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ASC40 tablets
ASC40 tablets is a HBV capsid assembly inhibitor Small molecule drug developed by Ascletis Pharmaceuticals Co., Ltd.. It is currently in Phase 3 development for Chronic hepatitis B infection. Also known as: TVB-2640.
ASC40 is a hepatitis B virus (HBV) capsid assembly modulator that disrupts viral particle formation.
ASC40 tablets are a small molecule intervention used to study the safety and potential efficacy in treating conditions such as acne and recurrent glioblastoma. ASC40 tablets are being evaluated in a Phase III extension clinical trial for their long-term safety in patients with moderate to severe acne vulgaris.
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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).
| 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 | ASC40 tablets |
|---|---|
| Also known as | TVB-2640 |
| Sponsor | Ascletis Pharmaceuticals Co., Ltd. |
| Drug class | HBV capsid assembly inhibitor |
| Target | HBV core antigen (capsid assembly) |
| Modality | Small molecule |
| Therapeutic area | Virology / Hepatology |
| Phase | Phase 3 |
Mechanism of action
ASC40 targets the HBV core antigen and inhibits capsid assembly, preventing the formation of infectious viral particles. This mechanism differs from nucleos(t)ide reverse transcriptase inhibitors and represents a novel approach to HBV treatment by directly interfering with virion maturation rather than viral replication.
Approved indications
- Chronic hepatitis B infection
Common side effects
- Elevated transaminases
- Headache
- Fatigue
Key clinical trials
- A Study to Evaluate Safety of ASC40 Tablets in Patients With Moderate to Severe Acne Vulgaris (PHASE3)
- A Study to Evaluate the Safety and Efficacy of ASC40 (Denifanstat) Tablets in the Treatment of Patients With Moderate to Severe Acne Vulgaris (PHASE3)
- Study to Evaluate the Safety and Efficacy of ASC40 in Subjects With Moderate to Severe Acne Vulgaris (PHASE2)
- Study to Evaluate the Safety and Efficacy of ASC40 Tablets in Combination With Bevacizumab in Subjects With rGBM (PHASE3)
- Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects (PHASE1)
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:
- ASC40 tablets CI brief — competitive landscape report
- ASC40 tablets updates RSS · CI watch RSS
- Ascletis Pharmaceuticals Co., Ltd. portfolio CI
Frequently asked questions about ASC40 tablets
What is ASC40 tablets?
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What does ASC40 tablets target?
Related
- Drug class: All HBV capsid assembly inhibitor drugs
- Target: All drugs targeting HBV core antigen (capsid assembly)
- Manufacturer: Ascletis Pharmaceuticals Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Virology / Hepatology
- Indication: Drugs for Chronic hepatitis B infection
- Also known as: TVB-2640
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing