FDA grants Fast Track designation to Front Range Pharmaceuticals' FRP-003 for Long COVID

What's the deal? On 6 November 2026, Front Range PharmaceuticalsDealroom has a profile for this one. Try Dealroom →, a Colorado-based clinical-stage company developing standardised botanical (plant-derived) medicines, announced that the US Food and Drug Administration (FDA) granted Fast Track designation to FRP-003, its investigational oral drug candidate for Long COVID — the persistent fatigue and other symptoms that can continue for months after a COVID-19 infection. The designation was issued on 30 October 2026 following the FDA's earlier clearance of the company's investigational new drug application for a Phase 2 trial in Long COVID.

Why it matters: Fast Track is a US programme designed to speed up development and review of drugs that address serious conditions with unmet medical need. It gives the company more frequent communication with the FDA, rolling review of its marketing application, and eligibility for Accelerated Approval and Priority Review if criteria are met. The planned Phase 2 trial is a randomised, double-blind, placebo-controlled study in approximately 220 adults with Long COVID and persistent fatigue, with change in fatigue severity at day 56 as the primary endpoint; enrolment is expected to begin in 2027. FRP-003 is not yet approved by the FDA or any other regulator.

Read more: Business Wire, 6 November 2026