Clevudine
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Also known as ClevudinaL-FMAULevovirClevudineÊClevudineÂClevudine (Levovir)
Summary
Clevudine (CHEMBL458875) is a phase-3 clinical-stage small molecule (ATC J05AF12); indicated across 4 conditions including chronic hepatitis b virus infection and hepatitis b virus infection.
At a glance
- Status: Max clinical phase 3 (not approved)
- Modality: Small molecule
- ATC class: J05AF12
- Indications: 4 conditions
- Clinical trials: 26
- Chemistry: 260.22 Da · C10H13FN2O5
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL458875 |
| Name | Clevudine |
| Type | Small molecule |
| Max phase | 3 |
| FDA approved | no |
| PubChem CID | 73115 |
| ATC | J05AF12 |
| Molecular formula | C10H13FN2O5 |
| Molecular weight | 260.22 |
| InChIKey | GBBJCSTXCAQSSJ-XQXXSGGOSA-N |
SMILES: CC1=CN(C(=O)NC1=O)[C@@H]2[C@@H]([C@H]([C@@H](O2)CO)O)F
IUPAC name: 1-[(2S,3R,4S,5S)-3-fluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-methylpyrimidine-2,4-dione
Also known as: Clevudina, Clevudine, L-FMAU, Levovir, CLEVUDINE, ClevudineÊ, ClevudineÂ, Clevudine (Levovir), clevudine
Patent coverage: 956 distinct patent families (3,383 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
4 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| chronic hepatitis B virus infection | 3 | MONDO:0005366 | EFO:0004239 |
| hepatitis B virus infection | 3 | MONDO:0005344 | EFO:0004197 |
| viral infectious disease | 3 | MONDO:0005108 | EFO:0000763 |
| severe acute respiratory syndrome | 2 | MONDO:0005091 | MONDO:0100096 |
Clinical trials
Total trials: 26.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE4 | 11 |
| PHASE3 | 9 |
| PHASE2 | 6 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT00501124 | PHASE4 | COMPLETED | Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) Chronic HBV |
| NCT00558493 | PHASE4 | COMPLETED | Switching Study From Lamivudine to Clevudine in the Chronic Hepatitis B Patients |
| NCT00558818 | PHASE4 | COMPLETED | Long-term Study With Clevudine |
| NCT00641082 | PHASE4 | COMPLETED | A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function |
| NCT00798460 | PHASE4 | TERMINATED | Efficacy of Clevudine Plus Lamivudine for Lamivudine-resistant Chronic Hepatitis B Patients |
| NCT01263002 | PHASE4 | COMPLETED | A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With HBV Associated-HCC |
| NCT01264094 | PHASE4 | TERMINATED | A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period |
| NCT01264133 | PHASE4 | TERMINATED | A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B |
| NCT01264354 | PHASE4 | COMPLETED | An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B |
| NCT01264367 | PHASE4 | COMPLETED | A Study to Evaluate the Efficacy and Safety of Clevudine and Peg-interferon in Sequence Compared With Clevudine Alone in the Patients With HBeAg(+) Chronic Hepatitis B or Clevudine and Peg-interferon Sequential Treatment in Patients With Chronic Hepatitis B Who Have HBeAg(+) |
| NCT01266005 | PHASE4 | TERMINATED | A Study to Compare and Evaluate Intrahepatic cccDNA Reduction After Administrating Clevudine or Entecavir in the Chronic HBV Patients |
| NCT00313274 | PHASE3 | TERMINATED | Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patients With HBeAg(-) Chronic HBV |
| NCT00313287 | PHASE3 | TERMINATED | Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patient With Chronic HBV |
| NCT00362505 | PHASE3 | TERMINATED | Safety and Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials |
| NCT00362635 | PHASE3 | COMPLETED | Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30mg Versus Lamivudine 100mg for CHB Infection |
| NCT00496002 | PHASE3 | TERMINATED | Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus |
| NCT00496158 | PHASE3 | TERMINATED | Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus |
| NCT00672867 | PHASE3 | COMPLETED | A Pilot Study to Evaluate the Safety and Efficacy of Clevudine or Adefovir Patients With LC-B |
| NCT00823342 | PHASE3 | TERMINATED | ANRS HB 05 Multicenter Study Evaluating Efficacy and Safety of Clevudine Monotherapy Versus Tenofovir Monotherapy Versus Combination Therapy of Clevudine and Tenofovir for 96 Weeks in HBeAg Negative Patients With Chronic Hepatitis B, naïve to Anti-VHB Therapy |
| NCT01192854 | PHASE3 | COMPLETED | An Study of Efficacy and Safety of Clevudine |
| NCT00044135 | PHASE2 | UNKNOWN | A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus. |
| NCT00305019 | PHASE2 | TERMINATED | Safety and Antiviral Activity of Clevudine in Patients Infected With Hepatitis B Virus |
| NCT00313261 | PHASE2 | TERMINATED | Safety and Efficacy Study of L-FMAU in Chronic HBV Patients of L-FMAU-201 Placebo Group |
| NCT00362700 | PHASE2 | TERMINATED | Safety and Efficacy Study of Retreated Clevudine in Chronic HBV Patients Who Received Clevudine in L-FMAU-201 |
| NCT04347915 | PHASE2 | COMPLETED | The Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Moderate COVID-19 |
| NCT04891302 | PHASE2 | COMPLETED | The Proof of Concept Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Mild and Moderate COVID-19 |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).