{"id":"natamycin","rwe":[{"pmid":"41901880","year":"2026","title":"Effect of Caffeic Acid and Natamycin on the Properties of Poly(butylene succinate) for Packaging Applications.","finding":"","journal":"Polymers","studyType":"Clinical Study"},{"pmid":"41867499","year":"2026","title":"Ion-activated mucoadhesive in situ gel incorporating terbinafine-loaded NLCs promotes ocular penetration and retention for enhanced fungal keratitis therapy.","finding":"","journal":"Materials today. Bio","studyType":"Clinical Study"},{"pmid":"41862140","year":"2026","title":"Smart Lipid-Based Nanocarrier System for the Topical Delivery of Ocular Therapeutics Bio-Interfacing, Physicochemical Diversity, and Routing Barriers.","finding":"","journal":"European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences","studyType":"Clinical Study"},{"pmid":"41840693","year":"2026","title":"Sustainable chromatographic assays of a novel antifungal combination for keratomycosis.","finding":"","journal":"BMC chemistry","studyType":"Clinical Study"},{"pmid":"41821138","year":"2026","title":"Functional insights into the biosynthesis of antifungal mandimycin.","finding":"","journal":"Pest management science","studyType":"Clinical Study"}],"_fda":{"id":"42678f74-383b-962f-e063-6394a90a3315","set_id":"20ede08c-0d39-dc65-e063-6394a90aa3e0","openfda":{"nui":["N0000175936","M0017172"],"unii":["8O0C852CPO"],"route":["OPHTHALMIC"],"rxcui":["204451","207100"],"spl_id":["42678f74-383b-962f-e063-6394a90a3315"],"brand_name":["NATACYN"],"spl_set_id":["20ede08c-0d39-dc65-e063-6394a90aa3e0"],"package_ndc":["82667-012-05"],"product_ndc":["82667-012"],"generic_name":["NATAMYCIN"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_cs":["Polyenes [CS]"],"substance_name":["NATAMYCIN"],"pharm_class_epc":["Polyene Antimicrobial [EPC]"],"manufacturer_name":["Harrow Eye, LLC"],"application_number":["NDA050514"],"is_original_packager":[true]},"version":"2","pregnancy":["Pregnancy: Animal reproduction studies have not been conducted with natamycin. It is also not known whether natamycin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. NATACYN ™ (natamycin ophthalmic suspension) 5% should be given to a pregnant woman only if clearly needed."],"description":["DESCRIPTION: NATACYN™ (natamycin ophthalmic suspension) 5% is a sterile, antifungal drug for topical ophthalmic administration. Each mL of NATACYN™ (natamycin ophthalmic suspension) contains: Active: natamycin 5% (50 mg). Preservative: benzalkonium chloride 0.02%. Inactive: sodium hydroxide and/or hydrochloric acid (neutralized to adjust the pH), purified water. The active ingredient is represented by the chemical structure: Established Name: Natamycin Molecular Formula: C 33 H 47 NO 13 Molecular Weight: 665.73 g/mol Chemical Name: Stereoisomer of 22-[(3-amino-3,6-dideoxy- β-D-mannopyranosyl)oxy]-1,3,26- trihydroxy-12- methyl-10-oxo-6,11,28- trioxatricyclo[22.3.1.05,7] octacosa-8,14,16,18,20-pentaene-25- carboxylic acid. Other: Pimaricin The pH range is 5.0-7.5. chemical"],"how_supplied":["HOW SUPPLIED: NATACYN™ (natamycin ophthalmic suspension) 5% is a 15 mL fill packaged in a 15 mL amber glass bottle with a black closure. A flint glass dropper with a red plastic closure and a black rubber bulb are packaged separately in a clear plastic blister with Tyvek backing. 15 mL NDC 82667-012-05 STORAGE: Store between 2°C to 24°C (36°F-75°F). Do not freeze . Avoid exposure to light and excessive heat. Rx Only"],"geriatric_use":["Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients."],"pediatric_use":["Pediatric Use: Safety and effectiveness in pediatric patients have not been established."],"effective_time":"20251030","adverse_reactions":["ADVERSE REACTIONS: The following events have been identified during post-marketing use of NATACYN ™ (natamycin ophthalmic suspension) 5% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to their seriousness, frequency of reporting, possible causal connection to NATACYN™ (natamycin ophthalmic suspension) 5%, or a combination of these factors include: allergic reaction, change in vision, chest pain, corneal opacity, dyspnea, eye discomfort, eye edema, eye hyperemia, eye irritation, eye pain, foreign body sensation, parethesia, and tearing."],"contraindications":["CONTRAINDICATIONS: NATACYN™ (natamycin ophthalmic suspension) 5% is contraindicated in individuals with a history of hypersensitivity to any of its components."],"general_precautions":["PRECAUTIONS: General. FOR TOPICAL OPHTHALMIC USE ONLY — NOT FOR INJECTION. Failure of improvement of keratitis following 7-10 days of administration of the drug suggests that the infection may be caused by a microorganism not susceptible to natamycin. Continuation of therapy should be based on clinical re-evaluation and additional laboratory studies. Adherence of the suspension to areas of epithelial ulceration or retention of the suspension in the fornices occurs regularly. Use only if the container is undamaged."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY: Natamycin is a tetraene polyene antibiotic derived from Streptomyces natalensis . It possesses in vitro activity against a variety of yeast and filamentous fungi, including Candida, Aspergillus, Cephalosporium, Fusarium and Penicillium . The mechanism of action appears to be through binding of the molecule to the sterol moiety of the fungal cell membrane. The polyenesterol complex alters the permeability of the membrane to produce depletion of essential cellular constituents. Although the activity against fungi is dose-related, natamycin is predominantly fungicidal. Natamycin is not effective in vitro against gram-positive or gram-negative bacteria. Topical administration appears to produce effective concentrations of natamycin within the corneal stroma but not in intraocular fluid. Systemic absorption should not be expected following topical administration of NATACYN™ (natamycin ophthalmic suspension) 5%. As with other polyene antibiotics, absorption from the gastrointestinal tract is very poor. Studies in rabbits receiving topical natamycin revealed no measurable compound in the aqueous humor or sera, but the sensitivity of the measurement was no greater than 2 mg/mL."],"indications_and_usage":["INDICATIONS AND USAGE: NATACYN™ (natamycin ophthalmic suspension) 5% is indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including Fusarium solani keratitis. As in other forms of suppurative keratitis, initial and sustained therapy of fungal keratitis should be determined by the clinical diagnosis, laboratory diagnosis by smear and culture of corneal scrapings and drug response. Whenever possible the in vitro activity of natamycin against the responsible fungus should be determined. The effectiveness of natamycin as a single agent in fungal endophthalmitis has not been established."],"information_for_patients":["Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the suspension. Patients should be advised not to wear contact lenses if they have signs and symptoms of fungal blepharitis, conjunctivitis, and keratitis."],"spl_unclassified_section":["Nursing Mothers: It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when natamycin is administered to a nursing woman.","Distributed by: Harrow Eye, LLC™ Nashville, TN USA Revised: 07/2024"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: SHAKE WELL BEFORE USING. The preferred initial dosage in fungal keratitis is one drop of NATACYN™ (natamycin ophthalmic suspension) 5% instilled in the conjunctival sac at hourly or two-hourly intervals. The frequency of application can usually be reduced to one drop 6 to 8 times daily after the first 3 to 4 days. Therapy should generally be continued for 14 to 21 days or until there is resolution of active fungal keratitis. In many cases, it may be helpful to reduce the dosage gradually at 4 to 7 day intervals to assure that the replicating organism has been eliminated. Less frequent initial dosage (4 to 6 daily applications) may be sufficient in fungal blepharitis and conjunctivitis."],"spl_product_data_elements":["NATACYN natamycin SODIUM HYDROXIDE HYDROCHLORIC ACID WATER BENZALKONIUM CHLORIDE NATAMYCIN NATAMYCIN"],"package_label_principal_display_panel":["NDC 82667-012-05 Harrow ® Natacyn™ (natamycin ophthalmic suspension) 5% Anti-Fungal Ophthalmic Suspension Rx Only 15 mL Sterile Natacyn_Carton.jpg"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility: There have been no long term studies done using natamycin in animals to evaluate carcinogenesis, mutagenesis, or impairment of fertility."]},"tags":[{"label":"Polyene Antimicrobial","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"A01AB10","category":"atc"},{"label":"Ophthalmic","category":"route"},{"label":"Suspension/ Drops","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Fungal Blepharitis","category":"indication"},{"label":"Fungal conjunctivitis","category":"indication"},{"label":"Fungal keratitis","category":"indication"},{"label":"Harrow Eye","category":"company"},{"label":"Approved 1970s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Anti-Infective Agents, Local","category":"pharmacology"},{"label":"Antifungal Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":80.897,"date":"","count":18,"signal":"Appendicolith","source":"DrugCentral FAERS","actionTaken":"Reported 18 times (LLR=81)"},{"llr":71.218,"date":"","count":17,"signal":"Blood phosphorus increased","source":"DrugCentral FAERS","actionTaken":"Reported 17 times (LLR=71)"}],"commonSideEffects":[{"effect":"allergic reaction","drugRate":"reported","severity":"unknown"},{"effect":"change in vision","drugRate":"reported","severity":"unknown"},{"effect":"chest pain","drugRate":"reported","severity":"unknown"},{"effect":"corneal opacity","drugRate":"reported","severity":"unknown"},{"effect":"dyspnea","drugRate":"reported","severity":"unknown"},{"effect":"eye discomfort","drugRate":"reported","severity":"unknown"},{"effect":"eye edema","drugRate":"reported","severity":"unknown"},{"effect":"eye hyperemia","drugRate":"reported","severity":"unknown"},{"effect":"eye irritation","drugRate":"reported","severity":"unknown"},{"effect":"eye pain","drugRate":"reported","severity":"unknown"},{"effect":"foreign body sensation","drugRate":"reported","severity":"unknown"},{"effect":"parethesia","drugRate":"reported","severity":"unknown"},{"effect":"tearing","drugRate":"reported","severity":"unknown"}],"specialPopulations":{"Pregnancy":"Pregnant woman should be given NATACYN(R) only if clearly needed. It is also not known whether natamycin can cause fetal harm when administered to pregnant woman or can affect reproduction capacity.","Geriatric use":"No overall differences in safety or effectiveness have been observed between elderly and younger patients.","Paediatric use":"Safety and effectiveness in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Harrow Health","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=NATAMYCIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:08:56.810810+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Natamycin","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T02:09:03.909086+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:09:02.460863+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=NATAMYCIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:09:02.841825+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:08:55.684958+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:08:55.684994+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:08:55.684999+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Ergosterol sequestering agent","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:09:03.909028+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200656/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:09:03.556886+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA050514","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:08:55.685002+00:00"}},"allNames":"natacyn","offLabel":[],"synonyms":["pimaricin","tennecetin","natamycin","myuprozine","pimafucin"],"timeline":[{"date":"1978-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ALCON to Harrow Eye"},{"date":"1978-10-30","type":"positive","source":"DrugCentral","milestone":"FDA approval (Alcon)"}],"aiSummary":"Natacyn (Natamycin) is a polyene antimicrobial small molecule developed by Alcon and currently owned by Harrow Eye. It is FDA-approved since 1978 for treating fungal blepharitis, conjunctivitis, and keratitis. As an off-patent medication, it is not commercially available as a generic. Natacyn works by binding to ergosterol in fungal cell membranes, disrupting their integrity and ultimately leading to cell death. It is a critical treatment option for ocular fungal infections.","approvals":[{"date":"1978-10-30","orphan":false,"company":"ALCON","regulator":"FDA"}],"brandName":"Natacyn","ecosystem":[{"indication":"Fungal Blepharitis","otherDrugs":[],"globalPrevalence":null},{"indication":"Fungal conjunctivitis","otherDrugs":[],"globalPrevalence":null},{"indication":"Fungal keratitis","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"novelty":"Follow-on","modality":"Small Molecule","drugClass":"Polyene Antimicrobial [EPC]","explanation":"","oneSentence":"","technicalDetail":"Natacyn binds to ergosterol, a critical component of fungal cell membranes, through a hydrophobic interaction, ultimately disrupting membrane integrity and leading to cell lysis."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Natamycin","title":"Natamycin","extract":"Natamycin, also known as pimaricin, is an antifungal medication used to treat fungal infections around the eye. This includes infections of the eyelids, conjunctiva, and cornea. It is used as eyedrops. Natamycin is also used in the food industry as a preservative.","wiki_history":"== History ==\nNatamycin was first isolated in 1955 from fermentation broth of a Streptomyces natalensis cell culture. It was originally named pimaricin to honor Pietermaritzburg, where Streptomyces natalensis was acquired. Pimaricin was later renamed after the World Health Organization (WHO) mandated that antibiotics produced by Streptomyces end in –mycin. The name natamycin was chosen in reference to the natalensis species name.","wiki_society_and_culture":"==Society and culture==\nNatamycin appears on Whole Foods' \"Unacceptable Ingredients for Food\" list."},"commercial":{"launchDate":"1978","_launchSource":"DrugCentral (FDA 1978-10-30, ALCON)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1885","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=NATAMYCIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=NATAMYCIN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Natamycin","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T15:04:46.996599","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T02:09:06.408831+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"hydrogen peroxide","drugSlug":"hydrogen-peroxide","fdaApproval":"","patentExpiry":"Jul 4, 2035","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"chlorhexidine","drugSlug":"chlorhexidine","fdaApproval":"1976-09-17","patentExpiry":"Oct 2, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"amphotericin B","drugSlug":"amphotericin-b","fdaApproval":"1964-11-12","genericCount":9,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"oxyquinoline","drugSlug":"oxyquinoline","fdaApproval":"","relationship":"same-class"},{"drugName":"neomycin","drugSlug":"neomycin","fdaApproval":"1957-03-26","genericCount":12,"patentStatus":"Off-patent — generic 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protected","relationship":"same-class"},{"drugName":"minocycline","drugSlug":"minocycline","fdaApproval":"1971-06-30","patentExpiry":"Sep 8, 2037","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"oxytetracycline","drugSlug":"oxytetracycline","fdaApproval":"1964-09-08","patentStatus":"Unknown","relationship":"same-class"}],"genericName":"natamycin","indications":{"approved":[{"name":"Fungal Blepharitis","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Fungal conjunctivitis","source":"DrugCentral","snomedId":231862003,"regulator":"FDA"},{"name":"Fungal keratitis","source":"DrugCentral","snomedId":314558005,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"currentOwner":"Harrow Eye","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"hydrogen-peroxide","brandName":"hydrogen peroxide","genericName":"hydrogen 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Bengal Electromagnetic Activation With Green Light for Infection Reduction","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2022-08-03","conditions":["Acanthamoeba Keratitis","Fungal Keratitis"],"enrollment":330,"completionDate":"2025-06-30"},{"nctId":"NCT06463678","phase":"PHASE2","title":"Trial to Evaluate the Efficacy And Safety of IVIEW-1201 In the Treatment of Fungal Keratitis","status":"NOT_YET_RECRUITING","sponsor":"IVIEW Therapeutics Inc.","startDate":"2026-08-01","conditions":["Fungal Keratitis"],"enrollment":60,"completionDate":"2027-12-31"},{"nctId":"NCT06658002","phase":"PHASE3","title":"Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A","status":"RECRUITING","sponsor":"University of California, San Francisco","startDate":"2025-09-01","conditions":["Fungal Keratitis","Corneal Ulcer"],"enrollment":150,"completionDate":"2027-09-01"},{"nctId":"NCT02731638","phase":"PHASE3","title":"Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2016-09","conditions":["Corneal Ulcer","Fungal Keratitis"],"enrollment":70,"completionDate":"2018-07"},{"nctId":"NCT02570321","phase":"PHASE3","title":"Cross-linking for Corneal Ulcers Treatment Trial","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2015-11","conditions":["Corneal Ulcer","Infectious Keratitis","Bacterial Ulcer","Fungal Ulcer"],"enrollment":147,"completionDate":"2019-03-19"},{"nctId":"NCT06411314","phase":"PHASE3","title":"Efficacy and Safety of Natamycin and Lactulose Vaginal Suppositories in Treatment of Vulvovaginal Candidiasis","status":"COMPLETED","sponsor":"Avva Rus, JSC","startDate":"2022-12-29","conditions":["Vulvovaginal Candidiasis, Genital"],"enrollment":218,"completionDate":"2023-09-22"},{"nctId":"NCT05655689","phase":"","title":"The Antibiogram and Outcomes of Antimicrobial Regimens in Microbial Keratitis: A Prospective Cohort Study","status":"COMPLETED","sponsor":"Alexandria University","startDate":"2021-12-31","conditions":["Bacterial Keratitis","Fungal Keratitis","Mixed Bacterial and Fungal Keratitis","Microbial Keratitis"],"enrollment":123,"completionDate":"2023-01-01"},{"nctId":"NCT00997035","phase":"PHASE3","title":"The Mycotic Ulcer Treatment Trial II: A Randomized Trial Comparing Oral Voriconazole vs Placebo","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2010-05","conditions":["Corneal Ulcer","Eye Infections, Fungal"],"enrollment":240,"completionDate":"2016-03"},{"nctId":"NCT00557362","phase":"PHASE1,PHASE2","title":"Therapeutic Exploratory Study of Comparing Natamycin and Voriconazole to Treat Fungal Corneal Ulcer","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2007-11","conditions":["Fungal 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