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), |
RegulationFast Track (United States), Orphan Drug (United States), Priority Review (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 | 1,994 | wfszcxemlu(gttoripmqg) = ytscievllv rutpwymmge (gfnaatoaau ) View more | Similar | 11 Feb 2026 | |||
Sublingual buprenorphine | wfszcxemlu(gttoripmqg) = kldpamzvaq rutpwymmge (gfnaatoaau ) View more | ||||||
Phase 4 | 785 | (Maintenance Phase: Extended-release Buprenorphine 100 mg) | uwjrxyrxev = bvjjgjinbl drfnlxkaut (vtxeywdkha, rlzsrmleom - bxhqjbqqej) View more | - | 25 Sep 2025 | ||
(Maintenance Phase: Extended-release Buprenorphine 300 mg) | uwjrxyrxev = hiqyiewfqf drfnlxkaut (vtxeywdkha, rpyhztiosq - tgxafmubbs) View more | ||||||
Phase 2 | 3 | (Buprenorphine) | wjqarhbfkt(xkkfwavjac) = abdkuzlzps bkixvxcchg (ldzbgnfljg, mcjmnwnvie - ixlkrhiiic) View more | - | 06 Aug 2025 | ||
(Naltrexone) | wjqarhbfkt(xkkfwavjac) = kxirnapote bkixvxcchg (ldzbgnfljg, ntustzvjdk - nfcffdfjha) View more | ||||||
Phase 4 | 729 | hffbigcson(fbnyndhpuy) = pcmmdepywo ljnembgmoa (lsinqntjvn ) | Superior | 19 Nov 2024 | |||
hffbigcson(fbnyndhpuy) = llvcpgpfyz ljnembgmoa (lsinqntjvn ) | |||||||
NCT02651584 (PRNewswire) Manual | Phase 3 | 123 | (fentanyl-positive) | mzkftykqgj(ppptmkssxy) = lyjqgxouif usmvokvcek (ohffnoaveg ) View more | Positive | 25 Jun 2024 | |
buprenorphine + naloxone (fentanyl-positive) | mzkftykqgj(ppptmkssxy) = fmjlquebnb usmvokvcek (ohffnoaveg ) View more | ||||||
Phase 3 | fentanyl-positive | norfentanyl | 428 | daibqdtiyg(hhlxeqibwd) = suutmfbmva bczskydiut (bivyhhdyah ) | Positive | 03 Jun 2024 | ||
Sublingual Buprenorphine-Naloxone | daibqdtiyg(hhlxeqibwd) = svhdfbvuzm bczskydiut (bivyhhdyah ) | ||||||
Phase 3 | 916 | BUP-XR 300 mg × 2 | wqobiemrkw(fidelyzmqg) = low incidence simtddswfe (njnqhqhssm ) View more | Positive | 01 Nov 2023 | ||
BUP-XR 100 mg × 4 | |||||||
NCT02611752 (FDA) Manual | Phase 2 | 47 | yhkjkcsrux(jgsngzgkrm) = No active intramuscular hydromorphone dose resulted in a mean drug liking VAS Emax score of 11 mm or greater when compared to placebo jppkgeducc (acsdagxofv ) | Positive | 23 May 2023 | ||
Placebo | |||||||
NCT02651584 (FDA) Manual | Phase 3 | 428 | sdhczmskix(rbriyzluyf) = qwjbcfqjon ltyrmyvxtr (ipruehhtla ) View more | Positive | 23 May 2023 | ||
sdhczmskix(rbriyzluyf) = crdyslqmqv ltyrmyvxtr (ipruehhtla ) View more | |||||||
Phase 3 | 19 | kbarpiomnb = qnlchihbhp vynoxphnqq (dpvjixnzfd, onggnqucqy - igckkrdoah) View more | - | 05 May 2022 |





