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Naropeine

University Hospital, Rouen · Phase 3 active Small molecule Under review

Naropeine is a Small molecule drug developed by University Hospital, Rouen. It is currently in Phase 3 development for Anesthesia for cesarean section, Local anesthesia, Major Nerve Block for Surgery.

Naropeine is being studied in clinical trials for various conditions, including post-mastectomy neuropathic pain syndrome, diaphragmatic paralysis, breast cancer, hysterotomy, and ENT cancers. The interventions being tested include a capsaicin 8% patch, serratus plane block, and botulinum toxin A.

Likelihood of approval
58.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • 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).
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameNaropeine
SponsorUniversity Hospital, Rouen
TargetPotassium channel subfamily K member 3, Sodium channel protein type 1 subunit alpha, Sodium channel protein type 10 subunit alpha
ModalitySmall molecule
Therapeutic areaPain
PhasePhase 3

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Naropeine

What is Naropeine?

Naropeine is a Small molecule drug developed by University Hospital, Rouen, indicated for Anesthesia for cesarean section, Local anesthesia, Major Nerve Block for Surgery.

What is Naropeine used for?

Naropeine is indicated for Anesthesia for cesarean section, Local anesthesia, Major Nerve Block for Surgery, Regional Anesthesia for Labor Pain, Regional Anesthesia for Postoperative Pain.

Who makes Naropeine?

Naropeine is developed by University Hospital, Rouen (see full University Hospital, Rouen pipeline at /company/university-hospital-rouen).

What development phase is Naropeine in?

Naropeine is in Phase 3.

What does Naropeine target?

Naropeine targets Potassium channel subfamily K member 3, Sodium channel protein type 1 subunit alpha, Sodium channel protein type 10 subunit alpha.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing