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Nimodipine group

University Hospital Hradec Kralove · Phase 3 active Small molecule Under review Quality 0/100

Nimodipine group is a Dihydropyridine calcium channel blocker Small molecule drug developed by University Hospital Hradec Kralove. It is currently in Phase 3 development for Subarachnoid hemorrhage with cerebral vasospasm, Ischemic stroke prevention and treatment. Also known as: nimodipine, Nimotop.

Nimodipine is a dihydropyridine calcium channel blocker that selectively inhibits L-type calcium channels in vascular smooth muscle, causing vasodilation and improved cerebral blood flow.

Nimodipine is a small molecule that acts as a mineralocorticoid receptor antagonist. It has been studied in various clinical trials for conditions such as subarachnoid hemorrhage, knee osteoarthritis, and stroke.

Likelihood of approval
55.3% 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).
  • 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 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 nameNimodipine group
Also known asnimodipine, Nimotop
SponsorUniversity Hospital Hradec Kralove
Drug classDihydropyridine calcium channel blocker
TargetL-type voltage-gated calcium channel
ModalitySmall molecule
Therapeutic areaNeurology / Cardiovascular
PhasePhase 3

Mechanism of action

Nimodipine preferentially acts on cerebral blood vessels compared to peripheral vessels, reducing vasospasm and improving microcirculation in the brain. By blocking calcium influx into vascular smooth muscle cells, it prevents vasoconstriction and enhances oxygen delivery to ischemic brain tissue. This mechanism is particularly beneficial in conditions involving cerebral vasospasm and reduced cerebral perfusion.

Approved indications

Common side effects

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 Nimodipine group

What is Nimodipine group?

Nimodipine group is a Dihydropyridine calcium channel blocker drug developed by University Hospital Hradec Kralove, indicated for Subarachnoid hemorrhage with cerebral vasospasm, Ischemic stroke prevention and treatment.

How does Nimodipine group work?

Nimodipine is a dihydropyridine calcium channel blocker that selectively inhibits L-type calcium channels in vascular smooth muscle, causing vasodilation and improved cerebral blood flow.

What is Nimodipine group used for?

Nimodipine group is indicated for Subarachnoid hemorrhage with cerebral vasospasm, Ischemic stroke prevention and treatment.

Who makes Nimodipine group?

Nimodipine group is developed by University Hospital Hradec Kralove (see full University Hospital Hradec Kralove pipeline at /company/university-hospital-hradec-kralove).

Is Nimodipine group also known as anything else?

Nimodipine group is also known as nimodipine, Nimotop.

What drug class is Nimodipine group in?

Nimodipine group belongs to the Dihydropyridine calcium channel blocker class. See all Dihydropyridine calcium channel blocker drugs at /class/dihydropyridine-calcium-channel-blocker.

What development phase is Nimodipine group in?

Nimodipine group is in Phase 3.

What are the side effects of Nimodipine group?

Common side effects of Nimodipine group include Headache, Hypotension, Flushing, Dizziness, Gastrointestinal disturbances.

What does Nimodipine group target?

Nimodipine group targets L-type voltage-gated calcium channel and is a Dihydropyridine calcium channel blocker.

Related

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