Last reviewed · How we verify
Open label 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 | Open label H.P. Acthar Gel |
|---|---|
| Also known as | ACTH |
| 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 / Neurology |
| Phase | FDA-approved |
Mechanism of action
Acthar contains purified 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
- Multiple sclerosis relapse
- Nephrotic syndrome
Common side effects
- Hypertension
- Hyperglycemia
- Hypokalemia
- Fluid retention
- Mood changes / psychiatric effects
- Insomnia
- Acne
- Injection site reactions
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)
- 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)
- Acthar Gel in Participants With Pulmonary Sarcoidosis (PHASE4)
- Impact of Acthar on Everyday Life of Participants With Severe Keratitis (PHASE4)
- Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer) (PHASE4)
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:
- Open label H.P. Acthar Gel CI brief — competitive landscape report
- Open label H.P. Acthar Gel updates RSS · CI watch RSS
- Fiechtner, Justus J., M.D., P.C. portfolio CI