Product Description
Buprenorphine, a partial mu-opoid receptor agonist, has unique pharmacologic properties that distinguish it from methadone and other medications used in the treatment of opioid dependence. It has been shown to be as effective as methadone and is generally safe and well-tolerated. (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2994593/)
Mechanisms of Action: OPRM Agonist,OPRD Antagonist,OPRK Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Sublingual,Transdermal,Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Indivior
Company Location: SLOUGH X0 SL13UH
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, United States
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Neonatal Abstinence Syndrome|Opioid-Related Disorders|Pregnancy Outcomes|Substance Withdrawal Syndrome
Phase 2: Low Back Pain|Radiculopathy|Sciatica
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| NIDA-CTN-0100 | P2 |
Active, not recruiting |
Opioid-Related Disorders |
2026-12-28 |
12% |
2025-06-04 |
Primary Endpoints|Treatments|Trial Status |
| 2UG1DA015831-19 | P2 |
Completed |
Opioid-Related Disorders |
2024-12-06 |
56% |
2025-01-11 |
|
| FIXATUB | P2 |
Not yet recruiting |
Low Back Pain|Sciatica|Radiculopathy |
2020-09-30 |
|||
| ACTRN12625000385448 | P2 |
Not yet recruiting |
Opioid-Related Disorders |
None |
2025-06-02 |
||
| ED-ENVISION | P3 |
Recruiting |
Opioid-Related Disorders |
2027-04-01 |
52% |
2025-01-04 |
Primary Endpoints|Start Date |
| RXR | P3 |
Recruiting |
Opioid-Related Disorders |
2025-10-31 |
14% |
2025-06-12 |
|
| EXHITENTRE | P3 |
Active, not recruiting |
Opioid-Related Disorders |
2025-04-01 |
20% |
2025-02-20 |
|
| MOMs | P3 |
Completed |
Substance Withdrawal Syndrome|Neonatal Abstinence Syndrome|Opioid-Related Disorders|Pregnancy Outcomes |
2025-01-31 |
13% |
2025-06-28 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| MOMs-INO | P3 |
Completed |
Neonatal Abstinence Syndrome|Opioid-Related Disorders|Substance Withdrawal Syndrome|Pregnancy Outcomes |
2024-12-30 |
11% |
2025-02-21 |
Primary Completion Date|Primary Endpoints |
| MOMs-CMA | P3 |
Completed |
Pregnancy Outcomes|Substance Withdrawal Syndrome|Opioid-Related Disorders|Neonatal Abstinence Syndrome |
2024-11-06 |
26% |
2025-02-21 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |