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Psigodal (MEPIPRAZOLE)

Phase 2 active Small molecule

Psigodal (generic name: MEPIPRAZOLE) is a drug. It is currently in Phase 2 development.

Mepiprazole is thought to work by modulating neurotransmitter activity in the brain.

Mepiprazole, also known as Psigodal, is a small molecule drug with unknown target and drug class. It is currently owned by an unspecified company, and its commercial status is unclear. Mepiprazole is used to treat unspecified indications, but its FDA approval status is unknown. The drug's pharmacokinetic properties, including half-life and bioavailability, are also unknown. Further research is needed to fully understand the safety and efficacy of mepiprazole.

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 nameMEPIPRAZOLE
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Imagine your brain is a busy city with many different streets and intersections. Mepiprazole helps to regulate the flow of traffic by adjusting the signals that control the movement of neurotransmitters, which are like the cars on the road. This can help to improve communication between different parts of the brain and alleviate symptoms of certain conditions.

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 Psigodal

What is Psigodal?

Psigodal (MEPIPRAZOLE) is a Small molecule drug.

How does Psigodal work?

Mepiprazole is thought to work by modulating neurotransmitter activity in the brain.

What is the generic name of Psigodal?

MEPIPRAZOLE is the generic (nonproprietary) name of Psigodal.

What development phase is Psigodal in?

Psigodal is in Phase 2.

Related

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