Last reviewed · How we verify
Triptolide Wilfordii
Triptolide Wilfordii is a Immunosuppressant Small molecule drug developed by Peking Union Medical College Hospital. It is currently in Phase 3 development for Rheumatoid arthritis.
Triptolide Wilfordii is a diterpenoid epoxide derived from the Chinese herb Tripterygium wilfordii, which has anti-inflammatory and immunosuppressive properties.
Triptolide is a small molecule with the synonyms NSC-163062 and TRIPTOLIDE, extracted from Tripterygium Wilfordii Hook F. It has been studied in clinical trials for conditions such as HIV, AIDS/HIV PROBLEM, HIV-infection/AIDS, and Polycystic Kidney disease.
-
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 | Triptolide Wilfordii |
|---|---|
| Sponsor | Peking Union Medical College Hospital |
| Drug class | Immunosuppressant |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
It works by inhibiting the production of pro-inflammatory cytokines and suppressing the activity of immune cells, leading to a reduction in inflammation and immune response. This mechanism of action is thought to contribute to its therapeutic effects in treating various diseases.
Approved indications
- Rheumatoid arthritis
Common side effects
- Nausea
- Vomiting
- Diarrhea
Key clinical trials
- Safety and Efficacy of Triptolide Wilfordii in New Onset HIV-1 Infection (PHASE3)
- Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease (NA)
- Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir In Acute HIV-1 Infection (PHASE3)
- Safety and Efficacy Study of TwHF in HIV Patients With Poor Immune Responses (NA)
- Impact on T Cell Immune Activation and Inflammation of Triptolide Woldifii in HIV-infected Immunological Non-responders (PHASE1, PHASE2)
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:
- Triptolide Wilfordii CI brief — competitive landscape report
- Triptolide Wilfordii updates RSS · CI watch RSS
- Peking Union Medical College Hospital portfolio CI
Frequently asked questions about Triptolide Wilfordii
What is Triptolide Wilfordii?
How does Triptolide Wilfordii work?
What is Triptolide Wilfordii used for?
Who makes Triptolide Wilfordii?
What drug class is Triptolide Wilfordii in?
What development phase is Triptolide Wilfordii in?
What are the side effects of Triptolide Wilfordii?
Related
- Drug class: All Immunosuppressant drugs
- Manufacturer: Peking Union Medical College Hospital — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing