Evidence Grade A — Regulatory approved. 20037 published studies. 186 registered clinical trials.
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Corticotropin (sold as Acthar Gel) is an injectable preparation of ACTH — a hormone that stimulates the adrenal glands to produce cortisol and other anti-inflammatory steroids. It carries approximately 19 labelled conditions including infantile spasms (a severe seizure disorder in babies), nephrotic syndrome, and multiple sclerosis relapses. It is also one of the most commercially controversial medications in the US due to extraordinary price increases over the past two decades.
Corticotropin is also known by these brand and alternate names:
20,037 published studies: 8327 human, 9255 animal, 1473 in-vitro, 2389 reviews
Corticotropin is marketed as H.P. Acthar Gel (currently ANI Pharmaceuticals). It carries approximately 19 FDA-labelled indications including infantile spasms (its strongest evidence base), nephrotic syndrome, multiple sclerosis relapses, and rheumatic disorders.
Acthar Gel has been at the centre of major pricing and legal controversies. The price rose from approximately $40 per vial in 2001 to over $40,000, driven by successive acquisitions and orphan-like positioning despite broad labelling. The former manufacturer Mallinckrodt agreed to a $260 million settlement over antitrust concerns. Clinically, the strongest evidence supports its use in infantile spasms, where it is considered a first-line treatment. For most other indications, debate continues over whether it offers meaningful advantages over far less expensive oral corticosteroids.
Corticotropin stimulates the adrenal glands to produce cortisol, the body's primary anti-inflammatory hormone, and other adrenal steroids. This is its traditional mechanism. However, corticotropin also activates melanocortin receptors beyond the adrenal glands, particularly on immune cells, which may produce anti-inflammatory and immunomodulatory effects independent of cortisol production. This additional mechanism has been proposed as a reason why Acthar Gel may have effects beyond what oral corticosteroids alone provide, though this remains debated.
The strongest evidence for corticotropin is in infantile spasms, where it is considered a first-line treatment. For most of its other labelled conditions, the evidence is weak by modern standards, and there is ongoing debate about whether it offers meaningful advantages over far less expensive oral corticosteroids. The drug's commercial history has overshadowed its clinical profile. The price rose from approximately $40 per vial in 2001 to over $38,000, driven by successive corporate acquisitions. The manufacturer at the time, Mallinckrodt, agreed to a major antitrust settlement over allegations of illegally acquiring a potential competing product. Medicare spending on Acthar reached billions of dollars. Proponents argue that ACTH has immunomodulatory effects beyond what oral steroids provide through additional melanocortin receptor activation, but this claim remains debated.
PeptideTrace tracks 186 registered clinical trials for Corticotropin sourced from ClinicalTrials.gov.
Combination Osilodrostat and Cabergoline in Cushing's Disease
FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
CRF2 Agonist for the Treatment of Worsening Heart Failure
AuriculoTherapy NeuroImaging
A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
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Corticotropin (H.P. Acthar Gel) is a purified preparation of adrenocorticotropic hormone (ACTH) derived from porcine pituitary glands, formulated in a repository gelatin vehicle for prolonged release after intramuscular or subcutaneous injection. Originally approved in 1952, it is one of the oldest biologic products on the US market.
Corticotropin activates the melanocortin-2 receptor (MC2R) on adrenal cortex cells, stimulating cortisol biosynthesis. Additionally, the full-length ACTH peptide and/or related pituitary peptides in the preparation activate melanocortin receptors MC1R, MC3R, MC4R, and MC5R on immune cells, producing direct immunomodulatory and anti-inflammatory effects that are proposed to be independent of steroidogenesis. This melanocortin receptor-mediated immunomodulation is cited as the mechanism distinguishing Acthar from exogenous corticosteroids, though this distinction remains scientifically debated.
Corticotropin is marketed as H.P. Acthar Gel (currently ANI Pharmaceuticals, formerly Mallinckrodt/Questcor). It carries approximately 19 FDA-labeled indications including infantile spasms (the primary high-evidence indication), nephrotic syndrome (proteinuria reduction in idiopathic nephrotic syndrome), multiple sclerosis exacerbations, rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, gout, and others. ANI Pharmaceuticals' Cortrophin Gel (approved November 1, 2021) provides the first FDA-approved alternative, priced at approximately 23% below Acthar.
Vancomycin is marketed as Vancocin and Firvanq (approved 1958, with oral solution Firvanq approved 2018). It is the standard treatment for serious MRSA infections (bloodstream infections, endocarditis, pneumonia, bone infections) and is first-line for severe C. difficile colitis. Vancomycin requires therapeutic drug monitoring — blood levels must be checked regularly to ensure the dose is effective without causing kidney damage or hearing loss. The rise of vancomycin-resistant enterococci (VRE) and occasional vancomycin-intermediate S. aureus (VISA) strains represent ongoing challenges. Despite being nearly 70 years old, vancomycin remains irreplaceable for many serious infections, though newer alternatives like daptomycin and the lipoglycopeptides offer advantages in specific settings.
Zilucoplan is marketed as Zilbrysq (approved October 2023) for anti-acetylcholine receptor antibody-positive generalised myasthenia gravis in adults. Administered as a daily subcutaneous self-injection. In the RAISE trial, zilucoplan showed statistically significant improvements in both activities of daily living and quantitative muscle strength scores compared to placebo, with improvements evident from week one. Its key differentiator from existing complement inhibitors (eculizumab, ravulizumab) is the self-injectable format — those alternatives require hospital-based intravenous infusions. As with all complement inhibitors, patients require meningococcal vaccination before starting treatment due to increased susceptibility to meningococcal infection.
Daptomycin is marketed as Cubicin (approved September 2003). It is indicated for complicated skin and soft tissue infections and S. aureus bloodstream infections including right-sided endocarditis. Administered as a once-daily intravenous infusion. A key limitation is that daptomycin cannot be used for pneumonia — lung surfactant inactivates the drug. In the bacteraemia trial, daptomycin was non-inferior to vancomycin with significantly lower rates of kidney problems (11% versus 26%). Creatine kinase (CK) levels must be monitored during treatment, as daptomycin can cause muscle toxicity. Generics became available after patent expiry, significantly reducing cost.
This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.
