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Low Dose Fentanyl
Low Dose Fentanyl is a Small molecule drug developed by Tel-Aviv Sourasky Medical Center. It is currently in Phase 1 development.
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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 | Low Dose Fentanyl |
|---|---|
| Sponsor | Tel-Aviv Sourasky Medical Center |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Nausea
- Vomiting
- Dizziness
- Severe pain
- Shingles
- Procedure site swelling
- Respiratory Depression
- Tachycardia
- Diaphoresis
- Dural Puncture
Key clinical trials
- EEG and Pain Monitor Data Under Anesthesia to Study Pharmacodynamic Effects of Opioids and Sedatives (NA)
- Extended-release Buprenorphine as a Novel Low-dose Induction Strategy (PHASE2)
- Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation (PHASE4)
- Epidural vs. Dural Puncture Epidural in Labor Analgesia (NA)
- Effect of Dexmedetomidine Dosage on Postoperative Delirium in Geriatric Orthopedic Surgery (PHASE2)
- A Study to Investigate of the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle (PHASE4)
- Comparison of Prolotherapy and Rehabilitation Treatments in Low Back Pain (CPRTLBP) (NA)
- Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy. (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:
- Low Dose Fentanyl CI brief — competitive landscape report
- Low Dose Fentanyl updates RSS · CI watch RSS
- Tel-Aviv Sourasky Medical Center portfolio CI
Frequently asked questions about Low Dose Fentanyl
What is Low Dose Fentanyl?
Who makes Low Dose Fentanyl?
What development phase is Low Dose Fentanyl in?
What are the side effects of Low Dose Fentanyl?
Related
- Manufacturer: Tel-Aviv Sourasky Medical Center — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing