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Ajmalin (AJMALINE)

Phase 3 active Small molecule Quality 36/100

Ajmalin (generic name: AJMALINE) is a ajmaline drug. It is currently in Phase 3 development for Cardiac arrhythmia, Supraventricular arrhythmia, Ventricular arrhythmia.

Ajmaline works by blocking potassium channels in the heart to help regulate heart rhythm.

Ajmaline, a small molecule drug, targets the potassium voltage-gated channel subfamily A member 5 to treat cardiac arrhythmias, including supraventricular and ventricular arrhythmias. Its mechanism of action involves blocking potassium channels, which helps to regulate heart rhythm. The commercial status of ajmaline is unclear, and it may be patented or have generic manufacturers. Key safety considerations include its potential to cause cardiac side effects. Ajmaline has a half-life of 7.3 hours.

Likelihood of approval
56.3% 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).
  • Cardiovascular Phase 3 risk -2.0pp
    Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
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 nameAJMALINE
Drug classajmaline
TargetPotassium voltage-gated channel subfamily A member 5
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 3

Mechanism of action

Think of your heart as a pump that beats in a regular rhythm. Potassium channels help control how fast the heart beats. Ajmaline blocks these channels, which helps to slow down the heart rate and restore a normal rhythm.

Approved indications

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 Ajmalin

What is Ajmalin?

Ajmalin (AJMALINE) is a ajmaline drug, indicated for Cardiac arrhythmia, Supraventricular arrhythmia, Ventricular arrhythmia.

How does Ajmalin work?

Ajmaline works by blocking potassium channels in the heart to help regulate heart rhythm.

What is Ajmalin used for?

Ajmalin is indicated for Cardiac arrhythmia, Supraventricular arrhythmia, Ventricular arrhythmia.

What is the generic name of Ajmalin?

AJMALINE is the generic (nonproprietary) name of Ajmalin.

What drug class is Ajmalin in?

Ajmalin belongs to the ajmaline class. See all ajmaline drugs at /class/ajmaline.

What development phase is Ajmalin in?

Ajmalin is in Phase 3.

What does Ajmalin target?

Ajmalin targets Potassium voltage-gated channel subfamily A member 5 and is a ajmaline.

Related

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