Drugs / Clevudine
Clevudine
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01581242 | Apr → Jun 2012 | — | Bukwang Pharmaceutical | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT04891302 | Mar → Jul 2021 | COVID-19 | Bukwang Pharmaceutical | Completed | No outcome recorded |
| Phase 2 | NCT04347915 | May 2020 → Feb 2021 | COVID-19 | Bukwang Pharmaceutical | Completed | No outcome recorded |
| Phase 2 | NCT00362700 | Jul 2003 → Oct 2005 | hepatitis B virus infection | Bukwang Pharmaceutical | Terminated | No outcome recorded |
| Phase 2 | NCT00313261 | Jun 2003 → Feb 2005 | chronic hepatitis B virus infection | Bukwang Pharmaceutical | Terminated | No outcome recorded |
| Phase 2 | NCT00044135 | Aug 2002 → ? | hepatitis B virus infection | Triangle Pharmaceuticals | Unknown | No outcome recorded |
| Phase 2 | NCT00305019 | Jul 2002 → Mar 2004 | hepatitis B virus infection | Bukwang Pharmaceutical | Terminated | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT01192854 | Feb 2010 → May 2011 | chronic hepatitis B virus infection | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00672867 | Dec 2007 → Nov 2012 | — | Bukwang Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT00496002 | Aug 2007 → ? | chronic hepatitis B virus infection | Pharmasset | Terminated | No outcome recorded |
| Phase 3 | NCT00496158 | Aug 2007 → ? | chronic hepatitis B virus infection | Pharmasset | Terminated | No outcome recorded |
| Phase 3 | NCT00362635 | Aug 2006 → Dec 2011 | hepatitis B virus infection | Bukwang Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT00362505 | Jun 2004 → Mar 2006 | hepatitis B virus infection | Bukwang Pharmaceutical | Terminated | No outcome recorded |
| Phase 3 | NCT00313274 | Jul 2003 → Dec 2004 | chronic hepatitis B virus infection | Bukwang Pharmaceutical | Terminated | No outcome recorded |
| Phase 3 | NCT00313287 | Jun 2003 → Nov 2004 | chronic hepatitis B virus infection | Bukwang Pharmaceutical | Terminated | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT01263002 | Jun 2010 → Jan 2013 | hepatocellular carcinoma | Bukwang Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT01264354 | Mar 2010 → Aug 2012 | chronic hepatitis B virus infection | Bukwang Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT01264094 | Nov 2009 → Nov 2014 | chronic hepatitis B virus infection | Bukwang Pharmaceutical | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01264133 | Sep 2009 → Jun 2013 | chronic hepatitis B virus infection | Bukwang Pharmaceutical | Terminated | No outcome recorded |
| Phase 4 | NCT01266005 | Aug 2009 → Aug 2013 | chronic hepatitis B virus infection | Bukwang Pharmaceutical | Terminated | No outcome recorded |
| Phase 4 | NCT01264367 | Dec 2008 → Aug 2013 | chronic hepatitis B virus infection | Bukwang Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT00641082 | Feb 2008 → Mar 2012 | chronic hepatitis B virus infection | Bukwang Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT00558493 | Nov 2007 → ? | chronic hepatitis B virus infection | Bukwang Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT00558818 | Jun 2007 → Sep 2011 | chronic hepatitis B virus infection | Bukwang Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT00501124 | May 2007 → Jul 2010 | chronic hepatitis B virus infection | Bukwang Pharmaceutical | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 3 | NCT00823342 Comparator | Dec 2008 | chronic hepatitis B virus infection | French National Agency for Research on AIDS and Viral Hepatitis | Terminated | No outcome recorded |
| Phase 4 | NCT01595633 Background | Mar 2012 → Feb 2014 | chronic hepatitis B virus infection | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT00798460 Comparator | Dec 2008 → Jun 2010 | chronic hepatitis B virus infection | Inje University | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2009-03-13 | Eisai Inc. | Regulatory Approval of Clevudine for the Treatment of Chronic Hepatitis B in the Philippines eisai.com ↗
HI-Eisai Pharmaceutical Inc. (Headquarters: Makati City, the Philippines, President: Lourdes Magno), a subsidiary in the Philippines of Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito), announced today that the Bureau of Food and Drugs (BFAD) approved “Clevudine” (generic name) for the inhibition of virus replication in chronic hepatitis B patients (HbeAg positive or HbeAg negative) with evidence of active viral replication and elevations in serum aminotransferases (ALT or AST). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2009-03-13 | Eisai Inc. | Approval of Clevudine for the Treatment of Chronic Hepatitis B in the Philippines eisai.com ↗ |
| 2003-06-24 | Gilead Sciences | Gilead and Bukwang End Licensing Agreement for Clevudine, Investigational Agent for Chronic Hepatitis B gilead.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Clevudine | “Nucleoside analogues (Lamivudine 100mg, Telbivudine 600mg, Entecavir 1mg, or Clevudine 30mg)” NCT01595633 ↗ |
| Known as | Clevudina | ChEMBL registry synonym — accepted as the source's own label CHEMBL458875 ↗ |
| Known as | L-FMAU | “A Double-Blind, Randomized, Parallel, Placebo-Controlled Phase III Study to Evaluate the Safety and Antiviral Activity of Clevudine (L-FMAU) 30 mg QD in Patients With HBeAg...” NCT00313274 ↗2“The purpose of this study is to determine safety and efficacy of 30 mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in patients with chronic HBV.” NCT00313287 ↗ “of L-FMAU (Clevudine) in Chronic Hepatitis B Patients” NCT00313261 ↗ |
| Known as | Levovir | ChEMBL registry synonym — accepted as the source's own label CHEMBL458875 ↗ |
| Modality | Small molecule | “Clevudine is a nucleoside analog with an unnatural beta-L configuration.” PMID 16628625 ↗ May 2006 |
| Route | Oral | “After Oral Administration” NCT01581242 ↗ |