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Sufentanil NanoTab
Sufentanil NanoTab is a Small molecule drug developed by Talphera, Inc. It is currently in Phase 2 development. Also known as: ARX-F01.
Sufentanil NanoTab is a small molecule that acts as a mu opioid receptor agonist, classified as an agonist drug. It is used to treat pain, including postoperative pain, and has been studied in clinical trials for its efficacy and safety in patients undergoing elective surgeries such as unilateral knee replacement.
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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 | Sufentanil NanoTab |
|---|---|
| Also known as | ARX-F01 |
| Sponsor | Talphera, Inc |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Sufentanil NanoTab PCA System/15 mcg for Acute Post-Operative Pain in Vertebral Surgery: A Preliminary Investigation
- Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty (NA)
- Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics (PHASE1)
- Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 mcg (Zalviso™) for Post-Operative Pain in Patients After Knee or Hip Replacement Surgery (PHASE3)
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery (PHASE3)
- Effect of Delivery Route on PK of Sufentanil NanoTab (PHASE1)
- Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab (PHASE1)
- A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain (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:
- Sufentanil NanoTab CI brief — competitive landscape report
- Sufentanil NanoTab updates RSS · CI watch RSS
- Talphera, Inc portfolio CI
Frequently asked questions about Sufentanil NanoTab
What is Sufentanil NanoTab?
Who makes Sufentanil NanoTab?
Is Sufentanil NanoTab also known as anything else?
What development phase is Sufentanil NanoTab in?
Related
- Manufacturer: Talphera, Inc — full pipeline
- Also known as: ARX-F01
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing