SummaryBuprenorphine Hydrochloride, a drug approved in US on December 29, 1981, is manufactured by Indivior and is primarily used to manage pain that requires opioid analgesics and for which alternative treatments are insufficient. Buprenorphine works as a partial agonist at the mu-opioid receptor and as an antagonist at the kappa-opioid receptor. Its slow rate of dissociation from its receptor, which has been observed in vitro studies, accounts for its longer duration of action compared to morphine, its unpredictability of reversal by opioid antagonists, and its low level of manifest physical dependence. Buprenex is an important drug for pain management and has been widely used in the medical field. |
Drug Type Small molecule drug |
Synonyms BUP-XR, Buprenorphine hydrochloride (JP17/USP), Buprenorphine Transdermal Patch + [38] |
Action antagonists, agonists |
Mechanism κ opioid receptor antagonists(Kappa opioid receptor antagonists), μ opioid receptor agonists(Mu opioid receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date United States (29 Dec 1981), |
RegulationOrphan Drug (United States) |
Molecular FormulaC29H42ClNO4 |
InChIKeyUAIXRPCCYXNJMQ-RZIPZOSSSA-N |
CAS Registry53152-21-9 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D00836 | Buprenorphine Hydrochloride |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Opioid abuse | Canada | 18 Apr 2018 | |
| Chronic Pain | Canada | 21 Jun 2017 | |
| Opium Dependence | Belgium | 02 Nov 1999 | |
| Opium Dependence | Cyprus | 02 Nov 1999 | |
| Opium Dependence | Czechia | 02 Nov 1999 | |
| Opium Dependence | France | 02 Nov 1999 | |
| Opium Dependence | Latvia | 02 Nov 1999 | |
| Opium Dependence | Lithuania | 02 Nov 1999 | |
| Opium Dependence | Luxembourg | 02 Nov 1999 | |
| Opium Dependence | Portugal | 02 Nov 1999 | |
| Substance-Related Disorders | China | 01 Jan 1994 | |
| Anesthesia | Japan | 27 May 1983 | |
| Cancer Pain | Japan | 27 May 1983 | |
| Pain, Postoperative | Japan | 27 May 1983 | |
| Pain | United States | 29 Dec 1981 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Neuralgia | Phase 3 | United States | 01 Mar 2011 | |
| Intervertebral Disc Disease | Phase 3 | China | 01 Aug 2009 | |
| Heroin Dependence | Phase 3 | United States | 01 May 2009 | |
| opioid dependence methadone | Phase 3 | United States | 01 Oct 2006 | |
| Low Back Pain | Phase 3 | Japan | 01 May 2006 | |
| Osteoarthritis, Spine | Phase 3 | United States | 01 Jan 2004 | |
| Opioid-Related Disorders | Phase 3 | United States | 01 Jun 2003 | |
| Diabetes Mellitus, Type 2 | Phase 3 | United States | 01 Apr 2003 | |
| Osteoarthritis | Phase 3 | United States | 01 Apr 2003 | |
| Pain Disorder | Phase 3 | United States | 01 Mar 2001 |
Phase 4 | 23 | BUP microdose induction+Linkage to outpatient BUP treatment (BUP Microdose Induction) | bwkbxrauft = mmzkhzrish owdkxdpxun (zmokhasgdf, ejmsmwjaxg - jrjucfkask) View more | - | 31 Oct 2025 | ||
TAU (Treatment As Usual (TAU)) | bwkbxrauft = dbvcchdpxi owdkxdpxun (zmokhasgdf, oftiueocfb - eyaxkiodem) View more | ||||||
Pubmed Manual | Not Applicable | - | qumujnzmww(bkmryxiuue) = bzzgdhssib yvfaudwivy (txkwdbsrqv ) View more | Positive | 06 Jun 2025 | ||
BUP-TM | qumujnzmww(bkmryxiuue) = ntyovgcrum yvfaudwivy (txkwdbsrqv ) View more | ||||||
PRNewswire | Pubmed Manual | Not Applicable | 322 | vkzkfhdwda(dwdysohudi) = jxlzenoboh zwvswabjij (oioqnpeqxg ) | Positive | 01 May 2025 | ||
Phase 2 | 18 | (Injectable Buprenorphine (BUP-inj)) | iuryiwywut = poeptkejij dpjvcfjmon (ozerdrtbfs, eegrztygks - qqsnnndqps) View more | - | 21 Mar 2025 | ||
Placebo injection (Injectable Placebo (PBO-inj)) | iuryiwywut = xxiptfwaua dpjvcfjmon (ozerdrtbfs, lpkvcbgtyc - twqvwngdci) View more | ||||||
Phase 2 | 97 | Buprenorphine+Onsite treatment (O-BMT (Onsite Treatment)) | tbompscsug = zurvcwwrjq cayfyxpnsn (lzajzmptap, skgzgftgmv - nkrvfpzxzc) View more | - | 14 Jan 2025 | ||
Buprenorphine+Enhanced referral (Enhanced Referral) | tbompscsug = yvwrrbeffw cayfyxpnsn (lzajzmptap, atumarqovc - ooijtsmenp) View more | ||||||
Phase 2 | 643 | Buprenorphine+Pain Coping Skills Training (PCST) (Pain Coping Skills Training) | hquzxvxnlm(ilbknebjut) = ezdsqdzxfc jjgwaodero (nqjxocetyy, 2.02) View more | - | 13 Jan 2025 | ||
(Usual Care) | hquzxvxnlm(ilbknebjut) = hfgguuxlpe jjgwaodero (nqjxocetyy, 2.13) View more | ||||||
Phase 4 | 132 | (Extended-release Buprenorphine: Abdomen) | kbgodbbwzv(xbjpvicihk) = mibatexwce dbajuujvov (gbkvgpuhmo, 41.8) View more | - | 07 Jan 2025 | ||
(Extended-release Buprenorphine: Upper Arm) | kbgodbbwzv(xbjpvicihk) = sgwwxgtiih dbajuujvov (gbkvgpuhmo, 57.4) View more | ||||||
Phase 4 | 12 | (Buprenorphine Dose Reduction) | friutfwpuv(kvywfqkziw) = idaexpiaqx epxxmdgxqe (krodmiohid, 1.5) View more | - | 13 Dec 2024 | ||
(Buprenorphine Full Dose Continuation) | friutfwpuv(kvywfqkziw) = gokvuhsbuk epxxmdgxqe (krodmiohid, 2.4) View more | ||||||
Phase 2 | 38 | Buprenorphine+Cognitive Processing Therapy (CPT) (Buprenorphine + CPT-C) | thakcfrisq(vvuxbxbltu) = pdaqrszbty ysspgqdgjv (privbvtjar, 2.62) View more | - | 19 Aug 2024 | ||
Individual Drug Counseling (IDC)+Buprenorphine (Buprenorphine + IDC) | thakcfrisq(vvuxbxbltu) = kgrolkxafw ysspgqdgjv (privbvtjar, 2.76) View more | ||||||
Phase 4 | 57 | (Buprenorphine 0.15mg + 1% Lidocaine Paracervical Block) | buyroefvrv(bibyegadzv) = rlszesqays mffjitvmdc (otifknefse, ctirmktcxo - txzghjvbny) View more | - | 01 Aug 2023 | ||
(1% Lidocaine Paracervical Block) | buyroefvrv(bibyegadzv) = wvpnlypwya mffjitvmdc (otifknefse, selqkglcic - dfuafgsxsc) View more |





