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H.P. Acthar Gel
H.P. Acthar Gel is a corticotropin (ACTH) preparation that stimulates the adrenal cortex to produce and release cortisol and other corticosteroids.
H.P. Acthar Gel is a corticotropin (ACTH) preparation that stimulates the adrenal cortex to produce and release cortisol and other corticosteroids. Used for Infantile spasms (West syndrome), Rheumatoid arthritis, Systemic lupus erythematosus.
At a glance
| Generic name | H.P. Acthar Gel |
|---|---|
| Also known as | ACTH, Acthar, Repository Corticotropin Injection, ACTH Gel, Acthar Gel |
| Sponsor | Fiechtner, Justus J., M.D., P.C. |
| Drug class | Corticotropin (ACTH analog) |
| Target | Melanocortin-2 receptor (MC2R) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Rheumatology |
| Phase | FDA-approved |
Mechanism of action
Acthar contains adrenocorticotropic hormone (ACTH), which binds to melanocortin receptors on adrenocortical cells, triggering the synthesis and secretion of endogenous glucocorticoids and mineralocorticoids. This endogenous steroid production provides anti-inflammatory and immunosuppressive effects. Unlike exogenous corticosteroids, ACTH stimulates the adrenal gland directly, potentially offering a more physiologic hormonal response.
Approved indications
- Infantile spasms (West syndrome)
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Polymyositis and dermatomyositis
- Acute exacerbations of multiple sclerosis
- Nephrotic syndrome
Common side effects
- Hypertension
- Hyperglycemia
- Hypokalemia
- Fluid retention
- Mood changes / psychiatric effects
- Insomnia
- Increased infection risk
Key clinical trials
- Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease (PHASE4)
- ACTHar in the Treatment of Lupus Nephritis (PHASE4)
- ACTH in Progressive Forms of MS (PHASE2)
- Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis (PHASE4)
- The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis (PHASE3)
- Ocular Sarcoidosis Open Label Trial of ACTHAR Gel (NA)
- A Clinical Study to Evaluate the Potential Role of ACTH Gel in Patients With Scleritis (PHASE2)
- ACTH Gel Therapy in Rheumatoid Arthritis (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- H.P. Acthar Gel CI brief — competitive landscape report
- H.P. Acthar Gel updates RSS · CI watch RSS
- Fiechtner, Justus J., M.D., P.C. portfolio CI