Tetracosactide

Overview

Tetracosactide (also known as Cosyntropin) is a synthetic peptide that is identical to the 24-amino acid segment (sequence: SYSMEHFRWGKPVGKKRRPVKVYP) at the N-terminal of adrenocorticotropic hormone. ACTH (1-24), a segment similar in all species, contains the biological activity that stimulates production of corticosteroids in the adrenal cortex. Tetracosactide exhibits the same activity as natural ACTH with regard to all its biological activities. The complex results in a product whose absorption in man is effected over a longer period of time as compared to corticotropin. Therefore, therapy may be maintained with less frequent administration.

Indication

For use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency.

Associated Conditions

Acute Gouty Arthritis
Acute Rheumatic Fever
Adrenal Insufficiency
Ankylosing Spondylitis (AS)
Bell's Palsy
Choroiditis
Conjunctivitis
Dermatomyositis (DM)
Iritis
Keratitis
Lupus Erythematosus
Multiple sclerosis exacerbation
Nephrotic Syndrome
Ophthalmia, Sympathetic
Optic Neuritis
Panhypopituitarism
Pemphigus
Periarteritis nodosa
Psoriatic Arthritis
Rheumatoid Arthritis
Scleroderma
Still's Disease
Ulcerative Colitis
Uveitis
Acquired hemolytic jaundice
Exfoliative erythroderma

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis	2020/11/24	NCT04642391	N/A	Completed	University of Virginia
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4)	2020/09/11	NCT04546126	Early Phase 1	Recruiting	Benjamin Viglianti
Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women	2019/07/30	NCT04037605	Early Phase 1	Active, not recruiting	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Comparison of Intramuscular and Intravenous ACTH Stimulation Test in Normal Volunteers	2018/11/23	NCT03752190	Phase 4	Withdrawn	Johns Hopkins University
NeSST2: The Development of a Noninvasive Short Synacthen Test	2018/05/02	NCT03514589	Phase 2	Recruiting	Sheffield Children's NHS Foundation Trust
Is Adrenal Insufficiency Under-diagnosed in Hospitalized Cirrhosis Patients?	2017/12/11	NCT03368066	Phase 3	Completed	University of Virginia
A Novel Approach to Infantile Spasms	2017/11/20	NCT03347526	Phase 3	Suspended	University of Colorado, Denver
Hormonal Mechanisms of Sleep Restriction - Axis Study	2017/05/08	NCT03142893	Phase 1	Active, not recruiting	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)	2016/06/27	NCT02813655	Phase 2	Terminated	Hospices Civils de Lyon
Cosyntropin Versus Epidural Blood Patch (EBP) for Treatment of Treatment of Post Dural Puncture Headache	2015/03/20	NCT02394457	Phase 4	Completed	United States Naval Medical Center, San Diego

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
COSYNTROPIN	HF Acquisition Co LLC, DBA HealthFirst	51662-1567	INTRAVENOUS	0.25 mg in 1 mL	2/22/2024
Cortrosyn	General Injectables & Vaccines, Inc	52584-050	PARENTERAL, INTRAVENOUS, INTRAMUSCULAR	0.25 mg in 1 mL	7/11/2017
Cortrosyn	Henry Schein, Inc.	0404-9839	PARENTERAL, INTRAVENOUS, INTRAMUSCULAR	0.25 mg in 1 mL	1/9/2022
Cosyntropin	Medical Purchasing Solutions, LLC	71872-7313	INTRAVENOUS	0.25 mg in 1 mL	11/3/2023
Cosyntropin	Sandoz Inc	0781-3440	INTRAVENOUS	0.25 mg in 1 mL	7/17/2012

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Synacthen Depot 1mg/1mL injection ampoule	11060	Atnahs Pharma Australia Pty Ltd	Medicine	A	8/2/1991
Synacthen 0.25mg/1mL injection ampoule	11058	Atnahs Pharma Australia Pty Ltd	Medicine	A	8/2/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CORTROSYN INJ 0.25MG	Amphastar Pharmaceuticals	00022381	Powder For Solution - Intravenous , Intramuscular	0.25 MG / VIAL	12/31/1974

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
NUVACTHEN DEPOT 1MG/ML SUSPENSIÓN INYECTABLE	Alfasigma S.P.A.	46454	SUSPENSIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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