Summary
Betaine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Hepatitis C would be drug repurposing rather than first-in-human development. This does not mean it is approved for Hepatitis C. ClinicalTrials.gov lists 3 registered trials linking Betaine to Hepatitis C: 1 has completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Early Phase 1 (NCT00882193). The largest enrolment is 30 participants (NCT00310336). Registration activity spans 2006 to 2009. The literature layer holds 1 publication for this pair: 1 clinical trial publication. The dated items are from 2010. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Hepatitis C ranks 357 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: Spontaneous clearance in <30% of acute cases; chronic infection rarely clears without treatment (<1%/year).
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 26.0 (trials 4.0, literature 2.0, tier 15, approved bonus 5.0) |
| Registered trials | 3 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 2 other |
| Linked publications | 1 (1 clinical trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | other/unknown |
| Data sources | DGIdb |
| Linked via biomarker / target | BHMT2 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00882193 | Pilot Study of Betaine + Combination Antiviral Therapy for Chronic Hepatitis C Genotype 1 Non-responder/Relapsers 2009 | terminated | Early Phase 1 | 2 |
| NCT00310336 | Chronic Hepatitis C Non-Responder Study With AdoMet and Betaine 2006 | completed | PHASE2, PHASE3 | 30 |
| NCT00571714 | Pilot Comparison of Standard Antiviral Therapy With and Without 12 Weeks of Betaine in Genotype 1 Naive Patients 2008 | withdrawn | Not applicable | — |
Published literature
- Clinical trial publication S-adenosyl-methionine and betaine improve early virological response in chronic hepatitis C patients with previous nonresponseFilipowicz M, Bernsmeier C, Terracciano L et al. · PloS one · 2010 · PMID 21079746
Mechanism and notes
Recorded mechanism or class: other/unknown.
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 BHMT2. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Betaine approved for Hepatitis C?
Betaine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Hepatitis C would be drug repurposing rather than first-in-human development. This does not mean it is approved for Hepatitis C. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Betaine in clinical trials for Hepatitis C?
ClinicalTrials.gov lists 3 registered trials linking Betaine to Hepatitis C: 1 has completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Early Phase 1 (NCT00882193). The largest enrolment is 30 participants (NCT00310336). Registration activity spans 2006 to 2009.
What does the evidence show for Betaine in Hepatitis C?
Betaine has 1 completed trial and 1 linked publication for Hepatitis C. Completed trials may or may not have posted results; follow the NCT links to check. 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 BHMT2. 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 2026-07-05. Page built 2026-10-07.