Corticotropin is an adrenocorticotropic hormone indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age, among other approved uses. It is available as injection for subcutaneous and intramuscular use. MedsAcross supplies Corticotropin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age. Acthar Gel is indicated for the treatment of exacerbations of multiple sclerosis in adults. Acthar Gel may be used for the following disorders and diseases: rheumatic, collagen, dermatologic, allergic states, ophthalmic, respiratory, and edematous state.
Source: US FDA prescribing information
The mechanism of action of Acthar Gel in the treatment of infantile spasms is unknown. Acthar Gel and endogenous ACTH stimulate the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances. Prolonged administration of large doses of Acthar Gel induces hyperplasia and hypertrophy of the adrenal cortex and continuous high output of cortisol, corticosterone and weak androgens. The release of endogenous ACTH is under the influence of the nervous system via the regulatory hormone released from the hypothalamus and by a negative corticosteroid feedback mechanism. Elevated plasma cortisol suppresses ACTH release. Acthar Gel is also reported to bind to melanocortin receptors. The trophic effects of endogenous ACTH and Acthar Gel on the adrenal cortex are not well understood beyond the fact that they appear to be mediated by cyclic AMP.
Source: US FDA prescribing information
Acthar Gel vial is for either intramuscular or subcutaneous injection. Acthar Gel single-dose pre-filled SelfJect injector: is for subcutaneous administration by adults only. used to administer single doses of 40 units or 80 units only. Infantile spasms: doses must be administered intramuscularly using the Acthar gel vial. The recommended dose is 150 U/m 2 divided into twice daily injections of 75 U/m 2. After 2 weeks of treatment dosing should be gradually tapered and discontinued over a 2-week period. Acthar Gel single-dose pre-filled SelfJect injector is not to be used for the treatment of infantile spasms. Acute exacerbations of multiple sclerosis: daily intramuscular or subcutaneous doses of 80 to 120 units for 2-3 weeks may be administered. It may be necessary to taper the dose. Other disorders and diseases: individualize dosing depending on the disease and patient.
Source: US FDA prescribing information
Acthar Gel is contraindicated: for intravenous administration. in infants under 2 years of age who have suspected congenital infections. with concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar Gel. in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, or adrenocortical hyperfunction. in patients with a history of hypersensitivity reaction to corticotropin or any of the inactive ingredients of Acthar Gel or sensitivity to proteins of porcine origin.
Source: US FDA prescribing information
The adverse effects of Acthar Gel are related primarily to its steroidogenic effects. Not all of the adverse events described below have been seen after treatment with Acthar Gel, but they might be expected to occur because they are steroidogenic effects. Infections: Increased susceptibility to new infection and increased risk of exacerbation, dissemination or reactivation of latent infections. Signs and symptoms of infection may be masked. Adrenal Insufficiency after Prolonged Therapy: Monitor for effects of hypothalamic-pituitary-adrenal axis suppression after stopping treatment. Cushing's Syndrome: May occur after prolonged therapy. Monitor for signs and symptoms. Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia: Monitor blood pressure and sodium and potassium levels.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Infections Cushing's Syndrome and Adrenal Insufficiency Upon Withdrawal Elevated Blood Pressure, Salt and Water Retention, and Hypokalemia Masking Symptoms of Other Diseases Gastrointestinal Perforation and Bleeding Behavioral and Mood Disturbances Ophthalmic Effects Immunogenicity Potential and Hypersensitivity Negative Effects on Growth and Physical Development Decrease in Bone Density Commonly reported postmarketing adverse reactions for Acthar Gel include injection site reaction, asthenic conditions (including fatigue, malaise, asthenia and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and blood glucose increased.
Source: US FDA prescribing information
Formal drug-drug interaction studies have not been performed. Acthar Gel may accentuate the electrolyte loss associated with diuretic therapy. Acthar Gel may accentuate electrolyte loss associated with diuretics.
Source: US FDA prescribing information
Store Acthar Gel vial and Acthar Gel single-dose pre-filled SelfJect injector under refrigeration between 2°C to 8°C (36°F to 46°F) in the carton to protect from light. After removing the single-dose pre-filled SelfJect injector from the refrigerator, it can be stored at room temperature between 20°C to 25°C (68°F to 77°F) for up to 24 hours. Do not heat, freeze, or put the Acthar Gel single-dose pre-filled SelfJect injector into direct sunlight.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Corticotropin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Acthar 40 units/0.5 mL injectionSubcutaneous Cold chain | Keenova ARD | US FDA | Available on request |
| Purified Cortrophin Gel 80 units/mL injectionIntramuscular, subcutaneous Cold chain | ANI Pharmaceuticals | US FDA | Available on request |
| Purified Cortrophin Gel 80 units/mL injectionSubcutaneous Cold chain | ANI Pharmaceuticals | US FDA | Available on request |
| Acthar 80 units/mL injectionIntramuscular, subcutaneous Cold chain | Keenova ARD | US FDA | Available on request |
2 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 3 July 1950 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Corticotropin in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 4 presentations of Corticotropin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Corticotropin, including Acthar, Purified Cortrophin Gel.
Yes. The US FDA first approved Corticotropin on 3 July 1950, according to Drugs@FDA.
At least one listed presentation of Corticotropin must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Corticotropin is classified under ATC code H01AA01 (Corticotropin).
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