Last reviewed 2026-04-20 · How we verify

Acthar Gel (CORTICOTROPIN)

Acthar Gel (CORTICOTROPIN) is a medication originally developed by Sanofi-Aventis US and currently owned by Mallinckrodt Ireland. 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.

At a glance

Approved indications

• Exacerbation of multiple sclerosis
• Stevens-Johnson syndrome
• West syndrome

Common side effects

• Hypokalemic alkalosis
• Sodium retention
• Fluid retention
• Muscle weakness
• Loss of muscle mass
• Osteoporosis
• Hypertension
• Headache
• Menstrual irregularities
• Development of Cushingoid state
• Increased sweating
• Acne

Serious adverse events

• Anaphylaxis
• Peptic ulcer with possible perforation and hemorrhage
• Convulsions
• Congestive heart failure
• Aseptic necrosis of femoral and humeral heads
• Glaucoma with possible damage to optic nerve
• Increased intracranial pressure with papilledema
• Pancreatitis
• Necrotizing angiitis
• Secondary adrenocortical and pituitary insufficiency

Key clinical trials

• Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome (PHASE2)
• Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation (PHASE3)
• FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease (EARLY_PHASE1)
• A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer (PHASE2)
• AuriculoTherapy NeuroImaging (NA)
• CRF2 Agonist for the Treatment of Worsening Heart Failure (PHASE2)
• Use of Acthar in Rheumatoid Arthritis (RA) Related Flares (PHASE4)
• ACTH Stability on Whole Blood (NA)

Patents

Primary sources

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