LTG-001 / Latigo Biotherap - LARVOL DELTA

A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants (clinicaltrials.gov) - P1 | N=96 | Active, not recruiting | Sponsor: Latigo Biotherapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2025 ➔ Feb 2026 | Trial primary completion date: Jul 2025 ➔ Feb 2026

Enrollment closed • Trial completion date • Trial primary completion date

LTG-001-003: This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars (clinicaltrials.gov) - P2 | N=250 | Active, not recruiting | Sponsor: Latigo Biotherapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Pain

An Efficacy and Safety Study of LTG-001 Following Abdominoplasty (clinicaltrials.gov) - P2 | N=360 | Recruiting | Sponsor: Latigo Biotherapeutics

New P2 trial • Aesthetic Medicine • Pain

LTG-001-003: This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars (clinicaltrials.gov) - P2 | N=250 | Completed | Sponsor: Latigo Biotherapeutics | Active, not recruiting ➔ Completed

Trial completion • Pain

A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Latigo Biotherapeutics | Trial completion date: Feb 2025 ➔ Sep 2025 | Trial primary completion date: Feb 2025 ➔ Jul 2025

Trial completion date • Trial primary completion date

LTG-001-003: This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars (clinicaltrials.gov) - P2 | N=250 | Recruiting | Sponsor: Latigo Biotherapeutics | Trial completion date: May 2025 ➔ Aug 2025 | Trial primary completion date: Apr 2025 ➔ Jul 2025

Trial completion date • Trial primary completion date • Pain

Latigo Biotherapeutics Granted FDA Fast Track Designation for LTG-001, Potential Best-in-Class Nav1.8 Inhibitor for the Non-Opioid Treatment of Acute Pain (PRNewswire) - "Latigo Biotherapeutics...today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to LTG-001, the company's oral, investigational selective Nav1.8 inhibitor for the treatment of acute pain....The FTD follows positive Phase 1 results which demonstrated a favorable safety, tolerability, and pharmacokinetic profile for LTG-001."

Fast track • Pain

This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Latigo Biotherapeutics

New P2 trial • Pain

A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Latigo Biotherapeutics | Trial completion date: May 2024 ➔ Feb 2025 | Trial primary completion date: May 2024 ➔ Feb 2025

Trial completion date • Trial primary completion date

A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Latigo Biotherapeutics | Not yet recruiting ➔ Recruiting

Enrollment open