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Thymopoietin Pentapeptide (THYMOPENTIN)
Thymopoietin Pentapeptide (generic name: THYMOPENTIN) is a thymopentin drug. It is currently in Phase 3 development.
Thymopentin works by mimicking the action of a natural hormone that helps regulate the immune system.
Thymopoietin Pentapeptide, also known as Thymopentin, is a small molecule with a modality of a small molecule. It has been studied in clinical trials for conditions such as HIV Infections, Safety Issues, and Tolerance.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | THYMOPENTIN |
|---|---|
| Drug class | thymopentin |
| Modality | Recombinant protein |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Think of your immune system like a security team that protects your body from harm. Thymopentin helps the immune system work more efficiently by sending signals to the cells that help fight off infections and diseases. This can help boost the body's defenses and prevent illnesses.
Approved indications
Common side effects
Key clinical trials
- Phase1 First in Human Ascending Dose Study to Evaluate the Safety and Tolerability of FC-12738 in Health Adults (PHASE1)
- The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0) (PHASE2)
- Study of Thymopentin in Patients After Curative Resection of Small Hepatocellular Carcinoma (PHASE3)
- Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection (NA)
- Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT / ddI or AZT / ddC) Anti-Retroviral Therapy (PHASE3)
- A Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients (NA)
- Double Blind Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients (NA)
- The Effects of Thymopentin on HIV Infectivity of Blood Cells and Semen in HIV-Infected Patients (NA)
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:
- Thymopoietin Pentapeptide CI brief — competitive landscape report
- Thymopoietin Pentapeptide updates RSS · CI watch RSS
Frequently asked questions about Thymopoietin Pentapeptide
What is Thymopoietin Pentapeptide?
How does Thymopoietin Pentapeptide work?
What is the generic name of Thymopoietin Pentapeptide?
What drug class is Thymopoietin Pentapeptide in?
What development phase is Thymopoietin Pentapeptide in?
Related
- Drug class: All thymopentin drugs
- Therapeutic area: All drugs in Immunology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing