RZL 012 / Raziel Therap, Fosun Pharma - LARVOL DELTA

Raziel and Fosun Pharma (by JuveStar an affiliate company of Fosun Pharma) Initiate Phase 3 Registration Trial in China for Submental Fat Reduction ('double chin') (PRNewswire) - "Raziel Therapeutics, a pharmaceutical company developing next-generation novel prescription products for the medical aesthetics market, announces phase 3 study initiation in China for the treatment of fat reduction in the submental area. Submental fat (SMF) reduction is the first indication for RZL-012 among many potential aesthetic focal fat reduction treatments for body shaping...The product is expected to be launched in China during 2027."

Launch non-US • New P3 trial • Metabolic Disorders • Obesity

RZL-012 for Dercum's Disease Lipomas (clinicaltrials.gov) - P2 | N=38 | Completed | Sponsor: Raziel Therapeutics Ltd. | Phase classification: P2b ➔ P2

Phase classification • Rare Diseases

An Open Label Study That Will Test Safety and Efficacy of RZL-012 Injection Into the Submental Fat in Chinese vs. Non-Chinese Subjects. (clinicaltrials.gov) - P1/2 | N=20 | Completed | Sponsor: Raziel Therapeutics Ltd. | Not yet recruiting ➔ Completed | Trial completion date: Jan 2023 ➔ Jun 2023 | Trial primary completion date: Nov 2022 ➔ May 2023

Trial completion • Trial completion date • Trial primary completion date

Treatment of Women With Lipedema Involving Substantial Fat Knee of Women and Men With Nodular Dercum's Disease (clinicaltrials.gov) - P2 | N=12 | Completed | Sponsor: Raziel Therapeutics Ltd. | Phase classification: P2a ➔ P2

Phase classification • Genetic Disorders • Rare Diseases

A Single Blind, Randomized, Placebo-controlled, Phase 2a, 2-cohort Study for the Evaluation of Safety and Efficacy of RZL-012 for Submental Fat Reduction in Healthy Volunteers. (clinicaltrials.gov) - P2 | N=28 | Completed | Sponsor: Raziel Therapeutics Ltd. | Phase classification: P2a ➔ P2

Phase classification

Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks (clinicaltrials.gov) - P2 | N=12 | Completed | Sponsor: Raziel Therapeutics Ltd. | Active, not recruiting ➔ Completed

Trial completion

An Open-label Study That Will Test a Second Treatment Session of RZL-012. (clinicaltrials.gov) - P2 | N=15 | Completed | Sponsor: Raziel Therapeutics Ltd. | Recruiting ➔ Completed | N=30 ➔ 15

Enrollment change • Trial completion

Tapencarium (RZL-012) for Flank Fat Reduction: A Proof-of-Concept Study. (PubMed, Aesthet Surg J Open Forum) - "The drug was well tolerated in this small patient population, with no concerning safety signals, and it had indications of efficacy. Further research is needed in large Phase 2 studies with robust efficacy measurements to confirm these early findings."

Journal

An Open-label Study That Will Test a Second Treatment Session of RZL-012. (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Raziel Therapeutics Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse Events (clinicaltrials.gov) - P1/2 | N=48 | Completed | Sponsor: Raziel Therapeutics Ltd. | Not yet recruiting ➔ Completed | N=75 ➔ 48

Adverse events • Enrollment change • Trial completion • Anesthesia

Efficacy and Safety of Tapencarium (RZL-012) in Submental Fat Reduction. (PubMed, Aesthet Surg J) - "A single administration of RZL-012 into SMF resulted in significant improvement in submental appearance as assessed by clinicians, subjects and MRI. From a safety perspective, there were no serious AEs nor any clinically significant changes in vital signs or laboratory tests over the course of the study."

Journal

An Open-label Study That Will Test a Second Treatment Session of RZL-012. (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Raziel Therapeutics Ltd.

New P2 trial

Evaluation the Effects of a Local Anesthetic, Anti-inflammatory Medications and Compression Garments on RZL-012-Induced Adverse Events (clinicaltrials.gov) - P1/2 | N=75 | Not yet recruiting | Sponsor: Raziel Therapeutics Ltd.

Adverse events • New P1/2 trial • Anesthesia

An Open Label Study That Will Test Safety and Efficacy of RZL-012 Injection Into the Submental Fat in 10 Chinese vs. 10 Non-Chinese Subjects. (clinicaltrials.gov) - P1/2 | N=20 | Not yet recruiting | Sponsor: Raziel Therapeutics Ltd.

New P1/2 trial

Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks (clinicaltrials.gov) - P2 | N=12 | Active, not recruiting | Sponsor: Raziel Therapeutics Ltd.

New P2 trial

Efficacy and Safety of RZL-012 on Submental Fat Reduction (clinicaltrials.gov) - P2b | N=151 | Completed | Sponsor: Raziel Therapeutics Ltd. | Recruiting ➔ Completed

Trial completion

Efficacy and Safety of RZL-012 on Submental Fat Reduction (clinicaltrials.gov) - P2b; N=135; Recruiting; Sponsor: Raziel Therapeutics Ltd.; Trial completion date: Dec 2021 ➔ May 2022; Trial primary completion date: Dec 2021 ➔ Apr 2022

Clinical • Trial completion date • Trial primary completion date • MRI

Mode of Action of RZL-012, a New Fat-Reducing Molecule. (PubMed, Dermatol Surg) - "RZL-012 destroys adipocytes by directly disrupting cell membrane integrity. Replacement of dead fat tissue by fibrotic tissue enables healing and causes contraction of the injected area. These effects are translated into significant reduction in fat tissue volume."

Journal • Fibrosis • Genetic Disorders • Inflammation • Rare Diseases

Efficacy and Safety of RZL-012 on Submental Fat Reduction (clinicaltrials.gov) - P2b; N=135; Recruiting; Sponsor: Raziel Therapeutics Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • MRI

Efficacy and Safety of RZL-012 on Submental Fat Reduction (clinicaltrials.gov) - P2b; N=135; Not yet recruiting; Sponsor: Raziel Therapeutics Ltd.

Clinical • New P2b trial