TheraRadar
Data updated: May 26, 2026

NYMALIZE (nimodipine)

Trial Activity: Declining 1 active trials
Cardiovascular Approved 2013-05-10
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Yale University conducting 1 trials (8%)
17 indications explored (Broad Platform)
→ alcohol use disorder (1 trials)
→ anticholinesterase insecticide poisoning (1 trials)
→ pesticide poisoning (1 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
13
Years on Market

Details

Status
Discontinued
First Approved
2013-05-10
Patent Cliff
2038

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
SOLUTION

Companies

AZURITY
Active Ingredient: NIMODIPINE

NYMALIZE Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
16 FDA actions from 2013 to 2024
Aug 2024 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Dec 2020 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Apr 2020 SUPPL
Mfg · Manufacturing (CMC)
Label

What NYMALIZE Treats

1 FDA approvals

Originally approved for its first indication in 2013 .

  • Other (1)
📋

Clinical Trial Registry

12 trials
Trial Sponsor ID Phase Status Title
NCT06900998 2000038566 2P50AA012870-21 Ph 2 not yet recruiting Pilot Study: Effects of Nimodipine on Alcohol Drinking
NCT03925025 CCBOC AC19003 Ph 3 completed Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning
NCT04100824 stellate ganglion block Ph 2 completed Stellate Ganglion Block as Adjuvant Therapy to ca Channel Blocker
NCT05131867 6919 Ph 2 completed Management of Cerebral Vascular Spasm in Posttraumatic Subarachnoid Hemorrhage Using Combination Therapy
NCT03150524 IRB00130191 Ph 4 withdrawn RCVS: The Rational Approach to Diagnosis and Treatment
NCT01551368 nimodipine 09-0175-A Ph 2 terminated Use of a Calcium Channel Blocker to Prevent Premature Luteinizing Hormone Surges in Infertility Patients
NCT02248233 FengtianH-RHL-001 Ph 4 completed Nimodipine for Treating Acute Massive Cerebral Infarction
NCT01893190 NEWTON EG-01-1962-02 2013-000954-23 Ph 1, Ph 2 completed Safety and Tolerability Study of EG-1962 in Aneurysmal Subarachnoid Hemorrhage
NCT00781326 results posted K23MH067710-01 K23MH067710-01, DATR AK-TNGP1 Ph 4 terminated Effectiveness of Nimodipine Plus Antidepressant Medication in Treating Vascular Depression
NCT01835665 CHR12-09098 Ph 1 completed Dose Finding Study of Nimodipine for the Treatment of Progranulin Insufficiency From GRN Gene Mutations
NCT02165644 2014000419 Ph 2 withdrawn Carbonic Anhydrase Antagonism in Subarachnoid Hemorrhage
NCT00814658 results posted CR014938 GALDEM4008 Ph 4 completed The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

NYMALIZE FDA Label Details

View full patent landscape →
6 OB patents · 1 families · 14 international docs across 1 countries

NYMALIZE Patents & Exclusivity

Latest Patent: Apr 2038

Patents (6 active)

US11413277 Expires Apr 16, 2038
US12186308 Expires Apr 16, 2038
US10342787 Expires Apr 16, 2038
US10576070 Expires Apr 16, 2038
US11207306 Expires Apr 16, 2038
US11806338 Expires Apr 16, 2038
Source: FDA Orange Book

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Deep insights for NYMALIZE

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2038
  • • 12 active patents

Trial Analysis

  • • 12 total trials
  • • Stage: Declining

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA203340 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment