PAIN","source":"FDA FAERS","actionTaken":"40 reports"},{"date":"","signal":"BLISTER","source":"FDA FAERS","actionTaken":"27 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"14 reports"},{"date":"","signal":"ACCIDENTAL EXPOSURE TO PRODUCT","source":"FDA FAERS","actionTaken":"6 reports"},{"date":"","signal":"APPLICATION SITE BURN","source":"FDA FAERS","actionTaken":"6 reports"},{"date":"","signal":"APPLICATION SITE ERYTHEMA","source":"FDA FAERS","actionTaken":"5 reports"},{"date":"","signal":"BLISTER RUPTURE","source":"FDA FAERS","actionTaken":"5 reports"},{"date":"","signal":"APPLICATION SITE PRURITUS","source":"FDA FAERS","actionTaken":"4 reports"},{"date":"","signal":"APPLICATION SITE REACTION","source":"FDA FAERS","actionTaken":"4 reports"}],"commonSideEffects":[{"effect":"application site vesicles","drugRate":"60%","_validated":true,"placeboRate":"27%"},{"effect":"application site pain and pain","drugRate":"41%","_validated":true,"placeboRate":"16%"},{"effect":"application site pruritus and pruritus","drugRate":"47%","_validated":true,"placeboRate":"30%"},{"effect":"application site scab and scab","drugRate":"39%","_validated":true,"placeboRate":"20%"},{"effect":"application site erythema and erythema","drugRate":"24%","_validated":true,"placeboRate":"20%"},{"effect":"application site discoloration","drugRate":"28%","_validated":true,"placeboRate":"12%"},{"effect":"application site dryness","drugRate":"19%","_validated":true,"placeboRate":"14%"},{"effect":"application site edema","drugRate":"7%","_validated":true,"placeboRate":"3%"},{"effect":"application site erosion","drugRate":"6%","_validated":true,"placeboRate":"1%"}],"specialPopulations":{"Lactation":"Avoid application of YCANTH topical solution to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child. There are no data on the presence of cantharidin in either human or animal milk, or the effects on the breastfed infant or on milk production. Breastfeeding is not expected to result in exposure of the child to the drug due to the low systemic absorption of YCANTH following topical administration [see Clinical Pharmacology (12.3)]. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for YCANTH topical solution.","Pregnancy":"There are no available data with use of YCANTH in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies were not conducted with cantharidin. Given that systemic exposure to cantharidin following topical administration is low, maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology (12.3)]. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.","Geriatric use":"YCANTH has not been studied in geriatric patients.","Paediatric use":"The safety and effectiveness of YCANTH for the treatment of molluscum contagiosum have been established in pediatric patients aged 2 years and older. The use of YCANTH in pediatric patients is supported by results from adequate and well-controlled trials in patients 2 years of age and older; although the safety and efficacy of drug use for longer than 12 weeks has not been established [see Clinical Studies (14) ].The safety and efficacy in pediatric patients below the age of 2 years have not been established."},"discontinuationRates":[{"trial":"","drugArm":"2.3%","placeboArm":"0.5%","commonReason":"adverse reaction"}]},"trials":[],"aliases":[],"company":"Verrica Pharms","patents":[{"applNo":"N212905","source":"FDA Orange Book","status":"Active","expires":"Aug 22, 2038","useCode":"U-3663","territory":"US","drugProduct":true,"patentNumber":"12233042","drugSubstance":false},{"applNo":"N212905","source":"FDA Orange Book","status":"Active","expires":"Aug 22, 2038","useCode":"U-3663","territory":"US","drugProduct":true,"patentNumber":"11147790","drugSubstance":false},{"applNo":"N212905","source":"FDA Orange Book","status":"Active","expires":"May 28, 2035","useCode":"U-3665","territory":"US","drugProduct":true,"patentNumber":"11052064","drugSubstance":false},{"applNo":"N212905","source":"FDA Orange Book","status":"Active","expires":"Feb 19, 2041","useCode":"","territory":"US","drugProduct":true,"patentNumber":"12290651","drugSubstance":false}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CANTHARIDIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:00:49.674784+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T02:00:46.605652+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Cantharidin","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T02:01:02.598130+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:01:01.173438+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T02:00:45.144694+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CANTHARIDIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:01:02.003403+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:00:44.248655+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:00:44.248712+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T02:01:03.498382+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL48449/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:01:02.484819+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Local Skin Reactions [see Warnings and Precautions (5.2) ] Most common (incidence ≥1%) adverse reactions are the following local skin reactions at the application site: vesiculation, pain, pruritus, scabbing, erythema, discoloration, application site dryness, edema, and erosion. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Verrica Pharmaceuticals Inc. at 1-877-837-7422 or FDA at 1-800-FDA-1088 ","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:01:22.599013+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA212905","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:00:44.248723+00:00"}},"allNames":"ycanth","offLabel":[],"synonyms":["cantharidin","ycanth"],"timeline":[{"date":"2023-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from VERRICA PHARMS to Verrica Pharms"},{"date":"2023-07-21","type":"positive","source":"DrugCentral","milestone":"FDA approval (Verrica Pharms)"},{"date":"2028-07-21","type":"negative","source":"FDA Orange Book","milestone":"New Chemical Entity exclusivity expires"}],"brandName":"Ycanth","ecosystem":[{"indication":"Infection caused by Molluscum contagiosum","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","explanation":"The mechanism of action of cantharidin in the treatment of molluscum contagiosum is unknown.","oneSentence":"Cantharidin works by causing blistering and peeling of the skin, which helps to remove the Molluscum contagiosum virus.","technicalDetail":"Cantharidin is a vesicant that induces blistering and peeling of the skin through its cytotoxic effects, leading to the removal of infected cells and subsequent resolution of the infection."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Cantharidin","title":"Cantharidin","extract":"Cantharidin is an odorless, colorless fatty substance of the terpenoid class, which is secreted by many species of blister beetles. Its main current use in pharmacology is treating molluscum contagiosum and warts topically. It is a burn agent, poisonous in large doses. It has been historically used as an aphrodisiac. In its natural form, cantharidin is secreted by the male blister beetle, and given to the female as a copulatory gift during mating. Afterwards, the female beetle covers her eggs with it as a defense against predators.","wiki_history":"==History==\nthumb|left|[[Lytta vesicatoria|Spanish fly (Lytta vesicatoria), a beetle that secretes cantharidin]]\n\n===Aphrodisiac preparations===\nPreparations made from blister beetles (particularly \"Spanish fly\") have been used since ancient times as an aphrodisiac, possibly because their physical effects were perceived to mimic those of sexual arousal, and because they can cause prolonged erection or priapism in men. These preparations were known as cantharides, from the Greek word for \"beetle\".\n\nExamples of such use found in historical sources include:\n\n* The ancient Roman historian Tacitus relates that a cantharid preparation was used by the empress Livia, wife of Augustus Caesar, to entice members of the imperial family or dinner guests to commit sexual indiscretions (thus, providing her information to hold over them).\n* The German emperor Henry IV (1050–1106) is said to have consumed cantharides.\n* The French surgeon Ambroise Paré (1510–1590) described a case in 1572 of a man suffering from \"the most frightful satyriasis\" after taking a potion composed of nettles and a cantharid extract. This is perhaps the same man of whom Paré relates that a courtesan sprinkled a cantharid powder on food she served to him, after which the man experienced \"violent priapism\" and anal bleeding, of which he later died. Paré also cites the case of a priest who died of hematuria after swallowing a dose of cantharides, which he intended to fortify his sex drive.\n* Cantharides were in widespread use among the upper classes in France in the 1600s, despite being a banned substance. Police searches in connection with a rash of poisonings around 1680 turned up many stashes of \"bluish flies\", which were known to be used in the preparation of aphrodisiac potions.\n* Aphrodisiac sweets presumably laced with cantharides were circulated within libertine circles during the 1700s in France. 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