{"id":"h-p-acthar-subcutaneous-gel-injection","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypertension"},{"rate":null,"effect":"Hyperglycemia / glucose intolerance"},{"rate":null,"effect":"Hypokalemia"},{"rate":null,"effect":"Fluid retention / edema"},{"rate":null,"effect":"Mood changes / psychiatric effects"},{"rate":null,"effect":"Insomnia"},{"rate":null,"effect":"Injection site reactions"}]},"_chembl":{"chemblId":"CHEMBL1201610","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Acthar binds to melanocortin receptors on adrenocortical cells, triggering release of cortisol and other adrenal hormones. Beyond this indirect corticosteroid effect, it also exerts direct anti-inflammatory and immunomodulatory actions through melanocortin receptors on immune cells, making it distinct from exogenous corticosteroid therapy.","oneSentence":"H.P. Acthar is a corticotropin (ACTH) analog that stimulates the adrenal cortex to produce endogenous corticosteroids and has direct immunomodulatory effects.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:40:00.998Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Uveitis (including non-infectious uveitis)"},{"name":"Infantile spasms (West syndrome)"},{"name":"Multiple sclerosis relapse"},{"name":"Systemic lupus erythematosus"},{"name":"Rheumatoid arthritis"}]},"trialDetails":[{"nctId":"NCT02245841","phase":"PHASE4","title":"Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis","status":"COMPLETED","sponsor":"The Cleveland Clinic","startDate":"2015-06-15","conditions":"Dermatomyositis, Juvenile Dermatomyositis","enrollment":19},{"nctId":"NCT03727776","phase":"EARLY_PHASE1","title":"Adrenocorticotropic Hormone (ACTH) for Post-op Inflammation in Proliferative Vitreoretinopathy (PVR)","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2019-08-19","conditions":"Proliferative Vitreoretinopathy","enrollment":11},{"nctId":"NCT03320070","phase":"PHASE4","title":"Acthar Gel in Participants With Pulmonary Sarcoidosis","status":"COMPLETED","sponsor":"Mallinckrodt","startDate":"2018-02-21","conditions":"Sarcoidosis, Pulmonary","enrollment":55},{"nctId":"NCT03068754","phase":"PHASE2, PHASE3","title":"Study of Acthar® Gel (Acthar) for Amyotrophic Lateral Sclerosis (ALS)","status":"TERMINATED","sponsor":"Mallinckrodt","startDate":"2017-06-22","conditions":"Amyotrophic Lateral Sclerosis","enrollment":143},{"nctId":"NCT02919761","phase":"PHASE4","title":"Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis","status":"COMPLETED","sponsor":"Mallinckrodt","startDate":"2016-11-07","conditions":"Arthritis, Rheumatoid","enrollment":259},{"nctId":"NCT01753401","phase":"PHASE4","title":"Acthar for the Treatment of Systemic Lupus Erythematosus (SLE) in Patients With a History of Persistently Active Disease","status":"COMPLETED","sponsor":"Mallinckrodt","startDate":"2013-01","conditions":"Systemic Lupus Erythematosus (SLE)","enrollment":38},{"nctId":"NCT02764697","phase":"PHASE4","title":"Study of H.P. ACTHAR Subcutaneous Gelatin (Gel)(Highly Purified Gel Injection) in Uveitis Patients","status":"COMPLETED","sponsor":"Tampa Bay Uveitis Center, LLC","startDate":"2016-06-30","conditions":"Uveitis, Anterior Uveitis, Intermediate Uveitis","enrollment":6},{"nctId":"NCT01888354","phase":"PHASE4","title":"Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ)Versus ACTHar Gel Five Days SQ for the Treatment of MS Exacerbations","status":"COMPLETED","sponsor":"The University of Texas Health Science Center, Houston","startDate":"2013-04","conditions":"Multiple Sclerosis (MS)","enrollment":25},{"nctId":"NCT01906684","phase":"NA","title":"Comprehensive Analysis of Relapse in Multiple Sclerosis","status":"UNKNOWN","sponsor":"Tanner Foundation for Multiple Sclerosis","startDate":"2013-08","conditions":"Multiple Sclerosis","enrollment":20},{"nctId":"NCT01769937","phase":"PHASE4","title":"Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus","status":"COMPLETED","sponsor":"Fiechtner, Justus J., M.D., P.C.","startDate":"2012-10","conditions":"Lupus Erythematosus Systemic Exacerbation","enrollment":10}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Acthar"],"phase":"marketed","status":"active","brandName":"H.P. ACTHAR SUBCUTANEOUS GEL INJECTION","genericName":"H.P. ACTHAR SUBCUTANEOUS GEL INJECTION","companyName":"Tampa Bay Uveitis Center, LLC","companyId":"tampa-bay-uveitis-center-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"H.P. Acthar is a corticotropin (ACTH) analog that stimulates the adrenal cortex to produce endogenous corticosteroids and has direct immunomodulatory effects. Used for Uveitis (including non-infectious uveitis), Infantile spasms (West syndrome), Multiple sclerosis relapse.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}