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Naftidan (NAFIVERINE)

Phase 2 active Small molecule

Naftidan (generic name: NAFIVERINE) is a nafiverine drug. It is currently in Phase 2 development.

Nafiverine is thought to work by interacting with a specific molecular target to produce a therapeutic effect.

Nafiverine is a small molecule drug in the nafiverine class, developed by an unknown original developer and currently owned by an unknown entity. Its target and exact mechanism of action are not specified. Nafiverine is not FDA-approved for any indications, and its commercial status, half-life, bioavailability, generic manufacturers, and off-patent status are unknown. As a result, there is limited information available on its safety profile and clinical use. Further research is needed to determine its potential therapeutic applications and risks.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • 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).
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameNAFIVERINE
Drug classnafiverine
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Imagine your body's cells have locks on them, and nafiverine is a key that fits into one of those locks. When it binds to the lock, it triggers a series of events that ultimately lead to a desired outcome, such as relieving a particular symptom or condition. This is a simplified explanation of how nafiverine is believed to work at a molecular level.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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 Naftidan

What is Naftidan?

Naftidan (NAFIVERINE) is a nafiverine drug.

How does Naftidan work?

Nafiverine is thought to work by interacting with a specific molecular target to produce a therapeutic effect.

What is the generic name of Naftidan?

NAFIVERINE is the generic (nonproprietary) name of Naftidan.

What drug class is Naftidan in?

Naftidan belongs to the nafiverine class. See all nafiverine drugs at /class/nafiverine.

What development phase is Naftidan in?

Naftidan is in Phase 2.

Related

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