Last reviewed 2026-05-27 · How we verify

Niguldipine Fumarate (DEXNIGULDIPINE)

Phase 2 active Small molecule ✓ Verified May 2026

Niguldipine Fumarate (generic name: DEXNIGULDIPINE) is a dexniguldipine drug. It is currently in Phase 2 development.

DEXNIGULDIPINE works by selectively blocking the Alpha-1A adrenergic receptor, which helps to regulate blood vessel constriction and blood pressure.

Niguldipine fumarate is a small molecule with the synonyms DEXNIGULDIPINE, DEXNIGULDIPINO, and (R)-NIGULDIPINE.

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	DEXNIGULDIPINE
Drug class	dexniguldipine
Target	Adenosine receptor A3, Multidrug resistance protein 1, Alpha-1A adrenergic receptor
Modality	Small molecule
Therapeutic area	Hematology
Phase	Phase 2

Mechanism of action

Imagine your blood vessels are like roads in your body. When they constrict, it's like narrowing the roads, which can increase blood pressure. DEXNIGULDIPINE helps to keep these roads open by blocking a specific receptor that causes them to constrict.

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:

Niguldipine Fumarate CI brief — competitive landscape report
Niguldipine Fumarate updates RSS · CI watch RSS

Frequently asked questions about Niguldipine Fumarate

What is Niguldipine Fumarate?

Niguldipine Fumarate (DEXNIGULDIPINE) is a dexniguldipine drug.

How does Niguldipine Fumarate work?

DEXNIGULDIPINE works by selectively blocking the Alpha-1A adrenergic receptor, which helps to regulate blood vessel constriction and blood pressure.

What is the generic name of Niguldipine Fumarate?

DEXNIGULDIPINE is the generic (nonproprietary) name of Niguldipine Fumarate.

What drug class is Niguldipine Fumarate in?

Niguldipine Fumarate belongs to the dexniguldipine class. See all dexniguldipine drugs at /class/dexniguldipine.

What development phase is Niguldipine Fumarate in?

Niguldipine Fumarate is in Phase 2.

What does Niguldipine Fumarate target?

Niguldipine Fumarate targets Adenosine receptor A3, Multidrug resistance protein 1, Alpha-1A adrenergic receptor and is a dexniguldipine.

Drug class: All dexniguldipine drugs
Target: All drugs targeting Adenosine receptor A3, Multidrug resistance protein 1, Alpha-1A adrenergic receptor
Therapeutic area: All drugs in Hematology

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