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Opiates
Opiates is a Small molecule drug developed by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal. It is currently in Phase 2 development. Also known as: Analgesics, Narcotics, morphine, fentanyl.
Opiates are alkaloid compounds naturally found in the opium poppy plant Papaver somniferum, including morphine, codeine, and thebaine. They work by binding to opioid receptors in the brain, specifically mu, kappa, and delta receptors, as antagonists.
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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 | Opiates |
|---|---|
| Also known as | Analgesics, Narcotics, morphine, fentanyl, buprenorphine |
| Sponsor | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal |
| 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)
- Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine (PHASE3)
- A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade (PHASE2)
- Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections (PHASE2)
- Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1) (PHASE2, PHASE3)
- Dextromethorphan for Treatment of Postoperative Pain (NA)
- Intercostal Nerve Cryoablation Versus Epidural Analgesia for Nuss Repair of Pectus Excavatum (NA)
- Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy (PHASE4)
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:
- Opiates CI brief — competitive landscape report
- Opiates updates RSS · CI watch RSS
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal portfolio CI
Frequently asked questions about Opiates
What is Opiates?
Who makes Opiates?
Is Opiates also known as anything else?
What development phase is Opiates in?
Related
- Manufacturer: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Analgesics, Narcotics, morphine, fentanyl, buprenorphine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing