dronabinol (VER-01) / Vertanical - LARVOL DELTA

Dose-Response Characterization of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain (clinicaltrials.gov) - P2 | N=652 | Completed | Sponsor: Vertanical GmbH | Active, not recruiting ➔ Completed

Trial completion • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

EXPAND: Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Low Back Pain (clinicaltrials.gov) - P3 | N=700 | Not yet recruiting | Sponsor: Vertanical GmbH | Trial completion date: May 2027 ➔ Sep 2027 | Initiation date: Nov 2025 ➔ Mar 2026 | Trial primary completion date: May 2027 ➔ Sep 2027

Trial completion date • Trial initiation date • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Dose-Response Characterization of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain (clinicaltrials.gov) - P2 | N=652 | Active, not recruiting | Sponsor: Vertanical GmbH | N=1200 ➔ 652

Enrollment change • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

EXPAND: Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Low Back Pain (clinicaltrials.gov) - P3 | N=700 | Not yet recruiting | Sponsor: Vertanical GmbH

New P3 trial • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Dose-Response Characterization of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain (clinicaltrials.gov) - P2 | N=1200 | Active, not recruiting | Sponsor: Vertanical GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Dose-Response Characterization of VER-01 in the Treatment of Patients with Chronic Non-specific Low Back Pain (clinicaltrials.gov) - P2 | N=1200 | Recruiting | Sponsor: Vertanical GmbH | N=800 ➔ 1200 | Trial completion date: Jul 2025 ➔ Oct 2025 | Trial primary completion date: Jul 2025 ➔ Oct 2025

Enrollment change • Trial completion date • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

ELEVATE: Comparison of VER-01 to Opioids in Patients With Chronic Non-specific Low Back Pain (clinicaltrials.gov) - P3 | N=384 | Completed | Sponsor: Vertanical GmbH | Active, not recruiting ➔ Completed

Trial completion • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Dose-Response Characterization of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain (clinicaltrials.gov) - P2 | N=800 | Recruiting | Sponsor: Vertanical GmbH | Not yet recruiting ➔ Recruiting

Enrollment open • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Dose-Response Characterization of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain (clinicaltrials.gov) - P2 | N=800 | Not yet recruiting | Sponsor: Vertanical GmbH

New P2 trial • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain (clinicaltrials.gov) - P3 | N=820 | Completed | Sponsor: Vertanical GmbH | Recruiting ➔ Completed | Trial primary completion date: Oct 2023 ➔ Mar 2024

Trial completion • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

ELEVATE: Comparison of VER-01 to Opioids in Patients With Chronic Non-specific Low Back Pain (clinicaltrials.gov) - P3 | N=384 | Active, not recruiting | Sponsor: Vertanical GmbH | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Mar 2025 ➔ Dec 2024 | Trial primary completion date: Aug 2024 ➔ Dec 2024

Enrollment closed • Trial completion date • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain (clinicaltrials.gov) - P3 | N=808 | Recruiting | Sponsor: Vertanical GmbH | Trial completion date: Dec 2023 ➔ May 2024 | Trial primary completion date: Jun 2023 ➔ Oct 2023

Trial completion date • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

VER-PK-002: Food Effect Study of VER-01 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Vertanical GmbH | Recruiting ➔ Completed | Trial completion date: Apr 2023 ➔ Nov 2022

Trial completion • Trial completion date

ELEVATE: Comparison of VER-01 to Opioids in Patients With Chronic Non-specific Low Back Pain (clinicaltrials.gov) - P3 | N=350 | Not yet recruiting | Sponsor: Vertanical GmbH

New P3 trial • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

VER-PK-002: Food Effect Study of VER-01 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Vertanical GmbH | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2022 ➔ Apr 2023 | Trial primary completion date: May 2022 ➔ Nov 2022

Enrollment open • Trial completion date • Trial primary completion date

VER-PK-001: Single and Multiple Dose Study of VER-01 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Vertanical GmbH | Recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Jul 2022

Trial completion • Trial completion date