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i.v. fentanyl
i.v. fentanyl is a Small molecule drug developed by YM BioSciences. It is currently in Phase 1 development. Also known as: fetanyl citrate injection.
Fentanyl administered intravenously is used for patient-controlled analgesia and epidural analgesia to manage pain. It is also studied for its effects on mobility and anesthesia in various clinical trials.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | i.v. fentanyl |
|---|---|
| Also known as | fetanyl citrate injection |
| Sponsor | YM BioSciences |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Comparative Study Between Opioids Free Anesthesia and Opioid Anesthesia in Patients With Supratentorial Tumor Resection (NA)
- Affective Effects of Pre-surgery Opioids: a Randomized, Doubleblind Placebo-controlled Trial (PHASE4)
- Non-opioid Anesthesia Based on Thoracic Paravertebral Block During Laparoscopic Sleeve Gastrectomy (NA)
- Nociception Level During Opioid-sparing Anaesthesia Versus Conventional Opioid-based Anaesthesia (NA)
- The Effect of Methylprednisolone on the Reversal Time of Rocuronium by Sugammadex in the Pediatric Patient Group (PHASE4)
- Regional Anesthesia Techniques in Breast Surgery (NA)
- Multimodal Analgesia Versus Peripheral Nerve Block for Postoperative Pain Management After Lower Limb Injury Surgery (NA)
- Efficacy and Safety of Liposomal Bupivacaine and Ropivacaine in Upper Limb Surgery (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:
- i.v. fentanyl CI brief — competitive landscape report
- i.v. fentanyl updates RSS · CI watch RSS
- YM BioSciences portfolio CI
Frequently asked questions about i.v. fentanyl
What is i.v. fentanyl?
Who makes i.v. fentanyl?
Is i.v. fentanyl also known as anything else?
What development phase is i.v. fentanyl in?
Related
- Manufacturer: YM BioSciences — full pipeline
- Also known as: fetanyl citrate injection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing