Evoke Pharma's Drug in the FDA Approval Process
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:
- August 26, 2025
- Indication:
- Acute and recurrent diabetic gastroparesis
Announcement
Evoke Pharma, Inc together with EVERSANA, a leading provider of global commercial services to the life sciences industry, today announced the addition of Omnicell
AI Summary
Evoke Pharma, together with EVERSANA, announced the addition of Omnicell as a distribution partner for GIMOTI nasal spray. Omnicell will handle order processing, storage and delivery to hospital outpatient pharmacies, helping more patients access the treatment.
With this partnership, Evoke will leverage Omnicell’s medication management platform to support accurate ordering, expiration tracking and faster delivery. Hospital and clinic pharmacies can better manage inventory levels and reduce waste, ensuring a reliable supply of GIMOTI.
The move strengthens Evoke’s plan to make GIMOTI widely available across the United States. By working closely with EVERSANA and Omnicell, Evoke will benefit from seamless integration with electronic health records, real-time supply monitoring and enhanced patient support services.
EVERSANA’s team will coordinate marketing, sales and patient support, ensuring providers have training and reimbursement assistance. Omnicell’s network covers over 1,000 hospital outpatient pharmacies, streamlining orders and reducing delays for patients needing this non-oral treatment.
Read Announcement- Drug:
- GIMOTI (metoclopramide) nasal spray
- Announced Date:
- August 21, 2025
- Indication:
- Acute and recurrent diabetic gastroparesis
Announcement
Evoke Pharma, Inc. announced that U.S. Patent No. 12,377,064 covering the use of GIMOTI® (metoclopramide) nasal spray in patients with moderate to severe symptoms of gastroparesis, has been listed in the U.S. Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the "Orange Book".
AI Summary
Evoke Pharma, Inc. announced that U.S. Patent No. 12,377,064 covering the use of GIMOTI® (metoclopramide) nasal spray for moderate to severe gastroparesis has been listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, known as the “Orange Book.” This patent listing recognizes the spray’s approved therapeutic equivalence and secures its protection until November 17, 2038.
CEO Matt D’Onofrio said this listing shows Evoke’s commitment to innovation and highlights their hard work in expanding treatment options. The new patent extends exclusivity roughly eight years beyond their prior Orange Book entry, helping safeguard their investment in developing a non‐oral treatment for diabetic gastroparesis.
By listing this patent in the Orange Book, Evoke aims to maintain GIMOTI’s commercial life and ensure patient access to a nasal metoclopramide spray that bypasses the stomach. This move underlines their strategy to protect valuable intellectual property and support continued availability of an effective GI therapy.
Read Announcement- 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 August 26, 2025, involving GIMOTI (metoclopramide) nasal spray. The update was categorized as "Provided Update," with the company reporting: "Evoke Pharma, Inc together with EVERSANA, a leading provider of global commercial services to the life sciences industry, today announced the addition of Omnicell"
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 10/9/2025 by MarketBeat.com Staff
