LTG-001 / Latigo Biotherap - LARVOL DELTA

Phase 2b Trial of a NaV1.8 Inhibitor for Acute Pain. (PubMed, N Engl J Med) - P2 | "LTG-001 led to significantly greater reductions in pain scores than placebo over the course of 48 hours after abdominoplasty. (Funded by Latigo Biotherapeutics; LTG-001-010 ClinicalTrials.gov number, NCT07102459.)."

Clinical • Journal • P2b data • Aesthetic Medicine • Pain • NAV1

A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants (clinicaltrials.gov) - P1 | N=204 | Active, not recruiting | Sponsor: Latigo Biotherapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2026 ➔ Sep 2026 | Trial primary completion date: Apr 2026 ➔ Sep 2026

Enrollment closed • Trial completion date • Trial primary completion date

Efficacy and Safety of LTG-001, a Selective NaV1.8 Inhibitor, in Patients with Moderate to Severe Pain after Abdominoplasty (AAN 2026) - "Participants were randomized 1:1:1:1 to oral LTG-001 high dose (450mg loading +300mg q12h; n=86), low dose (300mg loading +150mg q12h; n=85), hydrocodone/acetaminophen 5/325mg q6h (opioid reference; n=86), or placebo (n=86) for 48 h; oxycodone 5mg q6h was permitted as rescue... LTG-001 produced rapid, robust analgesia after abdominoplasty with favorable tolerability and significant opioid sparing. Placebo-adjusted 48-hour effect for high-dose LTG-001 (62.1) was the largest of any analgesic tested in abdominoplasty in a published industry-sponsored trial."

Clinical • Aesthetic Medicine • Pain • NAV1

LTG-001-015: An efficacy and safety study of LTG-001 in osteoarthritis (clinicaltrialsregister.eu) - P1/2 | N=180 | Not yet recruiting | Sponsor: Latigo Biotherapeutics Inc.

New P1/2 trial • Immunology • Osteoarthritis • Pain • Rheumatology

A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants (clinicaltrials.gov) - P1 | N=204 | Recruiting | Sponsor: Latigo Biotherapeutics | Active, not recruiting ➔ Recruiting | N=96 ➔ 204

Enrollment change • Enrollment open

A Study Comparing LTG-001 SDD Formulation To LTG-001 Crystalline Immediate Release Tablets In Healthy Participants (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: Latigo Biotherapeutics

New P1 trial • Pain

An Efficacy and Safety Study of LTG-001 Following Abdominoplasty (clinicaltrials.gov) - P2 | N=343 | Completed | Sponsor: Latigo Biotherapeutics | Recruiting ➔ Completed

Trial completion • Aesthetic Medicine • Pain

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