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Parinase (GLYPINAMIDE)

Phase 2 active Small molecule Quality 19/100

Parinase (generic name: GLYPINAMIDE) is a glypinamide drug. It is currently in Phase 2 development.

Parinase works by modulating ion channels in the nervous system.

Parinase (GLYPINAMIDE) is a small molecule drug in the glypinamide class, but its target and exact mechanism of action are unknown. It is not clear if it is FDA-approved or commercially available. There is limited information available on its pharmacokinetic properties, such as half-life and bioavailability. Parinase is not listed as an off-patent or generic medication. Further research is needed to understand its clinical use and safety profile.

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 nameGLYPINAMIDE
Drug classglypinamide
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Imagine your nerve cells are like electrical wires. Parinase helps control the flow of electrical signals by adjusting the channels that allow these signals to pass through. This can help regulate various bodily functions, but the exact details of how it works are still unclear.

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 Parinase

What is Parinase?

Parinase (GLYPINAMIDE) is a glypinamide drug.

How does Parinase work?

Parinase works by modulating ion channels in the nervous system.

What is the generic name of Parinase?

GLYPINAMIDE is the generic (nonproprietary) name of Parinase.

What drug class is Parinase in?

Parinase belongs to the glypinamide class. See all glypinamide drugs at /class/glypinamide.

What development phase is Parinase in?

Parinase is in Phase 2.

Related

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