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ASC40
ASC40 is a hepatitis B virus (HBV) capsid assembly modulator that disrupts viral particle formation.
ASC40 is a hepatitis B virus (HBV) capsid assembly modulator that disrupts viral particle formation. Used for Chronic hepatitis B infection.
At a glance
| Generic name | ASC40 |
|---|---|
| Sponsor | Ascletis Pharmaceuticals Co., Ltd. |
| Drug class | HBV capsid assembly inhibitor |
| Target | HBV core antigen (HBcAg) |
| 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. By blocking this critical step in the HBV replication cycle, the drug reduces viral load and may promote immune clearance of infected hepatocytes. This mechanism represents a novel approach distinct from nucleos(t)ide reverse transcriptase inhibitors and integrase inhibitors.
Approved indications
- Chronic hepatitis B infection
Common side effects
- Elevated transaminases
- Headache
- Fatigue
Key clinical trials
- TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer (PHASE2)
- 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 CI brief — competitive landscape report
- ASC40 updates RSS · CI watch RSS
- Ascletis Pharmaceuticals Co., Ltd. portfolio CI