metopimazine (NG101) / Neurogastrx - LARVOL DELTA

Key Results from Clinical Study of NG101 for Semaglutide-Induced Nausea and Vomiting (GlobeNewswire) - "In the study, a total of 90 participants aged 18-55 received a single subcutaneous dose of semaglutide (0.5 mg), along with five days of NG101 20 mg twice per day (BID) or placebo...Reduced the incidence of nausea by 40% (p=0.0203); Decreased the incidence of vomiting by 67% (p=0.0274) and the number of discrete vomiting episodes by 56% (p=0.0238); Reduced the duration of nausea and vomiting (p=0.0063); events lasting more than one day occurred in 22% vs. 51% of participants with NG101 vs. placebo; Decreased nausea severity by 70% (p=0.0138) as reported by the participant...,Participant-reported outcomes (PROs) in the study revealed a greater symptom burden of nausea and vomiting than clinical assessments suggested."

P2 data • Obesity

Proof-of-Concept, Placebo-Controlled Study of NG101 for Semaglutide-Induced Nausea and Vomiting (OBESITY WEEK 2025) - "Treatment with NG101 was well tolerated and resulted in a significant reduction of semaglutide-associated nausea and vomiting in generally healthy adults. These findings support the potential of NG101 to improve early tolerability of GLP-1 RAs. Addressing GI tolerability during the dose titration phase may be key to maximizing the real-world benefits of GLP-1 RA therapy."

Clinical • Cardiovascular • Genetic Disorders • Obesity • DRD2

Neurogastrx to Present Proof-of-Concept Clinical Data on Oral Candidate NG101 to Reduce Nausea & Vomiting Associated with GLP-1 Agonists at ObesityWeek (GlobeNewswire) - "Nausea and Vomiting Are the Most Frequent Reasons for Discontinuing GLP-1 Therapies, Significantly Impacting Adherence, Titration and Preventing Achievement of Proven Long-Term Benefits."

P1 data • Obesity

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Metopimazine Mesylate (NG101) in Participants with Gastroparesis. (PubMed, Am J Gastroenterol) - "While NG101 did not meet statistical significance in its primary endpoint for reducing nausea severity, it demonstrated a favorable safety profile and significant improvement in some secondary endpoints. Further study is needed to determine if NG101 is an effective treatment for patients with idiopathic gastroparesis."

Clinical • Journal • P2 data • Chemotherapy-Induced Nausea and Vomiting • Gastrointestinal Disorder • Pain • DRD2

A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants Receiving a GLP-1 Agonist (clinicaltrials.gov) - P2 | N=120 | Completed | Sponsor: Neurogastrx, Inc. | Active, not recruiting ➔ Completed

Adverse events • Trial completion • Genetic Disorders • Obesity

A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants Receiving a GLP-1 Agonist (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Neurogastrx, Inc. | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • Genetic Disorders • Obesity

A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants Receiving a GLP-1 Agonist (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Neurogastrx, Inc.

New P2 trial • Genetic Disorders • Obesity

A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis (clinicaltrials.gov) - P2 | N=162 | Completed | Sponsor: Neurogastrx, Inc. | Active, not recruiting ➔ Completed

Trial completion • Gastrointestinal Disorder

A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis (clinicaltrials.gov) - P2 | N=140 | Active, not recruiting | Sponsor: Neurogastrx, Inc. | Recruiting ➔ Active, not recruiting | N=280 ➔ 140

Enrollment change • Enrollment closed • Gastrointestinal Disorder

A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis (clinicaltrials.gov) - P2 | N=280 | Recruiting | Sponsor: Neurogastrx, Inc. | Trial completion date: Jun 2022 ➔ Apr 2023 | Trial primary completion date: Mar 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Gastrointestinal Disorder

Metopimazine is primarily metabolized by a liver amidase in humans. (PubMed, Pharmacol Res Perspect) - "Analysis of plasma samples from subjects dosed 60 mg of MPZ verified that these oxidative pathways are very minor and that CYP enzyme involvement was negligible compared to microsomal amidase/hydrolase in overall MPZ metabolism in humans. The metabolism by liver amidase, an enzyme family not well defined in small molecule drug metabolism, with minimal metabolism by CYPs, differentiates this drug from current D2 antagonists used or in development for the treatment of GP."

Journal • Gastrointestinal Disorder • CYP3A4 • DRD2

A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis (clinicaltrials.gov) - P2; N=280; Recruiting; Sponsor: Neurogastrx, Inc.; Trial completion date: Jun 2021 ➔ Jun 2022; Trial primary completion date: Mar 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • Gastrointestinal Disorder

A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis (clinicaltrials.gov) - P2; N=280; Recruiting; Sponsor: Neurogastrx, Inc.; Not yet recruiting ➔ Recruiting; Initiation date: Mar 2020 ➔ Aug 2020

Clinical • Enrollment open • Trial initiation date • Gastrointestinal Disorder

A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis (clinicaltrials.gov) - P2; N=280; Not yet recruiting; Sponsor: Neurogastrx, Inc.

Clinical • New P2 trial