Nimotop

(Nimodipine)

ApprovedSmall molecule

Nimodipine is used to prevent and treat problems caused by reduced blood flow to the brain after a subarachnoid hemorrhage (a type of stroke caused by bleeding). It helps protect brain cells from damage during recovery.[2] Nimotop is currently approved and in use across 16 indications[4].[1]

Nimotop is one of 320 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

319

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseActive, not recruiting

StrokeApproved

Brain AneurysmApproved

Cocaine DependenceApproved

Cerebrovascular DisorderApproved

Muscle CrampApproved

Alcohol AbuseApproved

Vestibular SchwannomaApproved

UltrasoundActive, not recruiting

Vascular DiseaseActive, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

StrokeApproved

Approved

Brain AneurysmApproved

Approved

Cocaine DependenceApproved

Approved

Cerebrovascular DisorderApproved

Approved

Muscle CrampApproved

Approved

Alcohol AbuseApproved

Approved

Vestibular SchwannomaApproved

Approved

UltrasoundPhase 1

Active, not recruiting

Vascular DiseasePreclinical

Active, not recruiting

Showing 10 of 16 indications

Competition

Competitive Landscape

150 competitors in Stroke

#DrugCompanyPhaseTrials

Nimotop

AAzurity Pharmaceuticals

Approved

28 2

Zometa

Pfizer

Preclinical

1 3

Savella

AbbVie

Preclinical

1 4

Proamatine

Repatha

Zantac 150

1 7

Periactin

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 8

Alka-Seltzer

AAbbott

Preclinical

1 9

Haldol

DDePuy Orthopaedics

Preclinical

1 10

Anticoagulant

Bayer

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Humans

NCT06998368

Q1 2027

PreclinicalRecruiting

Colectomy

NCT07048522

Q2 2032

Phase 2Not yet recruiting

Alcohol Drinking

NCT06900998

Phase 2Not yet recruiting

Alcohol Use Disorder

NCT07681869

Clinical

Trials by Indication[1]

Treatment3 trials

High Dose Nimodipine Treatment Adjunct - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000332

Dose Finding Study of Nimodipine for the Treatment of Progranulin Insufficiency From GRN Gene Mutations

Completed·UUniversity of California, San Francisco·Phase 1·NCT01835665·8 enrolled

RCVS: The Rational Approach to Diagnosis and Treatment

Withdrawn·JJohns Hopkins University·Phase 4·NCT03150524

Subarachnoid Hemorrhage3 trials

Safety and Tolerability Study of EG-1962 in Aneurysmal Subarachnoid Hemorrhage

Completed·EEdge Therapeutics Inc·Phase 1/2·NCT01893190·73 enrolled

Carbonic Anhydrase Antagonism in Subarachnoid Hemorrhage

Withdrawn·UUniversity of Florida·Phase 2·NCT02165644

Management of Cerebral Vascular Spasm in Posttraumatic Subarachnoid Hemorrhage Using Combination Therapy

Completed·ZZagazig University·Phase 2·NCT05131867·30 enrolled

Ultrasound1 trial

Pharmacological Mechanisms of Low-intensity Focused Ultrasound for Motor Cortex Neuroplasticity

Active, not recruiting·UUniversity Health Network, Toronto·Phase 1·NCT04923659·20 enrolled

Cocaine Abuse1 trial

Glutaminergic Agents for Cocaine Abuse - 5

Completed·YYale University·Phase 1·NCT00000280

Stellate Ganglion Block1 trial

Stellate Ganglion Block as Adjuvant Therapy to ca Channel Blocker

Completed·—·Phase 2·NCT04100824·40 enrolled

19 more indications

Alcohol Drinking1 trial

Pilot Study: Effects of Nimodipine on Alcohol Drinking

Not yet recruiting·YYale University·Phase 2·NCT06900998·5 enrolled

Cognitive impairment1 trial

Efficacy and Safety Study of Nimodipine to Prevent Mild Cognitive Impairment After Acute Ischemic Strokes

Unknown status·MMinistry of Science and Technology of the People´s Republic of China·Phase 4·NCT01220622·656 enrolled

Ovulation Induction1 trial

Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT

Completed·BBoston IVF·N/A·NCT01672801·18 enrolled

Cerebral Infarction1 trial

Nimodipine for Treating Acute Massive Cerebral Infarction

Completed·FFengtian Hospital·Phase 4·NCT02248233·72 enrolled

Terminated·UUniversity of Pittsburgh·Phase 4·NCT00781326·9 enrolled

Cognition1 trial

The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00814658·22 enrolled

Poisoning1 trial

Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning

Completed·UUniversity of Edinburgh·Phase 3·NCT03925025·1,728 enrolled

MPA1 trial

Bioavailability Comparison Study of Two Types of Nimodipine Injections in Healthy Volunteers

Unknown status·SShenyang Dongxing Pharmaceutical Technology Co., Ltd.·Phase 1·NCT03794843·26 enrolled

Intravenous1 trial

Relative Bioavailability of Intravenous GTX-104 Compared to Oral Nimodipine Capsules in Healthy Subjects

Completed·GGrace Therapeutics Inc.·Phase 1·NCT05418348·58 enrolled

Humans1 trial

A Causal Role for Voltage-gated Cav1.2 Calcium Channels in Mediating 5G FR1 Effects on Sleep-associated Brain Health in Humans

Recruiting·HHans-Peter Landolt·N/A·NCT06998368·30 enrolled

Schizophrenia1 trial

Cognitive Effects of Nimodipine in Patients With Schizophrenia

Completed·JJohns Hopkins University·Phase 1·NCT03671525·18 enrolled

Infertility1 trial

Use of a Calcium Channel Blocker to Prevent Premature Luteinizing Hormone Surges in Infertility Patients

Terminated·MMount Sinai Hospital, Canada·Phase 2·NCT01551368·12 enrolled

Preeclampsia1 trial

Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia

Completed·FFDA Office of Orphan Products Development·N/A·NCT00004399·2,000 enrolled

Concentration1 trial

Cerebral Nimodipine Concentrations Following Oral, Intra-venous and Intra-arterial Administration

Unknown status·MMedical University of Vienna··NCT04649398·30 enrolled

Colectomy1 trial

Perioperative Nimodipine for Intra- and Postoperative Pain Management and Reduction of Anesthetic Requirements in Patients Undergoing Open Colectomy: a Prospective, Double-blind, Randomized Controlled Trial

Recruiting·UUniversity of Ioannina·Preclinical·NCT07048522·40 enrolled

Alcohol Use Disorder1 trial

A Randomized Controlled Study on the Effects of Nimodipine on Alcohol Drinking Among Adults Who Are Heavy Alcohol Drinkers

Not yet recruiting·YYale University·Phase 2·NCT07681869·40 enrolled

Unspecified1 trial

Nimodipine in Vestibular Schwanommas

Unknown status·MMedical University of Vienna·Phase 2·NCT04801953·30 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 28, 1988

NIMOTOP

NDA NDA018869

May 10, 2013

NYMALIZE

NDA NDA203340

Sources

References

[1]
ClinicalTrials.gov — 28 trial records for Nimodipine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Nimotop drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Nimodipine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Nimodipine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA203340). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Nimotop. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Azurity Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Mineralocorticoid Receptor Antagonist; Voltage-Gated L-Type Calcium Channel Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAzurity Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Apr 16, 2038

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11413277Apr 16, 2038

12186308Apr 16, 2038

10342787Apr 16, 2038

10576070Apr 16, 2038

11207306Apr 16, 2038

1 more patents

11806338Apr 16, 2038

Nimotop

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2032

Trials by Indication[1]

Treatment3 trials

Subarachnoid Hemorrhage3 trials

Ultrasound1 trial

Cocaine Abuse1 trial

Stellate Ganglion Block1 trial

Alcohol Drinking1 trial

Cognitive impairment1 trial

Ovulation Induction1 trial

Cerebral Infarction1 trial

Double-blind1 trial

Vascular Disease1 trial

Effectiveness1 trial

Cognition1 trial

Poisoning1 trial

MPA1 trial

Intravenous1 trial

Humans1 trial

Schizophrenia1 trial

Infertility1 trial

Preeclampsia1 trial

Concentration1 trial

Colectomy1 trial

Alcohol Use Disorder1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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