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Subutex
Subutex is a Small molecule drug developed by Indivior Inc.. It is currently in Phase 2 development. Also known as: buprenorphine.
Subutex, also known as buprenorphine, is used to treat opioid use disorder, opioid dependence, and opioid-related disorders. It can be administered through various methods, including sublingual, buccal, injection, transdermal, and implant.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Subutex |
|---|---|
| Also known as | buprenorphine |
| Sponsor | Indivior Inc. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Examining Analgesic Synergy and Efficacy in Trauma Care (PHASE4)
- Chicago Data-driven Opioid Use Disorder Screening, Engagement, Treatment and Planning System (NA)
- Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections (PHASE2)
- Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
- Open Trial of Technology-Enhanced Behavioral Intervention for Buprenorphine Retention in Pregnant and Postpartum People (EARLY_PHASE1)
- Extended-release Buprenorphine as a Novel Low-dose Induction Strategy (PHASE2)
- Pain Management Teams Using Whole Health to Optimize Function and Safety in Veterans: The TEAMWORK Trial (NA)
- Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Subutex CI brief — competitive landscape report
- Subutex updates RSS · CI watch RSS
- Indivior Inc. portfolio CI
Frequently asked questions about Subutex
What is Subutex?
Who makes Subutex?
Is Subutex also known as anything else?
What development phase is Subutex in?
Related
- Manufacturer: Indivior Inc. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: buprenorphine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing