Last reviewed 2026-04-20 · How we verify

Ledakrin (NITRACRINE)

Phase 2 active Small molecule

Ledakrin (generic name: NITRACRINE) is a nitracrine drug. It is currently in Phase 2 development.

Ledakrin works by binding to a specific target in the body, although the exact nature of this interaction is not well understood.

Ledakrin (NITRACRINE) is a small molecule nitracrine drug with an unknown target. Its mechanism of action is not well-documented, and it has not been approved by the FDA for any indications. As a result, there is limited information available on its commercial status, safety considerations, or pharmacokinetic properties. Further research is needed to fully understand the potential benefits and risks of this compound. Due to the lack of available data, it is difficult to provide a comprehensive summary of Ledakrin.

Likelihood of approval

15.3% 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).

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	NITRACRINE
Drug class	nitracrine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine Ledakrin as a key that fits into a lock in the body. When it binds to its target, it can help to regulate various cellular processes, but the exact way it does this is still a mystery. More research is needed to fully understand how Ledakrin works and what effects it may have on the body.

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:

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

Frequently asked questions about Ledakrin

What is Ledakrin?

Ledakrin (NITRACRINE) is a nitracrine drug.

How does Ledakrin work?

Ledakrin works by binding to a specific target in the body, although the exact nature of this interaction is not well understood.

What is the generic name of Ledakrin?

NITRACRINE is the generic (nonproprietary) name of Ledakrin.

What drug class is Ledakrin in?

Ledakrin belongs to the nitracrine class. See all nitracrine drugs at /class/nitracrine.

What development phase is Ledakrin in?

Ledakrin is in Phase 2.

Drug class: All nitracrine drugs
Therapeutic area: All drugs in Other

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