Last reviewed · How we verify
Nubain
Nubain is a Small molecule drug developed by Children's Healthcare of Atlanta. It is currently in Phase 3 development.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Nubain |
|---|---|
| Sponsor | Children's Healthcare of Atlanta |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants (PHASE1)
- Study of Nalbuphine ER in Participants With Hepatic Impairment (PHASE1)
- Erector Spinae Plane Block for Pain Control After Open Abdominal Surgery (NA)
- Comparison of Intrathecal Nalbuphine Versus Intrathecal Tramadol as Adjuvants in Subarachnoid Block for Lower Limb Orthopaedic Surgeries (NA)
- Effect of Nalbuphine Versus Fentanyl on Hemdoynamic Effects of Laryngoscopy (PHASE4)
- NAL ER IPF Respiratory Function and Safety Study (PHASE1)
- Comparison Of Clinical Outcomes of Intraperitoneal Bupivacaine Instillation Versus Placebo as Preemptive Analgesia in Patients Undergoing Open Appendectomy (PHASE1)
- Intravenous Nalbuphine Versus Lidocaine for Prevention of Propofol Injection Pain (NA)
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:
- Nubain CI brief — competitive landscape report
- Nubain updates RSS · CI watch RSS
- Children's Healthcare of Atlanta portfolio CI
Frequently asked questions about Nubain
What is Nubain?
Who makes Nubain?
What development phase is Nubain in?
Related
- Manufacturer: Children's Healthcare of Atlanta — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing