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Rutergan (FENETHAZINE)

Phase 2 active Small molecule

Rutergan (generic name: FENETHAZINE) is a fenethazine drug. It is currently in Phase 2 development.

Fenethazine is thought to work by interacting with a specific target in the body, although its exact mechanism of action is not well understood.

Fenethazine is a small molecule drug in the fenethazine class, but its target and exact mechanism of action are unknown. It is not clear if it is FDA-approved or commercially available. Fenethazine is not a well-documented drug, and its pharmacokinetic properties, such as half-life and bioavailability, are also unknown. As a result, there is limited information available on its approved indications, generic manufacturers, or patent status. Further research is needed to understand the clinical utility and safety profile of fenethazine.

Likelihood of approval
12.3% 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).
  • CNS / neurology attrition -3.0pp
    CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
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 nameFENETHAZINE
Drug classfenethazine
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Imagine your body's cells have locks on them, and fenethazine is a key that fits into one of those locks. When it binds to the lock, it can either turn the lock open or closed, depending on the type of lock and the key's shape. This can affect how cells behave and communicate with each other, but the exact details of how fenethazine works are still a mystery.

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 Rutergan

What is Rutergan?

Rutergan (FENETHAZINE) is a fenethazine drug.

How does Rutergan work?

Fenethazine is thought to work by interacting with a specific target in the body, although its exact mechanism of action is not well understood.

What is the generic name of Rutergan?

FENETHAZINE is the generic (nonproprietary) name of Rutergan.

What drug class is Rutergan in?

Rutergan belongs to the fenethazine class. See all fenethazine drugs at /class/fenethazine.

What development phase is Rutergan in?

Rutergan is in Phase 2.

Related

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