Evoke Pharma (EVOK) FDA Events

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 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.

Notice of Allowance - July 9,2025

• Drug: GIMOTI (metoclopramide) nasal spray
• Announced Date: July 9, 2025
• Indication: Acute and recurrent diabetic gastroparesis

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.

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.

Evoke Pharma FDA Events - Frequently Asked Questions

Has Evoke Pharma received FDA approval?

As of now, Evoke Pharma (EVOK) has not received any FDA approvals for its therapy in the last two years.

What drugs has Evoke Pharma submitted to the FDA?

In the past two years, Evoke Pharma (EVOK) has reported FDA regulatory activity for GIMOTI (metoclopramide) nasal spray.

What is the most recent FDA event for Evoke Pharma?

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."

What conditions do Evoke Pharma's current drugs treat?

Currently, Evoke Pharma has one therapy (GIMOTI (metoclopramide) nasal spray) targeting the following condition: Acute and recurrent diabetic gastroparesis.