Policy & Regulation
Latigo Biotherapeutics' LTG-001 receives US FDA Fast Track designation
4 March 2025 -

Clinical-stage biotechnology company Latigo Biotherapeutics announced on Monday that it has received Fast Track designation (FTD) from the US Food and Drug Administration (FDA) for LTG-001 for the treatment of acute pain.

LTG-001 is an oral, investigational selective inhibitor of Nav1.8, a key sodium channel involved in pain signalling. LTG-001 works by blocking peripheral sensory neurons responsible for pain signals, thus preventing the transmission of these pain signals to the central nervous system.

The FTD follows positive Phase 1 results which demonstrated a favourable safety, tolerability and pharmacokinetic profile for LTG-001.

Latigo CEO Nima Farzan said: "We are pleased the FDA has granted Fast Track designation to LTG-001, recognising its potential to transform the treatment landscape for acute pain by targeting pain at its source. This marks an important milestone for Latigo and reinforces the promise of LTG-001 as a highly selective, well-tolerated non-opioid approach for treating pain. With this designation, we look forward to working closely with the FDA to accelerate development and bring this much-needed non-opioid medicine to patients rapidly."

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