{"id":"dexpanthenol","rwe":[{"pmid":"41901271","year":"2026","title":"Preparation and Investigation of Artemisia annua L.-Loaded Alginate Hydrogels with Excipients.","finding":"","journal":"Pharmaceuticals (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41775114","year":"2026","title":"Translational framework combining machine learning and in vivo screening for aminoglycoside ototoxicity prevention.","finding":"","journal":"Hearing research","studyType":"Clinical Study"},{"pmid":"41680294","year":"2026","title":"Dexpanthenol mitigates trauma-induced lung injury by modulating RIPK1/RIPK3/MLKL-mediated necroptosis in rats.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"41566030","year":"2026","title":"Effect of preoperative topical dexpanthenol moisturizer on the prevention of angular cheilitis after pediatric adenotonsillectomy: a prospective randomized controlled trial.","finding":"","journal":"European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery","studyType":"Clinical Study"},{"pmid":"41531936","year":"2026","title":"3D printed system using ex vivo porcine eye globes to investigate intracorneal absorption of dexpanthenol from contact lens care solution and eye drops.","finding":"","journal":"International journal of pharmaceutics: X","studyType":"Clinical Study"}],"_fda":{"id":"a7704aa3-bd3d-479e-8469-767d59636c7e","set_id":"282ccec8-9bcd-4571-9b91-bbb96ef2620d","openfda":{"unii":["1O6C93RI7Z","25X51I8RD4","68Y4CF58BV","20RD1DZH99","M572600E5P"],"route":["INTRAVENOUS"],"rxcui":["801177"],"spl_id":["a7704aa3-bd3d-479e-8469-767d59636c7e"],"brand_name":["Vitamin B Complex"],"spl_set_id":["282ccec8-9bcd-4571-9b91-bbb96ef2620d"],"package_ndc":["67457-146-30"],"product_ndc":["67457-146"],"generic_name":["THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["DEXPANTHENOL","NIACINAMIDE","PYRIDOXINE HYDROCHLORIDE","RIBOFLAVIN 5'-PHOSPHATE SODIUM","THIAMINE HYDROCHLORIDE"],"manufacturer_name":["Mylan Institutional LLC"],"is_original_packager":[true]},"version":"8","warnings":["WARNINGS Anaphylactogenesis may occur with parenteral thiamine. Use with caution. An intradermal test dose is recommended prior to administration in patients suspected of being sensitive to the drug."],"description":["DESCRIPTION Vitamin B-Complex 100 Injection is a sterile solution for intramuscular or slow intravenous injection comprised of vitamins which may be categorized as belonging to the vitamin B complex group. Each mL contains: Thiamine Hydrochloride 100 mg, Riboflavin 5’ Phosphate Sodium 2 mg, Pyridoxine Hydrochloride 2 mg, Dexpanthenol 2 mg, Niacinamide 100 mg, with Benzyl Alcohol 2% as preservative, in Water for Injection. Sodium Hydroxide and/or Hydrochloric Acid may have been used to adjust pH."],"precautions":["PRECAUTIONS The usual precautions for parenteral administration should be observed. Do not inject if precipitation occurs. Inject slowly by the intravenous route. High concentrations should be diluted using Normal Saline Injection when given intravenously."],"how_supplied":["HOW SUPPLIED Vitamin B-Complex 100 Injection is available in a 30 mL multiple-dose vial individually boxed. Phase separation due to reduced solubility can occur under certain conditions of shipping or storage (e.g. accidental freezing), which may produce visible particles. Do not use product if these do not redissolve on warming to body temperature and shaking well. Refrigeration of the product may cause darkening of the solution due to the riboflavin content. The colour does not affect the safety or efficacy of the product. PROTECT FROM LIGHT: Store in carton until contents are used. Store under refrigeration 2° to 8°C (36° to 46°F). Do not permit to freeze. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland 0415L107 Revised: 9/2021 MI:VITBIJ:R4"],"effective_time":"20210915","adverse_reactions":["ADVERSE REACTIONS Mild transient diarrhea, polycythemia vera, peripheral vascular thrombosis, itching transitory exanthema, feeling of swelling of entire body, anaphylactic shock and death. Sensitivity to the ingredients listed may occur (see WARNINGS ). Use should be discontinued upon observance of any untoward reaction. Pain upon intramuscular injection may be noted."],"contraindications":["CONTRAINDICATIONS Sensitivity to the ingredients listed."],"indications_and_usage":["INDICATIONS AND USAGE In disorders requiring parenteral administration of vitamins, i.e. pre- and post-operative treatment, when requirements are increased as in fever, severe burns, increased metabolism, pregnancy, gastrointestinal disorders interfering with intake or absorption of vitamins, prolonged or wasting diseases, alcoholism and where other deficiencies exist."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usually 0.25 to 2 mL by intramuscular or slow intravenous injection. High concentrations given intravenously may be diluted using parenteral infusion solutions. (See PRECAUTIONS .) Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit (see HOW SUPPLIED )."],"spl_product_data_elements":["Vitamin B Complex thiamine hydrochloride, riboflavin 5 phosphate sodium, dexpanthenol and niacinamide THIAMINE HYDROCHLORIDE THIAMINE ION THIAMINE RIBOFLAVIN 5'-PHOSPHATE SODIUM FLAVIN MONONUCLEOTIDE DEXPANTHENOL DEXPANTHENOL NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE BENZYL ALCOHOL WATER HYDROCHLORIC ACID SODIUM HYDROXIDE"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 mL NDC 67457-146-30 30 mL Vitamin B-Complex 100 Injection For Intramuscular or Slow Intravenous Use Rx only Multi-Dose Vial Sterile Each mL contains: Thiamine HCl 100 mg, Riboflavin 5' Phosphate Sodium 2 mg, Pyridoxine HCl 2 mg, Dexpanthenol 2 mg, Niacinamide 100 mg, with Benzyl Alcohol 2% as preservative, in Water for Injection. Sodium Hydroxide and/or Hydrochloric Acid may have been used to adjust pH. Warning: Anaphylactogenesis to parenteral thiamine has been reported. Use with caution. Usual Dosage: See accompanying prescribing information. STORE UNDER REFRIGERATION 2° TO 8°C (36° TO 46°F). DO NOT FREEZE. Protect from light. Store in carton until contents are used. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland MI:146:1C:R4 Mylan.com Vitamin B-Complex 100 Injection Carton Label"]},"tags":[{"label":"dexpanthenol","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"A11HA30","category":"atc"},{"label":"Intramuscular","category":"route"},{"label":"Topical","category":"route"},{"label":"Intravenous","category":"route"},{"label":"Cream","category":"form"},{"label":"Gel","category":"form"},{"label":"Injection","category":"form"},{"label":"Liquid","category":"form"},{"label":"Active","category":"status"},{"label":"Arthropod bite wound","category":"indication"},{"label":"Contact dermatitis due to poison oak","category":"indication"},{"label":"Diaper rash","category":"indication"},{"label":"Disorder of skin","category":"indication"},{"label":"Eczema","category":"indication"},{"label":"Gastroparesis","category":"indication"},{"label":"Hospira","category":"company"},{"label":"Approved 1950s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":226.72,"date":"","count":116,"signal":"Pneumonia aspiration","source":"DrugCentral FAERS","actionTaken":"Reported 116 times (LLR=227)"},{"llr":204.464,"date":"","count":132,"signal":"Gastrooesophageal reflux disease","source":"DrugCentral FAERS","actionTaken":"Reported 132 times (LLR=204)"},{"llr":164.759,"date":"","count":108,"signal":"Coma","source":"DrugCentral FAERS","actionTaken":"Reported 108 times (LLR=165)"},{"llr":127.813,"date":"","count":140,"signal":"Somnolence","source":"DrugCentral FAERS","actionTaken":"Reported 140 times (LLR=128)"},{"llr":48.014,"date":"","count":15,"signal":"Tumour pain","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=48)"},{"llr":43.846,"date":"","count":35,"signal":"Underdose","source":"DrugCentral FAERS","actionTaken":"Reported 35 times (LLR=44)"},{"llr":36.076,"date":"","count":16,"signal":"Female genital tract fistula","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=36)"},{"llr":34.711,"date":"","count":6,"signal":"Anterior segment ischaemia","source":"DrugCentral FAERS","actionTaken":"Reported 6 times (LLR=35)"},{"llr":33.032,"date":"","count":29,"signal":"Incorrect route of product administration","source":"DrugCentral FAERS","actionTaken":"Reported 29 times (LLR=33)"},{"llr":30.695,"date":"","count":6,"signal":"Pulmonary vein occlusion","source":"DrugCentral FAERS","actionTaken":"Reported 6 times (LLR=31)"},{"llr":29.102,"date":"","count":11,"signal":"Vaginal flatulence","source":"DrugCentral FAERS","actionTaken":"Reported 11 times (LLR=29)"},{"llr":28.896,"date":"","count":18,"signal":"Febrile bone marrow aplasia","source":"DrugCentral FAERS","actionTaken":"Reported 18 times (LLR=29)"},{"llr":27.28,"date":"","count":17,"signal":"Chronic sinusitis","source":"DrugCentral FAERS","actionTaken":"Reported 17 times (LLR=27)"},{"llr":26.565,"date":"","count":15,"signal":"Breast cancer metastatic","source":"DrugCentral FAERS","actionTaken":"Reported 15 times (LLR=27)"},{"llr":26.496,"date":"","count":101,"signal":"Anaemia","source":"DrugCentral FAERS","actionTaken":"Reported 101 times (LLR=26)"}],"commonSideEffects":[{"effect":"Pneumonia aspiration","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Gastrooesophageal reflux disease","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Coma","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Somnolence","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Tumour pain","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Underdose","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Female genital tract fistula","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Anterior segment ischaemia","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Incorrect route of product administration","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Pulmonary vein occlusion","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Vaginal flatulence","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Febrile bone marrow aplasia","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Chronic sinusitis","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Breast cancer metastatic","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Anaemia","drugRate":"","severity":"common","_validated":false,"_confidence":0.3}],"contraindications":["Hemophilia"]},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DEXPANTHENOL","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:07:02.397243+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:07:07.564576+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DEXPANTHENOL","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:07:07.928281+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:07:01.272485+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:07:01.272508+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200979/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:07:08.625504+00:00"}},"allNames":"infuvite adult","offLabel":[],"synonyms":["dexpanthenol","(+)-panthenol","bepanthen","D-Panthenol"],"timeline":[{"date":"1953-02-20","type":"positive","source":"DrugCentral","milestone":"FDA approval (Hospira)"}],"approvals":[{"date":"1953-02-20","orphan":false,"company":"HOSPIRA","regulator":"FDA"}],"brandName":"Infuvite Adult","ecosystem":[{"indication":"Arthropod bite wound","otherDrugs":[{"name":"ferric oxide","slug":"ferric-oxide","company":""},{"name":"pramocaine","slug":"pramocaine","company":"Sebela Ireland Ltd"},{"name":"zinc acetate","slug":"zinc-acetate","company":"Armour Pharm"},{"name":"zinc oxide","slug":"zinc-oxide","company":"Delcor Asset"}],"globalPrevalence":null},{"indication":"Contact dermatitis due to poison oak","otherDrugs":[],"globalPrevalence":324000000},{"indication":"Diaper rash","otherDrugs":[{"name":"amphotericin B","slug":"amphotericin-b","company":"Apothecon"},{"name":"clotrimazole","slug":"clotrimazole","company":""},{"name":"dimethicone","slug":"dimethicone","company":"Mcneil"},{"name":"levomenthol","slug":"levomenthol","company":""}],"globalPrevalence":null},{"indication":"Disorder of skin","otherDrugs":[{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""},{"name":"methylprednisolone","slug":"methylprednisolone","company":"Pharmacia And Upjohn"}],"globalPrevalence":null},{"indication":"Eczema","otherDrugs":[],"globalPrevalence":null},{"indication":"Gastroparesis","otherDrugs":[],"globalPrevalence":912000},{"indication":"Paralytic Ileus Prevention","otherDrugs":[],"globalPrevalence":null},{"indication":"Paralytic ileus","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"novelty":"First-in-class","modality":"Small Molecule","drugClass":"dexpanthenol","explanation":"","oneSentence":"","technicalDetail":"Dexpanthenol is a prodrug that undergoes reduction to form pantothenic acid, which is then incorporated into coenzyme A, a crucial molecule for various cellular processes, including fatty acid synthesis and energy metabolism."},"commercial":{"launchDate":"1953","_launchSource":"DrugCentral (FDA 1953-02-20, HOSPIRA)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/838","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=DEXPANTHENOL","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DEXPANTHENOL","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T10:32:13.015866","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T02:07:11.360198+00:00","fieldsConflicting":16,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"nicotinamide","drugSlug":"nicotinamide","fdaApproval":"1953-02-20","relationship":"same-class"},{"drugName":"pyridoxine","drugSlug":"pyridoxine","fdaApproval":"1993-12-29","genericCount":10,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"Vitamin E","drugSlug":"vitamin-e","fdaApproval":"1953-02-20","relationship":"same-class"},{"drugName":"riboflavin","drugSlug":"riboflavin","fdaApproval":"1953-02-20","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"biotin","drugSlug":"biotin","fdaApproval":"1953-02-20","relationship":"same-class"},{"drugName":"pyridoxal phosphate","drugSlug":"pyridoxal-phosphate","fdaApproval":"","relationship":"same-class"},{"drugName":"inositol","drugSlug":"inositol","fdaApproval":"","relationship":"same-class"},{"drugName":"tocofersolan","drugSlug":"tocofersolan","fdaApproval":"","relationship":"same-class"},{"drugName":"calcium pantothenate","drugSlug":"calcium-pantothenate","fdaApproval":"1993-12-29","relationship":"same-class"},{"drugName":"pantethine","drugSlug":"pantethine","fdaApproval":"","relationship":"same-class"}],"genericName":"dexpanthenol","indications":{"approved":[{"name":"Arthropod bite wound","source":"DrugCentral","snomedId":409985002,"regulator":"FDA","eligibility":null},{"name":"Contact dermatitis due to poison oak","source":"DrugCentral","snomedId":200824008,"regulator":"FDA","eligibility":null,"usPrevalence":null,"globalPrevalence":324000000,"prevalenceMethod":"curated","prevalenceSource":"Contact Dermatitis, 2025 (PMID:40107276)"},{"name":"Diaper rash","source":"DrugCentral","snomedId":91487003,"regulator":"FDA","eligibility":null},{"name":"Disorder of skin","source":"DrugCentral","snomedId":95320005,"regulator":"FDA","eligibility":null},{"name":"Eczema","source":"DrugCentral","snomedId":43116000,"regulator":"FDA","eligibility":null},{"name":"Gastroparesis","source":"DrugCentral","snomedId":235675006,"regulator":"FDA","eligibility":null,"prevalenceClass":"1-5 / 10 000","globalPrevalence":912000,"prevalenceMethod":"orphanet","prevalenceSource":"Orphanet (ORPHANET_30396519[PMID])"},{"name":"Paralytic Ileus Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":null},{"name":"Paralytic ileus","source":"DrugCentral","snomedId":55525008,"regulator":"FDA","eligibility":null},{"name":"Toxicodendron radicans","source":"DrugCentral","snomedId":52352005,"regulator":"FDA","eligibility":null}],"offLabel":[{"name":"Chafing of skin","source":"DrugCentral","drugName":"DEXPANTHENOL","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Eruption of skin","source":"DrugCentral","drugName":"DEXPANTHENOL","evidenceCount":2,"evidenceLevel":"emerging"},{"name":"Itching of skin","source":"DrugCentral","drugName":"DEXPANTHENOL","evidenceCount":13,"evidenceLevel":"moderate"},{"name":"Skin irritation","source":"DrugCentral","drugName":"DEXPANTHENOL","evidenceCount":17,"evidenceLevel":"moderate"}],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"nicotinamide","brandName":"nicotinamide","genericName":"nicotinamide","approvalYear":"1953","relationship":"same-class"},{"drugId":"pyridoxine","brandName":"pyridoxine","genericName":"pyridoxine","approvalYear":"1993","relationship":"same-class"},{"drugId":"vitamin-e","brandName":"Vitamin E","genericName":"Vitamin E","approvalYear":"1953","relationship":"same-class"},{"drugId":"riboflavin","brandName":"riboflavin","genericName":"riboflavin","approvalYear":"1953","relationship":"same-class"},{"drugId":"biotin","brandName":"biotin","genericName":"biotin","approvalYear":"1953","relationship":"same-class"},{"drugId":"pyridoxal-phosphate","brandName":"pyridoxal phosphate","genericName":"pyridoxal phosphate","approvalYear":"","relationship":"same-class"},{"drugId":"inositol","brandName":"inositol","genericName":"inositol","approvalYear":"","relationship":"same-class"},{"drugId":"tocofersolan","brandName":"tocofersolan","genericName":"tocofersolan","approvalYear":"","relationship":"same-class"},{"drugId":"calcium-pantothenate","brandName":"calcium pantothenate","genericName":"calcium pantothenate","approvalYear":"1993","relationship":"same-class"},{"drugId":"pantethine","brandName":"pantethine","genericName":"pantethine","approvalYear":"","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07431385","phase":"NA","title":"Performance and Safety of IRIDIUM GARZE in Blepharitis or Blepharconjunctivitis Adjuvant Treatment","status":"RECRUITING","sponsor":"Fidia Farmaceutici s.p.a.","startDate":"2025-09-17","conditions":["Blepharitis","Blepharoconjunctivitis"],"enrollment":80,"completionDate":"2026-06"},{"nctId":"NCT07395674","phase":"NA","title":"Subcutaneous Dexpanthenol Administration and Wound Epithelialization","status":"NOT_YET_RECRUITING","sponsor":"Dilara CANBAY OZDEMIR","startDate":"2026-03-02","conditions":["Chronic Wounds","Diabetic Foot Ulcer","Venous Leg Ulcers","Arterial Ulcer"],"enrollment":40,"completionDate":"2026-07-02"},{"nctId":"NCT07271212","phase":"NA","title":"Scalp Care Efficacy Evaluation for Premium Revitalizing Elixir","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hungkuang University","startDate":"2025-11-01","conditions":["Scalp Health","Hair Condition","Hair Loss","Alopecia","Sebum Production","Hair Health","Hair Thinning"],"enrollment":60,"completionDate":"2026-05"},{"nctId":"NCT06985121","phase":"NA","title":"Scalp Care Efficacy Evaluation for Premium Scalp Revitalizing Essence","status":"COMPLETED","sponsor":"Hungkuang University","startDate":"2025-04-08","conditions":["Scalp Health","Hair Condition","Hair Loss","Sebum Production","Hair and Scalp Health"],"enrollment":60,"completionDate":"2025-07-31"},{"nctId":"NCT07067476","phase":"NA","title":"Instant Flush Redness Clinical Efficacy Study","status":"NOT_YET_RECRUITING","sponsor":"ChinaNorm","startDate":"2025-07-15","conditions":["Sensitive Skin"],"enrollment":60,"completionDate":"2025-10-31"},{"nctId":"NCT07002632","phase":"NA","title":"Using Dexpanthenol Cream to Prevent Lip Corner Cracks in Children After Tonsil/Adenoid Surgery","status":"COMPLETED","sponsor":"Gaziosmanpasa Research and Education Hospital","startDate":"2021-07-20","conditions":["Cheilitis, Angular","Postoperative Complications","Adenotonsillar Hypertrophy"],"enrollment":106,"completionDate":"2024-06-05"},{"nctId":"NCT06875687","phase":"NA","title":"Prostaglandin Analog Eyelash Serum and Ocular Surface Health: A Prospective Study","status":"COMPLETED","sponsor":"University of Seville","startDate":"2025-01-15","conditions":["Dry Eye"],"enrollment":19,"completionDate":"2025-02-28"},{"nctId":"NCT06370585","phase":"PHASE1","title":"Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2024-05-16","conditions":["Dry Eye Disease","Ocular Surface Disease"],"enrollment":36,"completionDate":"2024-11-13"},{"nctId":"NCT06822608","phase":"PHASE4","title":"Evaluation of Dexpanthenol and Hyaluronic Acid Eye Drops on Corneal Epithelialization After Trans Epithelial PRK","status":"NOT_YET_RECRUITING","sponsor":"National and Kapodistrian University of Athens","startDate":"2025-02","conditions":["Corneal Epithelial Wound Healing"],"enrollment":68,"completionDate":"2026-01"},{"nctId":"NCT03461354","phase":"NA","title":"MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer","status":"TERMINATED","sponsor":"Wake Forest University Health Sciences","startDate":"2018-04-09","conditions":["Mucositis Oral","Head and Neck Cancer"],"enrollment":49,"completionDate":"2024-04-01"},{"nctId":"NCT06210373","phase":"NA","title":"Assessment of Efficacy and Safety of the Use of Two Eye Gel Products Containing 5% Dexpanthenol in Patients With Moderate to Severe Dry Eye Syndrome","status":"UNKNOWN","sponsor":"Fidia Farmaceutici s.p.a.","startDate":"2022-11-16","conditions":["Dry Eye Disease"],"enrollment":124,"completionDate":"2024-12"},{"nctId":"NCT05937529","phase":"NA","title":"Impact of Madecassoside and 5 % Panthenol Cream in Post Photodynamic Therapy for Actinic Keratosis","status":"COMPLETED","sponsor":"Merete Haedersdal","startDate":"2023-09-27","conditions":["Actinic Keratoses"],"enrollment":20,"completionDate":"2024-02-29"},{"nctId":"NCT06125730","phase":"NA","title":"A Single-Group Study to Evaluate the Effects of an Eyelash Serum on Improving Eyelash Growth","status":"COMPLETED","sponsor":"Dime Beauty Co.","startDate":"2023-08-23","conditions":["Eyelash Growth"],"enrollment":35,"completionDate":"2024-02-10"},{"nctId":"NCT06143033","phase":"NA","title":"A Clinical Trial to Evaluate the Effects of an Eye Serum on Improving the Appearance of the Periorbital Area","status":"COMPLETED","sponsor":"Dime Beauty Co.","startDate":"2023-08-21","conditions":["Periorbital Area"],"enrollment":35,"completionDate":"2024-02-15"},{"nctId":"NCT05699122","phase":"NA","title":"Use of Low-level Laser Therapy in the Treatment of Incontinence-associated Dermatitis in the Elderly","status":"COMPLETED","sponsor":"Hospital Israelita Albert Einstein","startDate":"2023-02-01","conditions":["Dermatitis"],"enrollment":16,"completionDate":"2023-06-30"},{"nctId":"NCT05588973","phase":"NA","title":"Prevention of Radiodermatitis in Breast and Head and Neck Cancer Patients in Cyprus","status":"UNKNOWN","sponsor":"Angelos Kassianos","startDate":"2022-12","conditions":["Head and Neck Cancer","Breast Cancer"],"enrollment":100,"completionDate":"2023-06"},{"nctId":"NCT04219358","phase":"PHASE1","title":"Topical Application of Imiquimod Gel at Different Concentrations in Actinic Cheilitis","status":"TERMINATED","sponsor":"Hospital de Clinicas de Porto Alegre","startDate":"2019-03-23","conditions":["Actinic Cheilitis"],"enrollment":49,"completionDate":"2021-08-24"},{"nctId":"NCT04016025","phase":"PHASE4","title":"A Clinical Study of Adherence to Methylprednisolone Aceponate in Different Carriers","status":"COMPLETED","sponsor":"Jena University Hospital","startDate":"2020-12-02","conditions":["Adherence, Patient","Chronic Eczema"],"enrollment":80,"completionDate":"2022-04-14"},{"nctId":"NCT04884464","phase":"","title":"Hyaluronic Acid in Counteracting Aphthous Stomatitis","status":"COMPLETED","sponsor":"University of Urbino \"Carlo Bo\"","startDate":"2018-09-01","conditions":["Aphthous Stomatitis"],"enrollment":49,"completionDate":"2019-06-30"},{"nctId":"NCT04872946","phase":"NA","title":"Topical and Oral Regimen for Skin Health","status":"COMPLETED","sponsor":"Integrative Skin Science and Research","startDate":"2019-11-26","conditions":["Skin Abnormalities"],"enrollment":74,"completionDate":"2020-05-07"},{"nctId":"NCT04835259","phase":"NA","title":"Efficacy of Topical Antioxidants in Tretment of Photoaging","status":"UNKNOWN","sponsor":"Sohag University","startDate":"2021-04","conditions":["Photoaging"],"enrollment":90,"completionDate":"2022-06"},{"nctId":"NCT03852563","phase":"NA","title":"A Study to Gain Information How Well Dexpanthenol Derma Cream Helps the Face Skin to Recover After Cosmetic Lasering","status":"COMPLETED","sponsor":"Bayer","startDate":"2019-03-18","conditions":["Erythema","Skin Recovery"],"enrollment":33,"completionDate":"2019-04-22"},{"nctId":"NCT03853525","phase":"PHASE4","title":"A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Skin to Recover After Laser Hair Removal in the Groin and Intimate Area","status":"COMPLETED","sponsor":"Bayer","startDate":"2019-02-11","conditions":["Skin Recovery"],"enrollment":35,"completionDate":"2019-03-11"},{"nctId":"NCT03853512","phase":"PHASE4","title":"A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Skin to Recover After a Peeling in the External Genital Area of Women","status":"COMPLETED","sponsor":"Bayer","startDate":"2019-02-12","conditions":["Skin Recovery"],"enrollment":33,"completionDate":"2019-03-13"},{"nctId":"NCT03853538","phase":"PHASE4","title":"A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Face Skin to Recover After Cosmetic Lasering","status":"COMPLETED","sponsor":"Bayer","startDate":"2019-01-28","conditions":["Erythema","Skin Recovery"],"enrollment":33,"completionDate":"2019-03-06"},{"nctId":"NCT02601235","phase":"PHASE3","title":"Efficacy and Safety of Pediatric Drugs in Nasal Congestion","status":"COMPLETED","sponsor":"EMS","startDate":"2018-01-16","conditions":["Nasal Congestion"],"enrollment":292,"completionDate":"2019-04-03"},{"nctId":"NCT03520348","phase":"PHASE1","title":"Safety and Tolerability of the Ophthalmic Gel PRO-167 Versus Corneregel® on Healthy Subjects.","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2017-10-04","conditions":["Dry Eye","Dry Eye Syndrome of Unspecified Lacrimal Gland"],"enrollment":24,"completionDate":"2018-07-16"},{"nctId":"NCT03866447","phase":"PHASE4","title":"Role of Vitamin D and Its Topical Analogues in Pathogenesis and Treatment of Acne Vulgaris","status":"UNKNOWN","sponsor":"Assiut University","startDate":"2019-10-01","conditions":["Acne Vulgaris"],"enrollment":80,"completionDate":"2021-03-01"},{"nctId":"NCT01533220","phase":"PHASE3","title":"Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal","status":"COMPLETED","sponsor":"EMS","startDate":"2013-01-01","conditions":["Flu","Cold","Allergic Disorder of Respiratory System"],"enrollment":132,"completionDate":"2014-04-30"},{"nctId":"NCT03439436","phase":"PHASE3","title":"A Study to Compare Two Formulations of Xylometazoline/Dexpanthenol Nasal Spray for the Treatment of Nasal Congestion.","status":"COMPLETED","sponsor":"McNeil AB","startDate":"2018-02-26","conditions":["Nasal Congestion"],"enrollment":140,"completionDate":"2018-05-02"},{"nctId":"NCT00771615","phase":"PHASE2","title":"Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged 18-64 Years","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-10-16","conditions":["Influenza"],"enrollment":469,"completionDate":"2009-12-04"},{"nctId":"NCT00693654","phase":"PHASE4","title":"Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients","status":"COMPLETED","sponsor":"Wake Forest University","startDate":"2006-11","conditions":["Pruritis"],"enrollment":28,"completionDate":"2008-10"},{"nctId":"NCT03611283","phase":"NA","title":"Topical Management of Xerostomia With Dry Mouth Products","status":"COMPLETED","sponsor":"Rosa María López-Pintor Muñoz","startDate":"2016-10-03","conditions":["Xerostomia","Sjogren's Syndrome"],"enrollment":28,"completionDate":"2017-11-30"},{"nctId":"NCT03095872","phase":"PHASE3","title":"Comparison of the Effect of Vaseline and Bepanthen® \"Wund- Und Heilsalbe\" on the Wound Healing Following Laser Therapy","status":"COMPLETED","sponsor":"RWTH Aachen University","startDate":"2017-03-01","conditions":["Photodamaged Skin"],"enrollment":37,"completionDate":"2018-02-05"},{"nctId":"NCT01136005","phase":"PHASE3","title":"Bepanthen Versus Cetomacrogol in Epidermal Growth Factor Receptor Inhibitors (EGFRI)","status":"COMPLETED","sponsor":"Impaqtt Foundation","startDate":"2010-09","conditions":["Cancer","Skin Rash"],"enrollment":160,"completionDate":"2017-03"},{"nctId":"NCT01693159","phase":"NA","title":"Effects of ECA on Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades","status":"UNKNOWN","sponsor":"National Center for Tumor Diseases, Heidelberg","startDate":"2011-05","conditions":["Pain"],"enrollment":50,"completionDate":"2018-11"},{"nctId":"NCT02615561","phase":"NA","title":"Curing Atopic Dermatits in Children With a Commerical Medical Device and Maintaining Healthy Skin by Using a New Cosmetic Product","status":"COMPLETED","sponsor":"Bayer","startDate":"2015-12-15","conditions":["Dermatitis, Atopic"],"enrollment":136,"completionDate":"2016-09-07"},{"nctId":"NCT03117153","phase":"NA","title":"Effect of a Liquid Toothpaste on Periodontal Disease","status":"COMPLETED","sponsor":"Dong-A Pharmaceutical","startDate":"2014-08-04","conditions":["Periodontitis","Gingivitis"],"enrollment":98,"completionDate":"2015-02-11"},{"nctId":"NCT02348242","phase":"NA","title":"Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study of Three Preventive Approaches","status":"COMPLETED","sponsor":"Fondation Ophtalmologique Adolphe de Rothschild","startDate":"2014-12","conditions":["Corneal Diseases"],"enrollment":49,"completionDate":"2016-02"},{"nctId":"NCT00661102","phase":"PHASE3","title":"A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine).","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2008-12","conditions":["Breast Cancer"],"enrollment":598,"completionDate":"2011-04"},{"nctId":"NCT02734628","phase":"PHASE4","title":"Pilot Study to Assess Number of Patients for Main Trial","status":"COMPLETED","sponsor":"Bayer","startDate":"2007-03","conditions":["Wound Healing"],"enrollment":28,"completionDate":"2007-04"},{"nctId":"NCT02379468","phase":"PHASE3","title":"Efficacy & Safety of Pedyphar Ointment in Diabetic Foot Ulcer Treatment","status":"COMPLETED","sponsor":"European Egyptian Pharmaceutical Industries","startDate":"2013-04","conditions":["Diabetic Foot Ulcer"],"enrollment":80,"completionDate":"2014-10"},{"nctId":"NCT01531517","phase":"PHASE3","title":"Study of the Efficacy of PedyPhar® Ointment on the Diabetic Foot Ulcers","status":"TERMINATED","sponsor":"European Egyptian Pharmaceutical Industries","startDate":"2011-07","conditions":["Diabetic Foot Ulcer"],"enrollment":47,"completionDate":"2013-07"},{"nctId":"NCT00859196","phase":"PHASE4","title":"Study to Assess on a Molecular Level the Influence of a 5 % Dexpanthenol Ointment in Subjects With Superficial Injuries","status":"COMPLETED","sponsor":"Bayer","startDate":"2009-02","conditions":["Wound Healing","Cell Proliferation","Gene Expression"],"enrollment":15,"completionDate":"2009-03"},{"nctId":"NCT00839280","phase":"PHASE2","title":"Moisturizing Effect of Two Dexpanthenol Formulations","status":"COMPLETED","sponsor":"Bayer","startDate":"2007-08","conditions":["Skin Abnormalities"],"enrollment":19,"completionDate":"2007-09"},{"nctId":"NCT01898182","phase":"PHASE4","title":"Efficacy and Safety of Kinetin 0.1% for Treatment of Skin Photoaging","status":"COMPLETED","sponsor":"Makati Medical Center","startDate":"2013-11","conditions":["Cutaneous Photoaging"],"enrollment":132,"completionDate":"2014-09"},{"nctId":"NCT00885937","phase":"PHASE1","title":"Comparative Safety Study of New Sinecort Formulation Versus Positive Control","status":"COMPLETED","sponsor":"Bayer","startDate":"2009-04","conditions":["Healthy"],"enrollment":33,"completionDate":"2009-05"},{"nctId":"NCT00839462","phase":"PHASE2","title":"Efficacy of Dexpanthenol in Thermic Erythema","status":"COMPLETED","sponsor":"Bayer","startDate":"2007-09","conditions":["Erythema"],"enrollment":55,"completionDate":"2007-09"},{"nctId":"NCT01858584","phase":"NA","title":"Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate","status":"UNKNOWN","sponsor":"Federico II University","startDate":"2013-02","conditions":["Gastroesophageal Reflux","Regurgitation","Vomiting","Chronic Cough"],"enrollment":75,"completionDate":""},{"nctId":"NCT01008813","phase":"PHASE2","title":"Clinical Trial to Evaluate the Immunogenicity and Safety of an Adjuvanted A(H1N1)v Influenza Vaccine and a Non-adjuvanted A(H1N1)v Influenza Vaccine in HIV-infected Patients (ANRS 151 Hifluvac)","status":"COMPLETED","sponsor":"French National Agency for Research on AIDS and Viral Hepatitis","startDate":"2009-10","conditions":["HIV Infections"],"enrollment":306,"completionDate":"2010-12"},{"nctId":"NCT01318889","phase":"PHASE2","title":"Dexpanthenol Mouthwash to Treat Oral Mucositis","status":"UNKNOWN","sponsor":"Shahid Beheshti University of Medical Sciences","startDate":"2010-09","conditions":["Oral Mucositis (Ulcerative) Due to Radiation"],"enrollment":30,"completionDate":"2011-09"},{"nctId":"NCT00876642","phase":"PHASE3","title":"Trial Comparing Best Supportive Care to Aloe Vera Gel","status":"COMPLETED","sponsor":"Marilia Medicine School","startDate":"2007-03","conditions":["Radiation Dermatitis"],"enrollment":137,"completionDate":"2008-12"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Intravenous","formulation":"Cream, Gel, Injection, Liquid","formulations":[{"form":"CREAM","route":"TOPICAL","productName":"Derma Hand Repair"},{"form":"GEL","route":"TOPICAL","productName":"Derma Charcoal Mask"},{"form":"INJECTION","route":"INTRAMUSCULAR","productName":"B-Combo"},{"form":"INJECTION","route":"INTRAMUSCULAR","productName":"Lipovite"},{"form":"INJECTION","route":"INTRAVENOUS","productName":"Vitamin B Complex"},{"form":"INJECTION","route":"INTRAVENOUS","productName":"VITAMIN B COMPLEX"},{"form":"INJECTION, SOLUTION","route":"INTRAMUSCULAR","productName":"B-PLEX 100"},{"form":"INJECTION, SOLUTION","route":"INTRAMUSCULAR","productName":"Vitamin B Complex"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Adult Infuvite Multiple Vitamins"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Adult Infuvite Multiple Vitamins for Infusion"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Infuvite Adult Multiple Vitamins"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSION"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Pediatric Infuvite Multiple Vitamins"},{"form":"LIQUID","route":"TOPICAL","productName":"Dr. SEED Black Bean Vegan Anti Hairloss Scalp Tonic"},{"form":"LIQUID","route":"TOPICAL","productName":"YOZUM WELL BEING HAIR COLOR"}]},"crossReferences":{"NUI":"N0000146036","MMSL":"1536","NDDF":"001696","UNII":"1O6C93RI7Z","VUID":"4020828","CHEBI":"CHEBI:27373","VANDF":"4017657","INN_ID":"1023","RXNORM":"22701","UMLSCUI":"C0057610","chemblId":"CHEMBL1200979","ChEMBL_ID":"CHEMBL1200979","DRUGBANK_ID":"DB09357","PUBCHEM_CID":"131204","SNOMEDCT_US":"126226000","MESH_SUPPLEMENTAL_RECORD_UI":"C007288"},"formularyStatus":[],"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"1953-","companyName":"Pfizer","relationship":"Original Developer"}],"publicationCount":308,"therapeuticAreas":["Immunology"],"atcClassification":{"source":"DrugCentral","atcCode":"A11HA30","allCodes":["A11HA30","D03AX03","S01XA12"]},"biosimilarFilings":[],"originalDeveloper":"Hospira","recentPublications":[{"date":"2026 Mar 5","pmid":"41901271","title":"Preparation and Investigation of Artemisia annua L.-Loaded Alginate Hydrogels with Excipients.","journal":"Pharmaceuticals (Basel, Switzerland)"},{"date":"2026 Feb 28","pmid":"41775114","title":"Translational framework combining machine learning and in vivo screening for aminoglycoside ototoxicity prevention.","journal":"Hearing research"},{"date":"2026 Feb 12","pmid":"41680294","title":"Dexpanthenol mitigates trauma-induced lung injury by modulating RIPK1/RIPK3/MLKL-mediated necroptosis in rats.","journal":"Scientific reports"},{"date":"2026 Jan 21","pmid":"41566030","title":"Effect of preoperative topical dexpanthenol moisturizer on the prevention of angular cheilitis after pediatric adenotonsillectomy: a prospective randomized controlled trial.","journal":"European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery"},{"date":"2026 Jun","pmid":"41531936","title":"3D printed system using ex vivo porcine eye globes to investigate intracorneal absorption of dexpanthenol from contact lens care solution and eye drops.","journal":"International journal of pharmaceutics: X"}],"combinationProducts":[{"brandName":"Adult Infuvite Multiple Vitamins","ingredients":"alpha-tocopherol acetate + ascorbic acid + biotin + colecalciferol + cyanocobalamin + dexpanthenol + folic acid + nicotinamide + phytomenadione + pyridoxine + thiamine + vitamin A palmitate"},{"brandName":"Adult Infuvite Multiple Vitamins for Infusion","ingredients":"alpha-tocopherol acetate + ascorbic acid + biotin + colecalciferol + cyanocobalamin + dexpanthenol + folic acid + nicotinamide + phytomenadione + pyridoxine + thiamine + vitamin A palmitate"},{"brandName":"Infuvite Adult Multiple Vitamins","ingredients":"alpha-tocopherol acetate + ascorbic acid + biotin + colecalciferol + cyanocobalamin + dexpanthenol + folic acid + nicotinamide + phytomenadione + pyridoxine + thiamine + vitamin A palmitate"},{"brandName":"PEDIATRIC INFUVITE MULTIPLE VITAMINS FOR INFUSION","ingredients":"alpha-tocopherol acetate + ascorbic acid + biotin + colecalciferol + cyanocobalamin + dexpanthenol + folic acid + nicotinamide + phytomenadione + pyridoxine + thiamine + vitamin A palmitate"},{"brandName":"Pediatric Infuvite Multiple Vitamins","ingredients":"alpha-tocopherol acetate + ascorbic acid + biotin + colecalciferol + cyanocobalamin + dexpanthenol + folic acid + nicotinamide + phytomenadione + pyridoxine + thiamine + vitamin A palmitate"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","companyName":"Pfizer","companyId":"pfizer","modality":"Small molecule","firstApprovalDate":"1953","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1953-02-20T00:00:00.000Z","mah":"HOSPIRA","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"BR","regulator":"ANVISA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MX","regulator":"COFEPRIS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AR","regulator":"ANMAT","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TR","regulator":"TITCK","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IN","regulator":"CDSCO","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TH","regulator":"FDA-TH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MY","regulator":"NPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"PH","regulator":"FDA-PH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CO","regulator":"INVIMA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"ZA","regulator":"SAHPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TW","regulator":"TFDA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"HK","regulator":"DH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T02:07:11.360198+00:00","fieldsConflicting":16,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}