FDA Grants Fast Track Status to FRP-003 for Long COVID Ahead of Phase 2 Study

The FDA has granted fast track designation to FRP-003, an investigational, orally administered botanical drug candidate from Front Range Pharmaceuticals, for the treatment of Long COVID. The agency’s Division of Rheumatology and Transplant Medicine issued the designation 1 month after clearing the company’s investigational new drug application for a phase 2 trial in approximately 220 adults with long COVID and persistent fatigue.^1,2

"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," David Putrino, PhD, Nash Family Director of the Cohen Center for Recovery From Complex Chronic Illnesses at Mount Sinai, said in a statemenet.¹

"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,” Putrino, who also serves as a professor of rehabilitation and human performance at the Icahn School of Medicine at Mount Sinai, said in a statement.¹

Regulatory Pathway and Phase 2 Trial Design

The multicenter, randomized, double-blind, placebo-controlled phase 2 study will enroll adults aged 18 to 65 years with fatigue-predominant Long COVID, accompanied by post-exertional malaise (PEM) and reduced daily functioning. Participants will be randomized 1:1:1 to 1 of 2 fixed doses of FRP-003 or placebo, taken orally twice daily for 56 days.²

The primary end point is change from baseline to day 56 in PROMIS Fatigue Short Form 8a T-score, with approximately 90% power to detect a clinically meaningful difference. Secondary end points include fatigue responder rate, sleep disturbance, and anxiety; exploratory end points include cognition and inflammatory biomarkers. An independent data monitoring committee will review unblinded safety data. Enrollment is expected to begin in 2027 and take approximately 12 months.

Clinical Context

Long COVID is a chronic, multisystem condition with an estimated cumulative global incidence of 400 million. Its fatigue, PEM, cognitive impairment, and autonomic dysfunction overlap substantially with myalgic encephalomyelitis/chronic fatigue syndrome. Management remains largely symptomatic.³

READ MORE: FDA Grants Fast Track to AV-1959R for Alzheimer Prevention

“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,” Suzanne Vernon, PhD, chief clinical officer at Front Range Pharmaceuticals, said in a statement.¹ “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.”

FRP-003 Background and Prior Data

The IND drew on prior human experience, including a randomized study of 31 participants with post-COVID symptoms (NCT04828668) and a 12-week open-label study of 14 participants, with no serious adverse events reported.² The published randomized study evaluated Formula C, a cannabidiol-rich, terpene-rich whole-flower preparation, in a single-blind crossover design.⁴ Scores improved in both groups at day 28, and reanalysis found the placebo contained unexpected terpene concentrations, leaving no true placebo. The company acknowledged both studies were small and not designed to establish safety or efficacy.²

"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," Isaac Foster, chief executive officer at Front Range Pharmaceuticals, said in a statement.¹ "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."

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REFERENCES
1. Front Range Pharmaceuticals receives FDA fast track designation for FRP-003 in long COVID. Business Wire. November 6, 2026. https://www.businesswire.com/news/home/20261106110330/en/Front-Range-Pharmaceuticals-Receives-FDA-Fast-Track-Designation-for-FRP-003-in-Long-COVID
2. Front Range Pharmaceuticals announces FDA clearance to initiate phase 2 trial of FRP-003 in long COVID. News release. Front Range Pharmaceuticals; October 6, 2026. Accessed November 11, 2026. https://www.businesswire.com/news/home/20261006387219/en/Front-Range-Pharmaceuticals-Announces-FDA-Clearance-to-Initiate-Phase-2-Trial-of-FRP-003-in-Long-COVID
3. Al-Aly Z, Davis H, McCorkell L, et al. Long COVID science, research and policy. Nat Med. 2024;30(8):2148-2164. doi:10.1038/s41591-024-03173-6
4. Young TP, Erickson JS, Hattan SL, Guzy S, Hershkowitz F, Steward MD. A single-blind, randomized, placebo controlled study to evaluate the benefits and safety of Endourage Targeted Wellness Formula C sublingual drops in people with post-acute COVID-19 syndrome. Cannabis Cannabinoid Res. 2024;9(1):282-292. doi:10.1089/can.2022.0135