FDA Events for Evoke Pharma (EVOK)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Evoke Pharma (EVOK).
Over the past two years, Evoke Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
GIMOTI. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
GIMOTI (metoclopramide) nasal spray - FDA Regulatory Timeline and Events
GIMOTI (metoclopramide) nasal spray is a drug developed by Evoke Pharma for the following indication: Acute and recurrent diabetic gastroparesis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- GIMOTI (metoclopramide) nasal spray
- Announced Date:
- July 9, 2025
- Indication:
- Acute and recurrent diabetic gastroparesis
Announcement
Evoke Pharma, Inc. announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a U.S. patent application covering the use of GIMOTI® in patients with moderate to severe symptoms of gastroparesis.
AI Summary
Evoke Pharma, Inc. announced that it has received a Notice of Allowance from the USPTO for a U.S. patent application covering the use of GIMOTI® (metoclopramide) in patients with moderate to severe symptoms of gastroparesis. This patent, a continuation of U.S. Patent No. 11,517,545, expands the company’s intellectual property around the intranasal use of metoclopramide and is expected to expire in December 2036.
The company plans to list the patent in the FDA’s Orange Book, which could extend market exclusivity for GIMOTI® beyond existing patents. According to CEO Matt D’Onofrio, this new patent allowance provides additional protection by defining how and in which patients the therapy is used. This development reinforces GIMOTI®’s role as a unique non-oral treatment option, particularly beneficial for patients whose condition results in unpredictable absorption of oral medications.
Read Announcement
Evoke Pharma FDA Events - Frequently Asked Questions
As of now, Evoke Pharma (EVOK) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Evoke Pharma (EVOK) has reported FDA regulatory activity for GIMOTI (metoclopramide) nasal spray.
The most recent FDA-related event for Evoke Pharma occurred on July 9, 2025, involving GIMOTI (metoclopramide) nasal spray. The update was categorized as "Notice of Allowance," with the company reporting: "Evoke Pharma, Inc. announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a U.S. patent application covering the use of GIMOTI® in patients with moderate to severe symptoms of gastroparesis."
Currently, Evoke Pharma has one therapy (GIMOTI (metoclopramide) nasal spray) targeting the following condition: Acute and recurrent diabetic gastroparesis.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:EVOK) was last updated on 7/10/2025 by MarketBeat.com Staff
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