Last reviewed · How we verify
TMC435 HPMC capsule
TMC435 HPMC capsule is a HCV NS3/4A protease inhibitor Small molecule drug developed by Tibotec Pharmaceuticals, Ireland. It is currently in Phase 1 development.
TMC435 inhibits the HCV NS3/4A serine protease, blocking viral polyprotein processing and preventing hepatitis C virus replication.
TMC435 HPMC capsule is a small molecule used to treat Hepatitis C. It is administered in the form of a capsule, with HPMC (hydroxypropyl methylcellulose) as a component.
-
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 | TMC435 HPMC capsule |
|---|---|
| Sponsor | Tibotec Pharmaceuticals, Ireland |
| Drug class | HCV NS3/4A protease inhibitor |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
TMC435 is a direct-acting antiviral that selectively binds to and inhibits the NS3/4A serine protease of hepatitis C virus. This protease is essential for cleaving the HCV polyprotein into functional viral proteins. By blocking this enzyme, TMC435 prevents viral replication and reduces viral load in infected patients.
Approved indications
Common side effects
Key clinical trials
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:
- TMC435 HPMC capsule CI brief — competitive landscape report
- TMC435 HPMC capsule updates RSS · CI watch RSS
- Tibotec Pharmaceuticals, Ireland portfolio CI
Frequently asked questions about TMC435 HPMC capsule
What is TMC435 HPMC capsule?
How does TMC435 HPMC capsule work?
Who makes TMC435 HPMC capsule?
What drug class is TMC435 HPMC capsule in?
What development phase is TMC435 HPMC capsule in?
Related
- Drug class: All HCV NS3/4A protease inhibitor drugs
- Manufacturer: Tibotec Pharmaceuticals, Ireland — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing