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ACTHAR Gel (ACTH)
ACTHAR Gel (ACTH) is a ACTH analog Small molecule drug developed by University of Colorado, Denver. It is currently FDA-approved for Infantile spasms (West syndrome), Rheumatoid arthritis, Systemic lupus erythematosus. Also known as: ACTH.
ACTHAR Gel is a synthetic adrenocorticotropic hormone (ACTH) that stimulates the adrenal cortex to produce and release cortisol and other corticosteroids.
ACTHAR Gel is a synthetic adrenocorticotropic hormone (ACTH) 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 | ACTHAR Gel (ACTH) |
|---|---|
| Also known as | ACTH |
| Sponsor | University of Colorado, Denver |
| Drug class | ACTH analog |
| Target | Melanocortin-2 receptor (MC2R) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
ACTHAR binds to melanocortin-2 receptors on adrenocortical cells, triggering the release of endogenous glucocorticoids and mineralocorticoids. This endogenous steroid production provides anti-inflammatory and immunosuppressive effects. Unlike exogenous corticosteroids, ACTHAR stimulates the body's own steroid synthesis, which may offer different pharmacodynamic properties and potentially preserve adrenal function.
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
- Mood changes (irritability, anxiety)
- Insomnia
- Acne
- Increased infection risk
Key clinical trials
- ACTH as A Re-emerging theRapy for Uveitis (The ACTHAR Study) (PHASE2)
- 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)
- A Study of SNP-ACTH (1-39) Gel in Patients With Primary Membranous Nephropathy (PHASE3)
- The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis (PHASE3)
- Ocular Sarcoidosis Open Label Trial of ACTHAR Gel (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:
- ACTHAR Gel (ACTH) CI brief — competitive landscape report
- ACTHAR Gel (ACTH) updates RSS · CI watch RSS
- University of Colorado, Denver portfolio CI
Frequently asked questions about ACTHAR Gel (ACTH)
What is ACTHAR Gel (ACTH)?
How does ACTHAR Gel (ACTH) work?
What is ACTHAR Gel (ACTH) used for?
Who makes ACTHAR Gel (ACTH)?
Is ACTHAR Gel (ACTH) also known as anything else?
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What does ACTHAR Gel (ACTH) target?
Related
- Drug class: All ACTH analog drugs
- Target: All drugs targeting Melanocortin-2 receptor (MC2R)
- Manufacturer: University of Colorado, Denver — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Infantile spasms (West syndrome)
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Systemic lupus erythematosus
- Also known as: ACTH
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing