Last reviewed · How we verify
SL-BUP
SL-BUP is a Small molecule drug developed by NYU Langone Health. It is currently in Phase 2 development. Also known as: sublingual buprenorphine, Suboxone.
SL-BUP is a small molecule used in medication treatment for opioid-related disorders, including drug addiction and substance abuse. It is administered through various forms, including injection and sublingual products.
-
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 | SL-BUP |
|---|---|
| Also known as | sublingual buprenorphine, Suboxone |
| Sponsor | NYU Langone Health |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
- Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study
- A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder (PHASE4)
- Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR) (PHASE3)
- Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) (PHASE2)
- EXHIT ENTRE Comparative Effectiveness Trial (PHASE2, PHASE3)
- OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder (NA)
- Medication Treatment for Opioid Use Disorder in Expectant Mothers (PHASE3)
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:
- SL-BUP CI brief — competitive landscape report
- SL-BUP updates RSS · CI watch RSS
- NYU Langone Health portfolio CI
Frequently asked questions about SL-BUP
What is SL-BUP?
Who makes SL-BUP?
Is SL-BUP also known as anything else?
What development phase is SL-BUP in?
Related
- Manufacturer: NYU Langone Health — full pipeline
- Also known as: sublingual buprenorphine, Suboxone
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing