Cosyntropin (tetracosactide)

Also known as: Synacthen · tetracosactrin · Cortrosyn

FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval FDA-approved 4 applications
Randomized controlled trials 128 of 1,992 publications on PubMed
Registered clinical trials 56 11 active
Adverse event reports 453 407 classified as serious
  • Cosyntropin (tetracosactide) is an FDA-approved drug, marketed as Cortrosyn, Cosyntropin (first approval: April 22, 1970).
  • PubMed lists 1,992 publications mentioning it, including 128 randomized controlled trials and 212 animal-only studies.
  • ClinicalTrials.gov lists 56 registered studies testing it (11 active).
  • FDA's adverse event system (FAERS) holds 453 reports mentioning it; 407 classified as serious. Reports do not prove causation.

Research topics

  • Hydrocortisone 85
  • Adrenal Insufficiency 62
  • Adrenocorticotropic Hormone 35
  • Hyperaldosteronism 24
  • Aldosterone 23
  • Adrenal Glands 21
  • Glucocorticoids 20
  • Pituitary-Adrenal System 19
  • Hypothalamo-Hypophyseal System 18
  • Adrenalectomy 14

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

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
NDA016750 CORTROSYN Approved, marketed April 22, 1970 AMPHASTAR PHARMS INC
NDA022028 COSYNTROPIN Approved, discontinued February 21, 2008 SANDOZ
ANDA090574 COSYNTROPIN Approved, discontinued December 17, 2009 PHARMOBEDIENT
ANDA202147 COSYNTROPIN Approved, marketed June 29, 2012 SANDOZ

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 1,992
  • Human (MeSH) 1,538
  • Animal only 212
  • Clinical trials 219
  • Randomized controlled trials 128
  • Systematic reviews & meta-analyses 18
  • Case reports 295
  • 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
56
Active
11
With posted results
8

Conditions studied

  • Adrenal Insufficiency 19
  • Polycystic Ovary Syndrome 6
  • Hyperandrogenemia 4
  • Obesity 4
  • Polymyalgia Rheumatica 2
  • Giant Cell Arteritis 2
  • Sleep Restriction 2
  • Hypopituitarism 2
  • Type 1 Diabetes 2
  • Cirrhosis 2
  • Primary Aldosteronism 2
  • Stress 2
Study Status Phase Start
Prevalence of Adrenal Insufficiency and Associated Factors in Rheumatoid Arthritis Patients Using Low-dose Corticosteroids.
NCT07866326 Bursa Yuksek Ihtisas Training and Research Hospital
Recruiting — July 31, 2026
Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease
NCT06190158 Brigham and Women's Hospital
Active, not recruiting Early phase 1 May 15, 2024
Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency
NCT05435781 Marianne Christina Klose
Recruiting Phase 4 June 7, 2022
Updated Diagnostic Cortisol Values for Adrenal Insufficiency
NCT05149638 Montefiore Medical Center
Recruiting N/A February 3, 2022
Hydrocortisone and Placebo in Patients With Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment
NCT05193396 Marianne Andersen
Recruiting Phase 4 February 1, 2022
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)
NCT04546126 Benjamin Viglianti
Recruiting Early phase 1 November 1, 2021
Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
NCT04519580 Kresten Krarup Keller
Active, not recruiting — September 14, 2020
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
Screening and Stimulation Testing for Residual Secretion of Adrenal Steroid Hormones in Autoimmune Addison's Disease
NCT03793114 University of Bergen
Active, not recruiting N/A September 26, 2018
Hormonal Mechanisms of Sleep Restriction - Axis Study
NCT03142893 Peter y. Liu
Active, not recruiting Phase 1 May 8, 2017
Show 40 more studies
Study Status Phase Start
NeSST2: The Development of a Noninvasive Short Synacthen Test
NCT03514589 Sheffield Children's NHS Foundation Trust
Recruiting Phase 2 October 12, 2012
Post-corticosteroid Insufficiency: Search for a Threshold Value for Cortisol at 8 Hours, Prospective Study
NCT06208098 Assistance Publique - Hôpitaux de Paris
Unknown status N/A March 1, 2024
Diagnosis of Adrenal Insufficiency in Liver Cirrhosis Patients
NCT06206655 Seoul National University Hospital
Unknown status — December 1, 2023
Improving Survivorship and Health-related Quality of Life in Patients With Primary Brain Tumours
NCT06014398 Royal College of Surgeons, Ireland
Unknown status N/A September 1, 2023
Study to Explore the Effect of Dapagliflozin and Stress in Adolescent and Adult Subjects With Type 1 Diabetes (T1D)
NCT04234867 Kinderkrankenhaus auf der Bult
Terminated Phase 1 May 18, 2022
Impact of Exogenous Estrogens on Cotisol Levels During Synacthen Stimulation
NCT05302726 Copenhagen University Hospital, Rigshospitalet
Unknown status N/A January 1, 2022
Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis
NCT04642391 University of Virginia
Completed — August 2, 2021
Corticotropin Stimulation in Adrenal Venous Sampling for Patients With Primary Aldosteronism(ADOPA)
NCT04461535 Chongqing Medical University
Completed N/A July 8, 2020
Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS
NCT03905603 University of Virginia
Unknown status Early phase 1 October 8, 2019
Comparison of Intramuscular and Intravenous ACTH Stimulation Test in Normal Volunteers
NCT03752190 Johns Hopkins University
Withdrawn Phase 4 Jul 2019
A Study to Assess the Efficacy and Safety of MNK-1411 in Duchenne Muscular Dystrophy
NCT03400852 Mallinckrodt ARD LLC Results posted
Terminated Phase 2 July 27, 2018
Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
NCT01422096 University of Virginia
Withdrawn Early phase 1 June 1, 2018
Effect of Longer-term Adrenal Suppression Using Low Dose Hydrocortisone on Androgen Overproduction
NCT01422733 University of Virginia
Withdrawn Early phase 1 June 1, 2018
A Novel Approach to Infantile Spasms
NCT03347526 University of Colorado, Denver
Suspended Phase 3 April 19, 2018
Is Adrenal Insufficiency Under-diagnosed in Hospitalized Cirrhosis Patients?
NCT03368066 University of Virginia Results posted
Completed Phase 3 January 29, 2018
Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
NCT01422707 University of Virginia
Withdrawn Early phase 1 January 19, 2018
Effect of Adrenocorticotropic Hormone on Vascular Endothelial Growth Factor Release in Children Study
NCT03709381 Nationwide Children's Hospital
Completed Early phase 1 October 1, 2017
Cortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon
NCT03074123 Bnai Zion Medical Center
Completed N/A April 1, 2017
Prevalence of Adrenal Insufficiency in Kidney Transplanted Patients in Glucocorticoid Treatment
NCT03136562 Copenhagen University Hospital, Rigshospitalet
Completed — March 20, 2017
Salivary Free Cortisol Response to Cosyntropin Stimulation Test in Mitotane Treated Patients
NCT03083834 Bnai Zion Medical Center
Unknown status N/A March 14, 2017
Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)
NCT02813655 Hospices Civils de Lyon
Terminated Phase 2 Oct 2016
Mass Spectrometry Based Cutoffs for Cortisol After Stimulation Tests
NCT02818660 Haukeland University Hospital
Completed N/A May 21, 2016
The Influence of Psychobiological Adversity to Children and Adolescents With Type 1 Diabetes
NCT02575001 University of Ljubljana, Faculty of Medicine
Completed — Jul 2015
Stress and the Nervous System
NCT02339506 Brigham and Women's Hospital Results posted
Completed N/A Apr 2015
Diagnosis of Central Adrenal Insufficiency in Patients With Prader-Willi Syndrome
NCT02368379 Nationwide Children's Hospital
Completed N/A Mar 2014
Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS)
NCT01764711 Vanderbilt University Results posted
Completed N/A Jan 2013
Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures
NCT01673087 University of Michigan
Completed Phase 1 Oct 2012
Value of 25 mcg Cortrosyn Stimulation Test
NCT01428336 The Cleveland Clinic Results posted
Completed N/A Sep 2011
Difference in GC-induced Adrenal Insufficiency in RA Related to Polymorphisms in the Glucocorticoid Receptor Gene
NCT01411046 Copenhagen University Hospital, Rigshospitalet
Unknown status — Apr 2011
Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism
NCT02127840 Charles University, Czech Republic
Unknown status Phase 4 Mar 2011
Revival of Stem Cells in Addison's Study
NCT01371526 Newcastle University
Completed Phase 4 Sep 2010
Cosyntropin Versus Epidural Blood Patch (EBP) for Treatment of Treatment of Post Dural Puncture Headache
NCT02394457 United States Naval Medical Center, San Diego Results posted
Completed Phase 4 Aug 2010
The Adrenal Contribution to Androgen Production in Girls During Puberty
NCT01062568 University of California, San Diego Results posted
Completed Phase 3 Feb 2010
Optimization of the Evaluation of the Adrenal Function After Discontinuation of a Prolonged Therapy With Corticosteroids
NCT01053754 Assistance Publique Hopitaux De Marseille
Terminated N/A Jan 2010
Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome
NCT00989781 University of California, San Diego Results posted
Completed N/A Sep 2009
Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment
NCT00975078 University Hospital, Basel, Switzerland
Completed Phase 4 May 2009
Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery
NCT01839812 Mayo Clinic
Completed Phase 1 Mar 2009
Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen Test
NCT00851942 Cardiff University
Completed Phase 4 Sep 2008
Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy
NCT00694863 Radboud University Medical Center
Completed Phase 2 Jul 2008
Stress, Hypothalamic-pituitary-adrenal (HPA) Dysfunction, and Relapse in Alcoholism
NCT00744588 University of Texas Southwestern Medical Center
Completed — Aug 2007

All 56 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
453
Serious
407
With death outcome
55

Most reported reactions

  • Pneumonia 28
  • Foetal growth restriction 26
  • Foetal exposure during pregnancy 25
  • Hypoglycaemia 25
  • Hypotension 23
  • Dyspnoea 22
  • Nausea 18
  • Adrenal insufficiency 16
  • Asthenia 16
  • Drug ineffective 16
  • Off label use 16
  • Rash 16

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.

  • Cortrosyn HUMAN PRESCRIPTION DRUG Amphastar Pharmaceuticals, Inc. January 30, 2025
  • Cortrosyn HUMAN PRESCRIPTION DRUG Medical Purchasing Solutions, LLC April 12, 2024
  • COSYNTROPIN HUMAN PRESCRIPTION DRUG HF Acquisition Co LLC, DBA HealthFirst February 22, 2024
  • Cosyntropin HUMAN PRESCRIPTION DRUG Sandoz Inc January 10, 2024
  • Cosyntropin HUMAN PRESCRIPTION DRUG Medical Purchasing Solutions, LLC November 3, 2023

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.