Corticotropin (ACTH)

Also known as: repository corticotropin · Acthar · Purified Cortrophin Gel

FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval FDA-approved 8 applications
Randomized controlled trials 66 of 2,569 publications on PubMed
Registered clinical trials 130 8 active
Adverse event reports 20,483 9,457 classified as serious
  • Corticotropin (ACTH) is an FDA-approved drug, marketed as Acthar, Purified, H.p. (first approval: April 29, 1952).
  • PubMed lists 2,569 publications mentioning it, including 66 randomized controlled trials and 506 animal-only studies.
  • ClinicalTrials.gov lists 130 registered studies testing it (8 active).
  • FDA's adverse event system (FAERS) holds 20,483 reports mentioning it; 9,457 classified as serious. Reports do not prove causation.

Research topics

  • Adrenocorticotropic Hormone 80
  • Spasms, Infantile 66
  • Anticonvulsants 38
  • Electroencephalography 26
  • Vigabatrin 20
  • Spasm 17
  • Adrenal Cortex Hormones 12
  • Prednisolone 12
  • Glucocorticoids 10
  • Gels 8

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
NDA007504 ACTHAR Approved, discontinued July 3, 1950 SANOFI AVENTIS US
NDA008317 ACTH Approved, discontinued March 14, 1952 PARKEDALE
NDA008372 ACTHAR GEL, ACTHAR GEL (AUTOINJECTOR) Approved, marketed April 29, 1952 MALLINCKRODT IRELAND
NDA008975 PURIFIED CORTROPHIN GEL Approved, marketed June 16, 1954 ANI PHARMS
NDA009854 CORTROPHIN-ZINC Approved, discontinued July 29, 1955 ANI PHARMS
NDA010831 CORTICOTROPIN Approved, discontinued September 12, 1957 ORGANICS LAGRANGE
NDA022432 H.P. ACTHAR GEL Approved, marketed October 15, 2010 QUESTCOR PHARMA
ANDA088772 CORTICOTROPIN Approved, discontinued — WATSON LABS

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 2,569
  • Human (MeSH) 1,508
  • Animal only 506
  • Clinical trials 150
  • Randomized controlled trials 66
  • Systematic reviews & meta-analyses 25
  • Case reports 242
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
130
Active
8
With posted results
48

Conditions studied

  • Multiple Sclerosis 10
  • Sarcoidosis 7
  • Rheumatoid Arthritis 7
  • Dermatomyositis 4
  • Proteinuria 4
  • Alcohol Dependence 4
  • Brain Edema 4
  • Brain Tumor 4
  • Uveitis 3
  • Polymyositis 3
  • Multiple Sclerosis, Relapsing-Remitting 3
  • Healthy 3
Study Status Phase Start
Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.
NCT07833163 Peking University People's Hospital
Not yet recruiting Phase 2 Sep 2026
Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease
NCT06964269 Toyos Clinic
Recruiting Phase 4 February 11, 2025
Correlation of Psychological Distress and Immune Checkpoint Inhibitors in Gastric Cancer
NCT07003334 Nanfang Hospital, Southern Medical University
Recruiting — January 3, 2025
Overnight Dexamethasone in Primary Aldosteronism Screening
NCT06740838 Medical University of Gdansk
Recruiting — October 22, 2024
The Effect of Sulfasalazine on CRH Levels in Pregnant Women
NCT05703425 Rutgers, The State University of New Jersey
Recruiting Phase 2 March 1, 2023
Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
NCT05012072 Microgen LLC
Recruiting N/A August 1, 2021
Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women
NCT04037605 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Active, not recruiting Early phase 1 February 9, 2020
Hormonal Mechanisms of Sleep Restriction - Axis Study
NCT03142893 Peter y. Liu
Active, not recruiting Phase 1 May 8, 2017
Cardiorespiratory Fitness Training in Patients With Incomplete Spinal Cord Injury
NCT06259227 Sint Maartenskliniek
Terminated N/A January 11, 2024
Use of CXCL9 as a Biomarker of Acthar Efficacy
NCT02523092 University of California, San Francisco Results posted
Terminated Phase 4 November 3, 2022
Show 40 more studies
Study Status Phase Start
Effect of CRH on Duodenal Markers and Gastric Sensorimotor Function
NCT05071781 Universitaire Ziekenhuizen KU Leuven
Completed Phase 4 May 21, 2021
Acthar for Treatment of Post-transplant FSGS
NCT02399462 University of North Carolina, Chapel Hill
Withdrawn Phase 4 Mar 2021
Corticotropin Stimulation in Adrenal Venous Sampling for Patients With Primary Aldosteronism(ADOPA)
NCT04461535 Chongqing Medical University
Completed N/A July 8, 2020
Impact of Acthar on Everyday Life of Participants With Severe Keratitis
NCT04169061 Mallinckrodt Results posted
Completed Phase 4 November 13, 2019
Adrenocorticotropic Hormone (ACTH) for Post-op Inflammation in Proliferative Vitreoretinopathy (PVR)
NCT03727776 Johns Hopkins University
Completed Early phase 1 August 19, 2019
A Study of Acthar Gel Alone or With Tacrolimus to Reduce Proteinuria in Fibrillary Glomerulopathy Patients
NCT05546047 NephroNet, Inc.
Unknown status Phase 4 March 14, 2019
ACTHAR Therapy for Central Nervous System Sarcoidosis
NCT02920710 The Cleveland Clinic
Withdrawn Phase 4 February 1, 2019
Use of Acthar in Patients With FSGS That Will be Undergoing Renal Transplantation
NCT02683889 University of Colorado, Denver Results posted
Completed Phase 3 February 1, 2019
Comparative and Efficacy Study of ACTHar Gel Alone or in Combination With Tacrolimus in Fibrillary Glomerulopathy
NCT04080076 NephroNet, Inc.
Withdrawn Phase 4 January 12, 2019
A Clinical Study to Evaluate the Potential Role of ACTH Gel in Patients With Scleritis
NCT03465111 Metropolitan Eye Research & Surgery Institute
Unknown status Phase 2 January 1, 2019
Repository Corticotropin Injection in Keratoconjunctivitis Sicca
NCT03398018 University of Alabama at Birmingham
Withdrawn Phase 4 November 1, 2018
Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)
NCT03656692 Mallinckrodt Results posted
Terminated Phase 4 October 5, 2018
The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis
NCT03511625 Attune Health Research, Inc.
Unknown status Phase 3 October 2, 2018
Correlation Between Blood Pressure, Heart Rate and Plasma Corticotropin, Cortisol Under Surgical Skin Incision
NCT03892538 JingCang
Completed — October 1, 2018
Clinical Trial to Investigate CT38 in the Treatment of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome
NCT03613129 LUCINDA BATEMAN, MD Results posted
Completed Phase 1, Phase 2 July 23, 2018
Clinical Impact of Acthar in the Psoriatic Arthritis Patient (CLIPS)
NCT03419650 IRIS Research and Development, LLC
Completed Phase 4 July 20, 2018
Clinical Efficacy of H.P. Acthar Gel 80 U/ml to Improve the Signs and Symptoms in Subjects With Dry Eye Disease
NCT03287635 Toyos Clinic Results posted
Completed Phase 4 July 1, 2018
ACTHAR Gel for Drug REsistant Nephrotic Syndrome in Children
NCT03408405 Rhode Island Hospital
Withdrawn Phase 4 Jun 2018
(ACTH) for the Treatment of Sarcoid Uveitis
NCT03473964 John Huang, MD
Unknown status — April 1, 2018
Adrenocorticotropic Hormone in Membranous Nephropathy
NCT03025828 Icahn School of Medicine at Mount Sinai Results posted
Completed Phase 4 March 19, 2018
Acthar Gel in Participants With Pulmonary Sarcoidosis
NCT03320070 Mallinckrodt Results posted
Completed Phase 4 February 21, 2018
ACTH as A Re-emerging theRapy for Uveitis (The ACTHAR Study)
NCT02931175 Quan Dong Nguyen
Completed Phase 2 November 10, 2017
Predictor of Clinical Response to Acthar in Myositis
NCT03414086 University of Pittsburgh
Completed — November 6, 2017
Use of Acthar in Rheumatoid Arthritis (RA) Related Flares
NCT02541955 Veena Ranganath, MD, MS Results posted
Completed Phase 4 July 20, 2017
Study of Acthar® Gel (Acthar) for Amyotrophic Lateral Sclerosis (ALS)
NCT03068754 Mallinckrodt Results posted
Terminated Phase 2, Phase 3 June 22, 2017
Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)
NCT03126760 Mallinckrodt ARD LLC Results posted
Terminated Phase 4 May 22, 2017
Efficacy and Safety of H.P. ACTHAR GEL in Adults With Retinal Vasculitis
NCT03066869 Ocular Immunology and Uveitis Foundation
Unknown status Phase 4 March 22, 2017
Efficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar Gel
NCT03082573 Iraj Sabahi Research Inc.
Unknown status Phase 4 March 3, 2017
Experience With H.P. Acthar Gel Treatment of Patients With Nephrotic Syndrome/Proteinuria Due to Various Etiologies and Its Effect on Podocyte Function
NCT03644771 Greater Boston Medical Associates
Unknown status — January 25, 2017
Registry for Advanced Sarcodiosis
NCT03769987 University of Cincinnati
Unknown status — January 1, 2017
Effects of ACTHAR on Advanced MRI Surrogate Markers of Disease Activity and on Comprehensive Immune Signature During MS Relapses
NCT03021317 University of Chicago Results posted
Terminated Phase 4 December 20, 2016
Acthar Gel for Active Systemic Lupus Erythematosus (SLE)
NCT02953821 Mallinckrodt Results posted
Completed Phase 4 December 16, 2016
Corticotropin Releasing Hormone (CRH) Responsiveness in Children With Functional Dyspepsia
NCT01373372 Children's Mercy Hospital Kansas City
Withdrawn N/A Dec 2016
Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis
NCT02919761 Mallinckrodt Results posted
Completed Phase 4 November 7, 2016
Acthar for Treatment-Resistant or Treatment-Intolerant Proteinuria
NCT02633046 Mallinckrodt ARD LLC Results posted
Completed Phase 4 October 10, 2016
Acthar SLE (Systemic Lupus Erythematosus)
NCT02779153 NYU Langone Health
Withdrawn Phase 4 Oct 2016
Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar
NCT02546492 University of Maryland, Baltimore Results posted
Terminated Phase 4 Aug 2016
Ocular Sarcoidosis Open Label Trial of ACTHAR Gel
NCT02725177 The Cleveland Clinic Results posted
Completed N/A Jul 2016
Study of H.P. ACTHAR Subcutaneous Gelatin (Gel)(Highly Purified Gel Injection) in Uveitis Patients
NCT02764697 Tampa Bay Uveitis Center, LLC Results posted
Completed Phase 4 June 30, 2016
CRF - Nociceptin Receptor Interactions
NCT03302416 University of Pittsburgh Results posted
Completed Early phase 1 June 1, 2016

All 130 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
20,483
Serious
9,457
With death outcome
696

Most reported reactions

  • Fatigue 1,696
  • Injection site bruising 1,435
  • Insomnia 1,251
  • Drug ineffective 1,204
  • Weight increased 1,123
  • Headache 1,109
  • Injection site pain 1,090
  • Product dose omission issue 1,087
  • Pain 1,009
  • Blood glucose increased 854
  • Peripheral swelling 843
  • Condition aggravated 802

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.