Last reviewed 2026-05-31 · How we verify

Prajmaline (PRAJMALIUM)

Phase 2 active Small molecule Under review

Prajmaline (generic name: PRAJMALIUM) is a prajmalium drug. It is currently in Phase 2 development for Ventricular arrhythmia.

Prajmaline works by blocking sodium channels in the heart, which helps to regulate abnormal heart rhythms.

Prajmaline is a small molecule with the synonyms BITARTRATE DE PRAJMALIUM, BITARTRATO DE PRAJMALIO, GT-1012, NEO GILURYTHMAL, NEO-GILURYTMAL, and NPA-P. It has been studied in clinical trials for conditions such as Brugada Syndrome and Sudden Death, specifically in relation to its effects when used as the intervention Ajmaline.

Likelihood of approval

13.3% 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).
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	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 name	PRAJMALIUM
Drug class	prajmalium
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 2

Mechanism of action

Imagine your heart is like a city with many streets. Sodium channels are like traffic lights that control the flow of electrical signals through the heart. When these channels get stuck, it can cause abnormal heart rhythms. Prajmaline helps to fix these traffic lights, allowing the heart to beat normally.

Approved indications

Ventricular arrhythmia

Common side effects

No common side effects on file.

Key clinical trials

The Response To Ajmaline Provocation in Healthy Subjects (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial 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:

Prajmaline CI brief — competitive landscape report
Prajmaline updates RSS · CI watch RSS

Frequently asked questions about Prajmaline

What is Prajmaline?

Prajmaline (PRAJMALIUM) is a prajmalium drug, indicated for Ventricular arrhythmia.

How does Prajmaline work?

Prajmaline works by blocking sodium channels in the heart, which helps to regulate abnormal heart rhythms.

What is Prajmaline used for?

Prajmaline is indicated for Ventricular arrhythmia.

What is the generic name of Prajmaline?

PRAJMALIUM is the generic (nonproprietary) name of Prajmaline.

What drug class is Prajmaline in?

Prajmaline belongs to the prajmalium class. See all prajmalium drugs at /class/prajmalium.

What development phase is Prajmaline in?

Prajmaline is in Phase 2.

Drug class: All prajmalium drugs
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Ventricular arrhythmia

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