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vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Petechiae and ecchymoses","drugRate":"","severity":"common","organSystem":""},{"effect":"Thin fragile skin","drugRate":"","severity":"common","organSystem":""},{"effect":"Decreased carbohydrate tolerance","drugRate":"","severity":"common","organSystem":""},{"effect":"Vertigo","drugRate":"","severity":"common","organSystem":""}],"specialPopulations":{"Lactation":"There are no available data on the presence of corticotropin in either human or animal milk, the effects on the breastfed infant, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Acthar Gel and any potential adverse effects on the breastfed infant from Acthar Gel or from the underlying maternal condition.","Pregnancy":"May cause fetal harm. Infants born of mothers who have received substantial doses of corticotropin during pregnancy should be carefully observed for signs of hypoadrenalism. The potential benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus.","Paediatric use":"Prolonged use of Acthar Gel in children may inhibit skeletal growth. If use is necessary, it should be given intermittently with careful observation. Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children less than 2 years of age."},"seriousAdverseEvents":[{"effect":"Anaphylaxis","drugRate":"","severity":"serious"},{"effect":"Peptic ulcer with possible perforation and hemorrhage","drugRate":"","severity":"serious"},{"effect":"Convulsions","drugRate":"","severity":"serious"},{"effect":"Congestive heart failure","drugRate":"","severity":"serious"},{"effect":"Aseptic necrosis of femoral and humeral heads","drugRate":"","severity":"serious"},{"effect":"Glaucoma with possible damage to optic nerve","drugRate":"","severity":"serious"},{"effect":"Increased intracranial pressure with papilledema","drugRate":"","severity":"serious"},{"effect":"Pancreatitis","drugRate":"","severity":"serious"},{"effect":"Necrotizing angiitis","drugRate":"","severity":"serious"},{"effect":"Secondary adrenocortical and pituitary 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GEL","expiryDate":"2043-10-27"},{"type":"Formulation","number":"12324787","applicant":"ANI PHARMACEUTICALS INC","territory":"US","tradeName":"PURIFIED CORTROPHIN GEL","expiryDate":"2043-10-27"}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CORTICOTROPIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:27:01.463437+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:27:01.463366+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:27:07.172656+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:27:00.526715+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CORTICOTROPIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:27:07.504261+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":"2026-04-20T00:26:57.337285+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:26:57.337307+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed 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It is a small molecule adrenocorticotropic hormone (ACTH) that targets the melanocyte-stimulating hormone receptor. Acthar Gel is FDA-approved for the treatment of exacerbation of multiple sclerosis, Stevens-Johnson syndrome, and West syndrome. It is off-patent and has a generic manufacturer. As an off-patent medication, Acthar Gel's commercial status is subject to market competition.","approvals":[{"date":"1950-07-03","orphan":false,"company":"SANOFI AVENTIS US","regulator":"FDA"}],"brandName":"Acthar Gel","ecosystem":[{"indication":"Exacerbation of multiple sclerosis","otherDrugs":[],"globalPrevalence":null},{"indication":"Stevens-Johnson syndrome","otherDrugs":[{"name":"prednisolone","slug":"prednisolone","company":""}],"globalPrevalence":null},{"indication":"West syndrome","otherDrugs":[{"name":"vigabatrin","slug":"vigabatrin","company":"Lundbeck Llc"}],"globalPrevalence":null}],"mechanism":{"target":"Melanocyte-stimulating hormone receptor","novelty":"First-in-class","targets":[{"gene":"MC1R","source":"DrugCentral","target":"Melanocyte-stimulating hormone receptor","protein":"Melanocyte-stimulating hormone receptor"},{"gene":"MC3R","source":"DrugCentral","target":"Melanocortin receptor 3","protein":"Melanocortin receptor 3"},{"gene":"MC4R","source":"DrugCentral","target":"Melanocortin receptor 4","protein":"Melanocortin receptor 4"},{"gene":"MC2R","source":"DrugCentral","target":"Adrenocorticotropic hormone receptor","protein":"Adrenocorticotropic hormone receptor"}],"modality":"Small Molecule","drugClass":"Adrenocorticotropic Hormone [EPC]","explanation":"","oneSentence":"","technicalDetail":"Acthar Gel is a synthetic form of adrenocorticotropic hormone (ACTH), a peptide hormone that stimulates the production of cortisol in the adrenal cortex. By binding to the melanocyte-stimulating hormone receptor, ACTH triggers a cascade of downstream effects that ultimately lead to the production of cortisol, which has anti-inflammatory and immunosuppressive properties."},"commercial":{"launchDate":"1950","_launchSource":"DrugCentral (FDA 1950-07-03, SANOFI AVENTIS US)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4931","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CORTICOTROPIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CORTICOTROPIN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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provided"}],"offLabel":[],"pipeline":[]},"currentOwner":"Mallinckrodt Ireland","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"tetracosactide","brandName":"tetracosactide","genericName":"tetracosactide","approvalYear":"1970","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT03708900","phase":"PHASE2","title":"Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome","status":"RECRUITING","sponsor":"RECORDATI GROUP","startDate":"2021-04-28","conditions":["Cushing Syndrome"],"enrollment":12,"completionDate":"2027-07-21"},{"nctId":"NCT02683889","phase":"PHASE3","title":"Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation","status":"COMPLETED","sponsor":"University of Colorado, 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Rouen","startDate":"2021-11-18","conditions":["ACTH"],"enrollment":10,"completionDate":"2021-11-18"},{"nctId":"NCT07350031","phase":"","title":"Serum and Salivary Cortisol Assessment in Patients With Adrenal Incidentalomas and Healthy Controls","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","startDate":"2016-11-24","conditions":["Adrenal Incidentaloma","Hypercortisolism"],"enrollment":209,"completionDate":"2024-04-26"},{"nctId":"NCT06344143","phase":"","title":"Detecting Mild Autonomous Cortisol Secretion in Patients With Adrenal Incidentaloma","status":"RECRUITING","sponsor":"The Cleveland Clinic","startDate":"2024-11-20","conditions":["Mild Autonomous Cortisol Secretion (MACS)"],"enrollment":20,"completionDate":"2030-12-31"},{"nctId":"NCT00227253","phase":"","title":"Chromosome 18 Clinical Research Center","status":"RECRUITING","sponsor":"The University of Texas Health Science Center at San Antonio","startDate":"1993-09","conditions":["Chromosome Aberrations","Growth 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