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.
Background
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 |
|---|---|---|---|---|---|
2020/11/24 | N/A | Completed | |||
2020/09/11 | Early Phase 1 | Recruiting | Benjamin Viglianti | ||
2019/07/30 | Early Phase 1 | Active, not recruiting | |||
2018/11/23 | Phase 4 | Withdrawn | |||
2018/05/02 | Phase 2 | Recruiting | |||
2017/12/11 | Phase 3 | Completed | |||
2017/11/20 | Phase 3 | Suspended | |||
2017/05/08 | Phase 1 | Active, not recruiting | |||
2016/06/27 | Phase 2 | Terminated | |||
2015/03/20 | Phase 4 | Completed | United States Naval Medical Center, San Diego |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1567 | INTRAVENOUS | 0.25 mg in 1 mL | 2/22/2024 | |
| General Injectables & Vaccines, Inc | 52584-050 | PARENTERAL, INTRAVENOUS, INTRAMUSCULAR | 0.25 mg in 1 mL | 7/11/2017 | |
| Henry Schein, Inc. | 0404-9839 | PARENTERAL, INTRAVENOUS, INTRAMUSCULAR | 0.25 mg in 1 mL | 1/9/2022 | |
| Medical Purchasing Solutions, LLC | 71872-7313 | INTRAVENOUS | 0.25 mg in 1 mL | 11/3/2023 | |
| 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 | Medicine | A | 8/2/1991 | |
| Synacthen 0.25mg/1mL injection ampoule | 11058 | Medicine | A | 8/2/1991 |