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Acthar Gel 80 UNT/ML Injectable Solution
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), Nephrotic syndrome, Systemic lupus erythematosus.
At a glance
| Generic name | Acthar Gel 80 UNT/ML Injectable Solution |
|---|---|
| Also known as | Tacrolimus 1.0 mg, H.P. Acthar gel |
| Sponsor | NephroNet, Inc. |
| Drug class | Adrenocorticotropic hormone (ACTH) analog |
| Target | Melanocortin-2 receptor (MC2R) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Rheumatology / Nephrology |
| Phase | FDA-approved |
Mechanism of action
ACTH binds to melanocortin-2 receptors on adrenocortical cells, triggering a cascade that increases synthesis and secretion of endogenous glucocorticoids and mineralocorticoids. This endogenous steroid production provides anti-inflammatory and immunosuppressive effects. Unlike exogenous corticosteroids, ACTH stimulation may preserve some aspects of normal adrenal function and circadian rhythm.
Approved indications
- Infantile spasms (West syndrome)
- Nephrotic syndrome
- Systemic lupus erythematosus
- Rheumatoid arthritis
- Acute exacerbations of multiple sclerosis
Common side effects
- Hypertension
- Hyperglycemia
- Hypokalemia
- Mood changes / psychiatric effects
- Insomnia
- Acne
- Fluid retention / edema
- 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)
- A Study of Acthar Gel Alone or With Tacrolimus to Reduce Proteinuria in Fibrillary Glomerulopathy Patients (PHASE4)
- Comparative and Efficacy Study of ACTHar Gel Alone or in Combination With Tacrolimus in Fibrillary Glomerulopathy (PHASE4)
- ACTHAR Gel for Drug REsistant Nephrotic Syndrome in Children (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:
- Acthar Gel 80 UNT/ML Injectable Solution CI brief — competitive landscape report
- Acthar Gel 80 UNT/ML Injectable Solution updates RSS · CI watch RSS
- NephroNet, Inc. portfolio CI