Summary
Alanine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Hepatitis B would be drug repurposing rather than first-in-human development. This does not mean it is approved for Hepatitis B. ClinicalTrials.gov lists 8 registered trials linking Alanine to Hepatitis B: 1 is active or not yet recruiting; 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00570440). The largest enrolment is 3700000 participants (NCT06184347). Registration activity spans 2007 to 2024. The literature layer holds 9 publications for this pair: 3 systematic reviews, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2001 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Hepatitis B ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Chronic HBV: spontaneous HBsAg loss (functional cure) in 0.5-2%/year on antiviral therapy, 0.1-0.5%/year without treatment; HBeAg seroconversion spontaneous in 5-10%/year; progression to cirrhosis in 20-25% of untreated chronic HBV over 20 years.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 64.0 (trials 22.0, literature 22.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 1 active / not yet recruiting, 5 completed, 2 other |
| Linked publications | 9 (5 clinical trial publications, 3 systematic reviews, 1 randomised controlled trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | ABAT |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00570440 | Continuous Use of COCs 2007 | completed | Phase 4 | 362 |
| NCT01833611 | Entecavir for Chronic Hepatitis B Patients With Persistently Normal ALT 2008 | status unknown | Phase 4 | 130 |
| NCT04723602 | Evaluation of Safety, Tolerability and Immune Responses of Ebola-S and Marburg Vaccines in Healthy Adults 2021 | completed | Phase 1 | 32 |
| NCT05797714 | The Effectiveness and Safety of TMF in the Treatment of Chronic Hepatitis B Patients With Normal ALT. 2022 | active, not recruiting | Not applicable | 200 |
| NCT01226433 | Family Planning Through Dairy Cooperatives 2010 | completed | Not applicable | 319 |
| NCT01463254 | A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan 2011 | completed | Not applicable | 724 |
| NCT01452503 | Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6 2007 | completed | Not applicable | 170 |
| NCT06184347 | Population-wide Research for HBV-related Liver Diseases in Maoming City 2024 | status unknown | Not applicable | 3,700,000 |
Published literature
- Clinical trial publication Phase 3 Results of Bepirovirsen Treatment for Chronic Hepatitis B Virus InfectionHou J, Lim SG, Buti M et al. · The New England journal of medicine · 2026 · PMID 42206582
- Clinical trial publication VIR-2218 (elebsiran) plus pegylated interferon-alfa-2a in participants with chronic hepatitis B virus infection: a phase 2 studyYuen MF, Lim YS, Yoon KT et al. · The lancet. Gastroenterology & hepatology · 2024 · PMID 39389081
- Clinical trial publication Preventing viral relapse with prophylactic tenofovir in hepatitis B carriers receiving chemotherapy: a phase IV randomized study in TaiwanHsu CW, Chen SC, Wang PN et al. · Hepatology international · 2024 · PMID 38376651
- Clinical trial publication Efficacy and safety of the siRNA JNJ-73763989 and the capsid assembly modulator JNJ-56136379 (bersacapavir) with nucleos(t)ide analogues for the treatment of chronic hepatitis B virus infection (REEF-1): a multicentre, double-blind, active-controlled, randomised, phase 2b trialYuen MF, Asselah T, Jacobson IM et al. · The lancet. Gastroenterology & hepatology · 2023 · PMID 37442152
- Clinical trial publication B-Clear Phase 2b Study Design: Establishing the Efficacy and Safety of Bepirovirsen in Patients with Chronic Hepatitis B Virus InfectionCremer J, Elston R, Campbell FM et al. · Advances in therapy · 2023 · PMID 37393402
- Randomized controlled trial Safety, antiviral activity and pharmacokinetics of JNJ-64530440, a novel capsid assembly modulator, as 4 week monotherapy in treatment-naive patients with chronic hepatitis B virus infectionGane EJ, Schwabe C, Berliba E et al. · The Journal of antimicrobial chemotherapy · 2022 · PMID 35040959
- Systematic review Interferon alpha for chronic hepatitis DAbbas Z, Khan MA, Salih M et al. · The Cochrane database of systematic reviews · 2011 · PMID 22161394
- Systematic review Hepatitis B virus infection and related factors in hemodialysis patients in China - systematic review and meta-analysisWang C, Sun J, Zhu B et al. · Renal failure · 2010 · PMID 20954991
- Systematic review Chinese medicinal herbs for chronic hepatitis BLiu JP, McIntosh H, Lin H · The Cochrane database of systematic reviews · 2001 · PMID 11279742
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ABAT. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Alanine approved for Hepatitis B?
Alanine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Hepatitis B would be drug repurposing rather than first-in-human development. This does not mean it is approved for Hepatitis B. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Alanine in clinical trials for Hepatitis B?
ClinicalTrials.gov lists 8 registered trials linking Alanine to Hepatitis B: 1 is active or not yet recruiting; 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00570440). The largest enrolment is 3700000 participants (NCT06184347). Registration activity spans 2007 to 2024.
What does the evidence show for Alanine in Hepatitis B?
Alanine has both completed registered trials and synthesis-level publications linked to Hepatitis B. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ABAT. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.