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Neovir (CRIDANIMOD)

Phase 3 active Small molecule ✓ Verified Jun 2026

Neovir (generic name: CRIDANIMOD) is a cridanimod drug. It is currently in Phase 3 development.

Neovir works by modulating the immune system to treat a specific condition.

Neovir, also known as Cridanimod, is a small molecule drug in the cridanimod class. Its original development is attributed to an unknown entity, and it is currently owned by an unspecified company. The target and indications for Neovir are not publicly disclosed, and its commercial status, including patent and generic availability, is unknown. The drug's pharmacokinetic properties, such as half-life and bioavailability, are also not available. Further information on Neovir's safety profile and efficacy is required to fully understand its clinical utility.

Likelihood of approval
59.3% 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).
  • Immunology slight uplift +1.0pp
    Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
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 nameCRIDANIMOD
Drug classcridanimod
TargetStimulator of interferon genes protein, Trypsin
ModalitySmall molecule
Therapeutic areaImmunology
PhasePhase 3

Mechanism of action

Imagine your immune system is like a security guard that protects you from harm. Neovir helps the guard work more efficiently by fine-tuning its response to threats, reducing unnecessary inflammation and damage. This can help alleviate symptoms and improve outcomes for patients with certain conditions.

Approved indications

No approved indications tracked.

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 Neovir

What is Neovir?

Neovir (CRIDANIMOD) is a cridanimod drug.

How does Neovir work?

Neovir works by modulating the immune system to treat a specific condition.

What is the generic name of Neovir?

CRIDANIMOD is the generic (nonproprietary) name of Neovir.

What drug class is Neovir in?

Neovir belongs to the cridanimod class. See all cridanimod drugs at /class/cridanimod.

What development phase is Neovir in?

Neovir is in Phase 3.

What does Neovir target?

Neovir targets Stimulator of interferon genes protein, Trypsin and is a cridanimod.

Related

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