H.P. ACTHAR GEL (repository corticotropin)
H.P. Acthar Gel is an adrenocorticotropic hormone indicated as monotherapy for the treatment of infantile spasms in infants and children under two years of age and for acute exacerbations of multiple sclerosis in adults. It is also indicated for the management of various rheumatic, collagen, dermatologic, allergic, ophthalmic, and respiratory diseases, often as adjunctive therapy for short-term administration or during acute exacerbations. Additionally, it is indicated for use in edematous states to induce diuresis or remission of proteinuria in nephrotic syndrome (without uremia).
How H.P. ACTHAR GEL Works
Acthar Gel stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and various weak androgenic substances. While its exact mechanism for treating infantile spasms remains unknown, the drug is reported to bind to melanocortin receptors. The resulting increase in plasma cortisol levels suppresses the release of endogenous adrenocorticotropic hormone (ACTH) through a negative feedback mechanism. These trophic effects on the adrenal cortex are mediated by cyclic AMP. Prolonged administration of high doses can induce adrenal hyperplasia and hypertrophy.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2010-10-15
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
H.P. ACTHAR GEL Approval History
What H.P. ACTHAR GEL Treats
8 indicationsH.P. ACTHAR GEL is approved for 8 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Infantile Spasms
- Multiple Sclerosis
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- Systemic Lupus Erythematosus
- Dermatomyositis
- Erythema Multiforme
H.P. ACTHAR GEL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in H.P. ACTHAR GEL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications H.P. ACTHAR GEL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to H.P. ACTHAR GEL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02298491 results posted | HP-00062490 | Ph 4 | completed | Treatment of CNS Sarcoidosis With H.P. Acthar Gel |
| NCT02245841 results posted | 14-1015 | Ph 4 | completed | Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis |
| NCT01813591 | ACTHAR | Ph 2 | completed | A Two-Arm Study Evaluation H.P. Acthar Injection Gel in Treatment of Chronic Migraines |
| NCT01155141 results posted | SU-08182009-3600 | Ph 4 | completed | Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH |
| NCT01769937 ACTH | 11191966 | Ph 4 | completed | Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
H.P. ACTHAR GEL FDA Label Details
Indications & Usage
FDA Label (PDF)H.P. ACTHAR GEL is indicated for the treatment of Infantile Spasms; Multiple Sclerosis; Psoriatic Arthritis; Rheumatoid Arthritis; Ankylosing Spondylitis; Systemic Lupus Erythematosus; Dermatomyositis; Erythema Multiforme.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment