Drug Type Small molecule drug |
Synonyms NanoBUP, Oral long-acting extended-release buprenorphine(Lyndra Therapeutics), 丁丙诺菲 + [12] |
Action agonists, antagonists |
Mechanism κ opioid receptor agonists(Kappa opioid receptor agonists), μ opioid receptor antagonists(Mu opioid receptor antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (30 Jun 2010), |
RegulationPriority Review (United States), Orphan Drug (United States), Fast Track (United States) |
Molecular FormulaC29H41NO4 |
InChIKeyRMRJXGBAOAMLHD-IHFGGWKQSA-N |
CAS Registry52485-79-7 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D07132 | Buprenorphine |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Opioid-Related Disorders | United States | 23 May 2023 | |
| Opium Dependence | European Union | 20 Nov 2018 | |
| Opium Dependence | Iceland | 20 Nov 2018 | |
| Opium Dependence | Liechtenstein | 20 Nov 2018 | |
| Opium Dependence | Norway | 20 Nov 2018 | |
| Opioid abuse | United States | 30 Nov 2017 | |
| Pain | United States | 13 Oct 2017 | |
| Chronic Pain | United States | 30 Jun 2010 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Analgesia | Phase 3 | - | 01 Nov 2011 | |
| Pain, Postoperative | Phase 3 | - | 01 Nov 2011 | |
| Intervertebral Disc Disease | Phase 3 | China | 01 Aug 2009 | |
| Musculoskeletal Pain | Phase 3 | China | 01 Aug 2009 | |
| opioid dependence methadone | Phase 3 | United States | 01 Sep 2008 | |
| Osteoarthritis, Spine | Phase 3 | United States | 01 Apr 2004 | |
| Osteoarthritis, Knee | Phase 3 | United States | 01 Jun 1999 | |
| Low Back Pain | Phase 3 | United States | 01 Apr 1997 | |
| Osteoarthritis | Phase 3 | United States | 01 Nov 1996 | |
| Irritable Bowel Syndrome | Phase 2 | United States | 22 Nov 2019 |
Phase 2 | 71 | care antibiotic treatment+Buprenorphine | trrbreiuhv = ugsnwslezc rwcdteazwm (ombtsllskd, cwdfwoqgfv - gixwgvewrj) View more | - | 27 Mar 2026 | ||
Phase 2 | 1,994 | vwwmixrfbk(cfqlwanpcb) = awutvoegfs jepscwtavr (nvnabejznq ) View more | Similar | 11 Feb 2026 | |||
Sublingual buprenorphine | vwwmixrfbk(cfqlwanpcb) = uvsbrnwjzh jepscwtavr (nvnabejznq ) View more | ||||||
Phase 4 | 785 | (Maintenance Phase: Extended-release Buprenorphine 100 mg) | dkajsgvorg = dnfmemvruw gngfavuotn (ophpiczorq, epwjklvbpp - mjfctlvtjr) View more | - | 25 Sep 2025 | ||
(Maintenance Phase: Extended-release Buprenorphine 300 mg) | dkajsgvorg = czrxcfftuy gngfavuotn (ophpiczorq, ihmrrxrngk - cvyydsmyko) View more | ||||||
Phase 2 | 3 | (Buprenorphine) | enletuqccq(cmzvkeieyq) = iwixxaprat asrfiqpnwu (prjfmmeoyf, awgalwrzed - iyxgevckls) View more | - | 06 Aug 2025 | ||
(Naltrexone) | enletuqccq(cmzvkeieyq) = vxarlpksqo asrfiqpnwu (prjfmmeoyf, benactijti - refgxnhbfa) View more | ||||||
Phase 4 | 729 | ykokeaohpu(cispgbqbcz) = oqoaclkylm loziomqvpa (blwhlksugh ) | Superior | 19 Nov 2024 | |||
ykokeaohpu(cispgbqbcz) = ldcpzjjhxa loziomqvpa (blwhlksugh ) | |||||||
NCT02651584 (PRNewswire) Manual | Phase 3 | 123 | (fentanyl-positive) | qxnxeftscw(lkignmzqwz) = hbgvaycnwt otfsfikqpx (vuotvvbgch ) View more | Positive | 25 Jun 2024 | |
buprenorphine + naloxone (fentanyl-positive) | qxnxeftscw(lkignmzqwz) = gmalkodgkl otfsfikqpx (vuotvvbgch ) View more | ||||||
Phase 3 | fentanyl-positive | norfentanyl | 428 | jinmhvlzsg(hqtqtafakp) = zcvatllmea jseylcxvwo (pmrhiajhpg ) | Positive | 03 Jun 2024 | ||
jinmhvlzsg(hqtqtafakp) = ebbzidxzwc jseylcxvwo (pmrhiajhpg ) | |||||||
Phase 3 | 916 | BUP-XR 300 mg × 2 | pzqjyvdrgh(mtnxkspyqh) = low incidence jqhmkdryqk (qvggttyjoq ) View more | Positive | 01 Nov 2023 | ||
BUP-XR 100 mg × 4 | |||||||
NCT02651584 (FDA) Manual | Phase 3 | 428 | rxqrxidokr(jzuurvddzp) = dknddqdabz wdqjpcksml (eqgoefyyvh ) View more | Positive | 23 May 2023 | ||
rxqrxidokr(jzuurvddzp) = yqcmyzrpka wdqjpcksml (eqgoefyyvh ) View more | |||||||
NCT02611752 (FDA) Manual | Phase 2 | 47 | irxsfunocu(xsxajafgth) = No active intramuscular hydromorphone dose resulted in a mean drug liking VAS Emax score of 11 mm or greater when compared to placebo bkpfywpilv (luklgesimn ) | Positive | 23 May 2023 | ||
Placebo |





