Front Range Pharmaceuticals (“Front Range”) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to FRP-003, the company’s investigational drug candidate, for the treatment of Long COVID. FDA’s Division of Rheumatology and Transplant Medicine issued the designation on October 30, 2026, under the company’s investigational new drug application (IND 182511).

In its letter, FDA stated that the company’s request, submitted on August 31, 2026, “meets the criteria for the Fast Track designation.” The designation came one month after FDA notified the company, on September 30, 2026, that its Phase 2 study of FRP-003 may proceed.

Highlights

  • FDA granted Fast Track designation to FRP-003 for Long COVID on October 30, 2026.

  • Fast Track makes a development program eligible for more frequent communication with FDA and, if relevant criteria are met, for rolling review of a future marketing application, Priority Review and Accelerated Approval.

  • Front Range is preparing to initiate its FDA-cleared Phase 2 trial of FRP-003 in Long COVID, with enrollment expected to begin in 2027.

  • The randomized, double-blind, placebo-controlled Phase 2 trial will enroll approximately 220 adults with Long COVID and persistent fatigue; the primary endpoint is change in fatigue severity at Day 56.

Management Commentary

“Millions of people living with Long COVID continue to experience debilitating symptoms that profoundly affect their health, daily functioning, and quality of life, yet there are no FDA-approved treatments,” said Suzanne Vernon, PhD, Chief Clinical Officer of Front Range Pharmaceuticals. “Fast Track designation recognizes the significant unmet medical need and provides an important opportunity to work more closely with FDA as we advance FRP-003 through clinical development. Our immediate priority is to launch a rigorous Phase 2 trial to determine whether FRP-003 can meaningfully reduce fatigue and improve daily functioning in people living with Long COVID.”

“Receiving Fast Track designation within weeks of our IND clearance is a credit to Dr. Vernon and our clinical and regulatory teams, who built a well-defined development program,” said Isaac Foster, Chief Executive Officer of Front Range Pharmaceuticals. “I also want to thank our partners: Steve Pondell of IBT Solutions, who guided our chemistry, manufacturing and controls (CMC) work, and Michelle Wawrzyniak and the team at Tranquil Clinical and Research Consulting Services, who led our IND application. I’m also grateful to our investors, C&A Companies and the Blain family, for their faith and support. We look forward to working closely with FDA as the program advances.”

“It is estimated that more than 400 million people around the world have experienced Long COVID, and this number continues to grow with repeated infection,” said David Putrino, PhD, Nash Family Director of the Cohen Center for Recovery From Complex Chronic Illnesses at Mount Sinai and Professor of Rehabilitation and Human Performance at the Icahn School of Medicine at Mount Sinai. “Their symptoms are severe and debilitating, yet there are still no FDA-approved treatments for this diagnosis. Patients need solutions today, and that means rigorous clinical trials of new therapies. FDA programs like Fast Track, which are designed to speed the development of treatments for serious conditions, matter to this community.”

Dr. Putrino is not affiliated with Front Range Pharmaceuticals.

The Phase 2 Trial

On October 6, 2026, Front Range announced that FDA had cleared its IND to initiate a Phase 2 clinical trial of FRP-003 in Long COVID. The multicenter, randomized, double-blind, placebo-controlled study will enroll approximately 220 adults aged 18 to 65 with Long COVID and persistent, clinically meaningful fatigue as the predominant symptom, accompanied by post-exertional malaise and reduced daily functioning. Participants will be randomized 1:1:1 to one of two fixed doses of FRP-003 or matching placebo, taken by mouth twice daily for 56 days. To preserve blinding, placebo participants are assigned to volumes matching each dose and are analyzed as a single placebo group. The primary endpoint is the change from baseline to Day 56 in fatigue severity, measured by the PROMIS® Fatigue Short Form 8a T-score. An independent Data Monitoring Committee will periodically review unblinded safety data. The study will be registered on ClinicalTrials.gov before enrollment begins.

Next Steps

Front Range is preparing to initiate its Phase 2 trial of FRP-003 in Long COVID. Enrollment is expected to begin in 2027 and to take approximately 12 months. Front Range will make its expanded access policy for FRP-003 publicly available on its website, as required under section 561A(f) of the Federal Food, Drug, and Cosmetic Act.

About Fast Track Designation

FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. A Fast Track product may be eligible for:

  • More frequent meetings and written communication with FDA about the drug’s development plan, trial design and use of biomarkers

  • Rolling review, which allows a company to submit completed sections of a New Drug Application (NDA) for review rather than waiting until every section is complete

  • Accelerated Approval and Priority Review, if relevant criteria are met

Fast Track designation does not mean FDA has approved FRP-003 or determined that it is safe or effective. FDA’s letter notes that if the clinical development program does not continue to demonstrate that the product meets the Fast Track criteria, the application will not be reviewed under the program.

About Long COVID

Long COVID is a chronic condition in which symptoms continue, return or begin after a SARS-CoV-2 infection and last for months or years. Common symptoms include fatigue, post-exertional malaise, cognitive impairment (“brain fog”), shortness of breath, sleep disturbance and autonomic dysfunction, a pattern that overlaps with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The condition can limit a person’s ability to work, attend school and carry out daily activities. Long COVID affects millions of adults in the United States, and there are no FDA-approved treatments for the condition.

About FRP-003

FRP-003 is an investigational, orally administered botanical drug candidate being developed for the treatment of Long COVID in accordance with FDA’s Botanical Drug Development guidance. FRP-003 is not approved by FDA or any other regulatory authority, and its safety and efficacy have not been established.

About Front Range Pharmaceuticals

Front Range Pharmaceuticals, based in the Denver, Colorado area, is a clinical-stage pharmaceutical company developing standardized botanical drug candidates for conditions with significant unmet medical need. The company’s pipeline includes programs in Long COVID and other neurological, psychiatric and inflammatory conditions. Its lead investigational candidate, FRP-003, has received FDA Fast Track designation for Long COVID. For more information, visit www.frontrangepharmaceuticals.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements about the development of FRP-003, the anticipated timing of the initiation and enrollment of the Phase 2 trial, the potential benefits of Fast Track designation, and potential future regulatory interactions and submissions. Words such as “expect,” “plan,” “potential,” “may,” “will” and similar expressions identify forward-looking statements. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially.

These risks include, among others: Fast Track designation may not lead to a faster development, review or approval process, and does not increase the likelihood that FRP-003 will be approved; FDA may withdraw Fast Track designation if FRP-003 no longer meets the qualifying criteria; the Phase 2 trial may be delayed by site activation, enrollment or other factors; results of the Phase 2 trial may not support further development; FRP-003 may not demonstrate safety or efficacy sufficient for regulatory approval; and regulatory requirements may change. Forward-looking statements speak only as of the date of this release, and Front Range undertakes no obligation to update them except as required by law.

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