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Tetracosactin
Tetracosactin is a Small molecule drug developed by Istanbul University. It is currently in Phase 1 development. Also known as: Synacthen.
Tetracosactin, also known as tetracosactide, is a synthetic analogue of adrenocorticotropic hormone (ACTH) used in clinical trials to study various conditions such as stress, adrenal insufficiency, cirrhosis, spur cell anemia, and lecithin acyltransferase deficiency.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Tetracosactin |
|---|---|
| Also known as | Synacthen |
| Sponsor | Istanbul University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Updated Diagnostic Cortisol Values for Adrenal Insufficiency (NA)
- Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Groups 2, 3 & 4) (EARLY_PHASE1)
- Stress and the Nervous System (NA)
- Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women (EARLY_PHASE1)
- Hormonal Mechanisms of Sleep Restriction - Axis Study (PHASE1)
- Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE) (PHASE2)
- Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease (EARLY_PHASE1)
- Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tetracosactin CI brief — competitive landscape report
- Tetracosactin updates RSS · CI watch RSS
- Istanbul University portfolio CI
Frequently asked questions about Tetracosactin
What is Tetracosactin?
Who makes Tetracosactin?
Is Tetracosactin also known as anything else?
What development phase is Tetracosactin in?
Related
- Manufacturer: Istanbul University — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Synacthen
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing