GS1-144 / GeneScience - LARVOL DELTA

GenSci074-107: To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets . (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Feb 2027 ➔ Jul 2026 | Trial primary completion date: Oct 2026 ➔ Jul 2026

Trial completion • Trial completion date • Trial primary completion date

GenSci074-107: To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets . (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

GenSci074-104: A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of Oral [14C]GS1-144 in Healthy Postmenopausal Female Participants (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of Oral [14C]GS1-144 in Healthy Postmenopausal Female Participants (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P1 trial

To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets . (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P1 trial

Efficacy and safety of GS1-144, a novel neurokinin 3 receptor antagonist, for moderate-to-severe vasomotor symptoms associated with menopause in Chinese women: a randomized, double-blind, placebo-controlled phase 2 trial. (PubMed, Menopause) - "GS1-144 is well tolerated and significantly reduces VMS frequency and severity in postmenopausal Chinese women."

Clinical • Journal • P2 data

GS1-144 in Participants With Hepatic Impairment and Healthy Female (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P1 trial • Hepatology

Safety, Pharmacokinetics, and Pharmacodynamics of GS1-144, a Neurokinin-3 Receptor Antagonist: A Randomized Phase 1 Single and Multiple Ascending Dose and Food Effect Study. (PubMed, Eur J Pharm Sci) - P1 | "GS1-144 could be administered with or without meals with no clinically significant impact on PK exposure. These results support further clinical development of GS1-144 for the treatment of VMS."

First-in-human • Journal • P1 data • PK/PD data

Clinical Study to Evaluate the Efficacy and Safety of GS1-144 Tablets in the Treatment of Moderate to Severe Vasomotor Symptoms in Chinese Postmenopausal Women. (clinicaltrials.gov) - P2 | N=129 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion

Advances in Pharmacotherapy for Menopausal Vasomotor Symptoms. (PubMed, Drugs) - "Fezolinetant (NK3 receptor antagonist) and the newly approved elinzanetant (NK1 and NK3 receptor antagonist) are non-hormonal treatment options approved for the treatment of VMS associated with menopause. A number of investigational agents are currently in phase 2 trials for potential future use for VMS; these include Q-122, PhytoSERM, NOE-115, GS1-144, and HS-10384. In this review, we highlight the recent advancements in our understanding of the pathophysiology of VMS and consider the current, new, and investigational treatment options for the treatment of VMS."

Journal • Review • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Coronary Artery Disease • Heart Failure • Sleep Disorder

A Bioavailability Study of GS1-144 Tablets in Healthy Postmenopausal Women (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion

A Bioavailability Study of GS1-144 Tablets in Healthy Postmenopausal Women (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P1 trial

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Dose Escalation of GS1-144 Tablets and the Effects of Food on the Pharmacokinetics of GS1-144 in a Chinese Population (clinicaltrials.gov) - P1 | N=110 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Aug 2024 ➔ Nov 2024

Trial completion • Trial completion date

First-in-human Study of GS1-144, a Neurokinin-3 Receptor Antagonist: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic in Healthy Participants (ESPE-ESE 2025) - "GS1-144 demonstrated favorable safety and tolerability with linear PK profile and dose-dependent LH suppression."

Clinical • Late-breaking abstract • P1 data • PK/PD data

A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of GS1-144 Tablet in the Treatment of Moderate to Severe Vasomotor Symptoms in Chinese Postmenopausal Women (Grace-2) (ChiCTR) - P=N/A | N=90 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital; Peking Union Medical College Hospital

New trial

T-Cell Responses Induced by GS-1966+GS-1144 Vaccines in Virally Suppressed People With HIV (CROI 2025) - "Significant differences in Gag-specific T-cell polyfunctionality were noted for both CD4+ and CD8+ T-cell responses in cohort 3, suggesting that GS-1966+GS-1144 is able to induce highly functional T-cell responses to a key vaccine region. These results expand our understanding of T-cell response quality induced by GS-1966+GS-1144, a novel vaccine regimen for HIV cure."

Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8 • IFNG

A Study to Assess Safety and Tolerability of GS1-144 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=86 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: May 2025 ➔ Dec 2024

Trial completion • Trial completion date