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The FDA has granted Fast Track designation to FRP-003, an oral botanical drug from Front Range Pharmaceuticals, for treating Long COVID — a condition affecting an estimated 400 million people worldwide with zero approved treatments. The designation paves the way for a Phase 2 trial enrolling ~220 adults with fatigue-predominant Long COVID, set to kick off in 2027. This marks a meaningful step toward addressing one of medicine's most stubborn unmet needs.
The FDA has granted Fast Track designation to FRP-003, an investigational oral botanical drug candidate developed by Front Range Pharmaceuticals, for the treatment of Long COVID. The designation — issued by the FDA's Division of Rheumatology and Transplant Medicine — came just one month after the agency cleared the company's investigational new drug (IND) application, signaling regulatory momentum for a condition that still has no approved treatments.
The move sets the stage for a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial enrolling approximately 220 adults aged 18–65 with fatigue-predominant Long COVID, post-exertional malaise (PEM), and reduced daily functioning. Participants will be randomized 1:1:1 to one of two doses of FRP-003 or placebo, taken orally twice daily for 56 days. Enrollment is expected to begin in 2027.
Key Takeaways:
Why it matters: With over 400 million people globally estimated to have experienced Long COVID — and symptoms ranging from debilitating fatigue to cognitive impairment — the lack of FDA-approved therapies represents a significant gap in care. Fast Track status enables closer FDA collaboration and could accelerate the path to approval if Phase 2 results are promising.
