Last reviewed · How we verify

Digenin (KAINIC ACID)

Phase 2 active Small molecule

Digenin (generic name: KAINIC ACID) is a drug. It is currently in Phase 2 development.

Kainic Acid activates the Glutamate receptor ionotropic, kainate 4, leading to excitotoxicity and neuronal damage.

Digenin, also known as Kainic Acid, is a small molecule modality targeting the Glutamate receptor ionotropic, kainate 4. Its mechanism of action involves activating this receptor subtype, leading to excitotoxicity and neuronal damage. However, its exact clinical use and commercial status are unclear. As a result, there is limited information available on its approved indications, half-life, bioavailability, and generic manufacturers. Further research is needed to fully understand its pharmacological properties and potential therapeutic applications.

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 nameKAINIC ACID
TargetAdenosine receptor A3, Glutamate receptor 1, Glutamate receptor 2
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Imagine your brain cells have special locks on them. Kainic Acid is a key that fits into one of these locks, causing the cell to become overactive and eventually die. This can be useful in research settings, but it's not a treatment for any specific medical condition.

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 Digenin

What is Digenin?

Digenin (KAINIC ACID) is a Small molecule drug.

How does Digenin work?

Kainic Acid activates the Glutamate receptor ionotropic, kainate 4, leading to excitotoxicity and neuronal damage.

What is the generic name of Digenin?

KAINIC ACID is the generic (nonproprietary) name of Digenin.

What development phase is Digenin in?

Digenin is in Phase 2.

What does Digenin target?

Digenin targets Adenosine receptor A3, Glutamate receptor 1, Glutamate receptor 2.

Related

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