Ruoxinlin (toludesvenlafaxine extended release) / Luye Group - LARVOL DELTA

Novel and promising treatments for anxiety disorders (WFSBP 2026) - "Results / Several compounds are in development, including drugs targeting the serotonin system (toludesvenlafaxine, gepirone, FKW00GA), the trace amine-associated receptor 1 (TAAR1), , the GABA binding site (ENX-102, darigabat, and buagafuran), the nicotinic receptor (soclenitant and VQW-765), the endocannabinoid system (cannabidiol and SYT-510), pherins (fasedienol) and psychedelics (MM120, PSX-001, MSP-1014). The translation of these compounds into clinically approved treatments for anxiety disorders may take several years, potentially delaying the emergence of significant therapeutic breakthroughs."

CNS Disorders • Mood Disorders • Psychiatry

Toludesvenlafaxine for Non-specific Low Back Pain (clinicaltrials.gov) - P=N/A | N=132 | Recruiting | Sponsor: Beijing Tiantan Hospital | Not yet recruiting ➔ Recruiting

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

Exploratory Study of Pharmacogenomic Biomarkers for Toludesvenlafaxine (ChiCTR) - P=N/A | N=200 | Not yet recruiting | Sponsor: Affiliated Kangning Hospital of Ningbo University; Affiliated Kangning Hospital of Ningbo University

Biomarker • New trial • CNS Disorders • Depression • Mood Disorders • Psychiatry

Toludesvenlafaxine for Non-specific Low Back Pain (clinicaltrials.gov) - P=N/A | N=132 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital

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

A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder. (clinicaltrials.gov) - P3 | N=555 | Completed | Sponsor: Luye Pharma Group Ltd. | Recruiting ➔ Completed | Trial completion date: Apr 2026 ➔ Jul 2025 | Trial primary completion date: Apr 2026 ➔ Jul 2025

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

A study on the long-term functional recovery of toludesvenlafaxine hydrochloride sustained-release tablets in patients with depression aged 18 to 45 years old in the working population. (ChiCTR) - P4 | N=90 | Recruiting | Sponsor: Second Xiangya Hospital of CSU; Second Xiangya Hospital of CSU

New P4 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in depression with ineffective or partially effective initial antidepressant treatment: a single-arm, multicenter clinical study. (PubMed, Front Psychiatry) - "This study confirmed that toludesvenlafaxine not only has significant clinical efficacy (including early onset, high remission, and response) for patients with depression who did not respond to the first antidepressant treatment, but also has good safety and can improve sexual dysfunction that affects compliance. This result highlights the significant position of toludesvenlafaxine in addressing the key clinical challenge of first treatment failure, providing a highly valuable new option for the subsequent treatment of such patients."

Clinical • Journal • CNS Disorders • Constipation • Depression • Gastroenterology • Gastrointestinal Disorder • Mental Retardation • Mood Disorders • Psychiatry • Sexual Disorders

Clinical observational study on rapid titration of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of patients with major depression disorder (ChiCTR) - P4 | N=200 | Not yet recruiting | Sponsor: Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine; Shandong Luye Pharmaceutical Co., Ltd.

New P4 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Structural basis for pharmacotherapeutic action of triple reuptake inhibitors. (PubMed, Nat Commun) - "Tesofensine and dasotraline stabilize DAT in an outward-facing conformation, while centanafadine, ansofaxine, and nefazodone capture the inward-facing conformation. Notably, ansofaxine binds at a location which is much closer to the intracellular membrane surface. Through extensive structural analysis, we establish a comprehensive blueprint for the association of these TRIs, which is crucial for future drug development aimed at achieving potent antidepressant with fewer side effect."

Journal • CNS Disorders • Depression • Psychiatry

Efficacy and safety of Toludesvenlafaxine extended-release tablets in the treatment of treatment-resistant depression. (PubMed, BMC Psychiatry) - P4 | "These findings suggest that Toludesvenlafaxine may be associated with improvements in both depressive and anxiety symptoms, as well as quality of life, in patients with TRD. This study provides evidence supporting the use of Toludesvenlafaxine as an effective treatment option for TRD and emphasizes the need for further research to confirm its long-term efficacy and safety."

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

The Efficacy and Safety of Pregabalin Combined With Toludesvenlafaxine in Patients With Fibromyalgia (clinicaltrials.gov) - P=N/A | N=384 | Recruiting | Sponsor: Beijing Tiantan Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Evaluate the sustained-release tablets of Toludine Hydrochloride and Rafaxine Hydrochloride (Ruoxetine) ®) A multicenter, randomized, open label, parallel, positive drug controlled, fixed dose clinical study on the efficacy and safety of treating adolescent depression patients (ChiCTR) - P4 | N=200 | Recruiting | Sponsor: Beijing Anding Hospital, Capital Medical University; Beijing Anding Hospital, Capital Medical University

New P4 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

The Efficacy and Safety of Pregabalin Combined With Toludesvenlafaxine in Patients With Fibromyalgia (clinicaltrials.gov) - P=N/A | N=384 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital

Monotherapy • New trial • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-Release Tablets on Somatic Symptoms of Major Depressive Disorder: A Prospective, Single-Arm, Multicenter Clinical Study (WFSBP 2025) - "Toludesvenlafaxine hydrochloride significantly improved somatic symptoms in patients with MDD and somatic symptoms, with a favorable safety profile, supporting its use as an effective treatment option."

Clinical • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Ansofaxine Hydrochloride inhibits hepatocellular carcinoma growth and enhances targeted therapy through the EGFR/MAPK pathway. (PubMed, Front Oncol) - "In vivo experiments showed that Ansofaxine Hydrochloride has a synergistic effect of enhancingLenvatinib anti-HCC, enhancing peripheral blood DA level, promoting M1 macrophage infiltration, and enhancing immune anti-tumor effects, and is associated with the reduction of EGFR/MAPK pathway-related genes. Our study suggests that Ansofaxine Hydrochloride has anti-HCC and immunomodulatory effects, with the EGFR/MAPK pathway as a potential key mechanism of action."

Journal • CNS Disorders • Depression • Hepatocellular Cancer • Oncology • Psychiatry • Solid Tumor

Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-Release Tablets on Somatic Symptoms of Major Depressive Disorder: A Prospective, Single-Arm, Multicenter Clinical Study. (PubMed, Neuropsychiatr Dis Treat) - P4 | "Toludesvenlafaxine hydrochloride significantly improved somatic symptoms in patients with MDD and somatic symptoms, with a favorable safety profile, supporting its use as an effective treatment option. NCT05849272."

Clinical • Journal • CNS Disorders • Depression • Fatigue • Major Depressive Disorder • Mood Disorders • Pain • Psychiatry

A Study on the Efficacy and Safety of Toludesvenlafaxine Hydrochloride in the Treatment of Major Depressive Disorder in Adolescents Aged 13-17 Years (ChiCTR) - P4 | N=120 | Not yet recruiting | Sponsor: Shandong Provincial Hospital Affiliated to Shandong First Medical University; Shandong Provincial Hospital Affiliated to Shandong First Medical Univer

New P4 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Efficacy and Safety of Toluedesvenlafaxine Hydrochloride Extended-release Tablets in Somatic Symptoms of Depression (clinicaltrials.gov) - P4 | N=60 | Completed | Sponsor: Shanghai Mental Health Center | Not yet recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Mood Disorders • Psychiatry

Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-Release Tablets in Depression With Anhedonia: A Single-Arm, Multicenter Clinical Study. (PubMed, Depress Anxiety) - P4 | "These findings indicate that toludesvenlafaxine hydrochloride sustained-release tablets are safe, well-tolerated, and effective in alleviating anhedonia symptoms in patients with depression. Trial Registration: http://www.chictr.org.cn (No.: ChiCTR2300070331)."

Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • BDNF • IGF1

CLASS 1 INNOVATIVE ANTIDEPRESSANT RUOXINLIN APPROVED FOR MARKETING IN MACAO (HKEXnews) - "The board of directors (the 'Board') of Luye Pharma Group...announces that Ruoxinlin (Toludesvenlafaxine Hydrochloride Extended-Release Tablets), the Group’s innovative drug for treating Major Depressive Disorder ('MDD'), has been approved for marketing in Macao by the Pharmaceutical Administration Bureau of the Macao SAR Government....The results of the Phase 3 clinical study of Ruoxinlin demonstrated that it is able to treat MDD in a comprehensive and stable manner....At the end of 2024, following successful negotiations, Ruoxinlin was included in the China’s National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2024 Version) for the first time."

Approval • Reimbursement • Major Depressive Disorder

Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder (clinicaltrials.gov) - P=N/A | N=84 | Completed | Sponsor: First Affiliated Hospital of Zhejiang University | Recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Uncovering the Elusive Structures and Mechanisms of Prevalent Antidepressants. (PubMed, Adv Ther (Weinh)) - "In this study, we apply microcrystal electron diffraction (MicroED) to reveal the atomic 3D structures for the first time of five of the most prevalent antidepressants (reboxetine, pipofezine, ansofaxine, phenelzine, bifemelane) directly from the commercially available powder of the active ingredients. Their modes of binding are investigated by molecular docking, revealing the essential contacts and conformational changes into the biologically active state. This study underscores the combined use of MicroED and molecular docking to uncover elusive drug structures and mechanisms to aid in further drug development pipelines."

Journal • CNS Disorders • Depression • Major Depressive Disorder • Psychiatry

Ansofaxine suppressed NSCLC progression by increasing sensitization to combination immunotherapy. (PubMed, Int Immunopharmacol) - "The findings suggest that Ansofaxine may represent a promising therapeutic approach for NSCLC patients with comorbid depression, potentially enhancing both mental well-being and cancer-related outcomes."

IO biomarker • Journal • CNS Disorders • Depression • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Psychiatry • Solid Tumor • CD8 • PD-L1 • PTPN1

Luye Pharma’s Antidepressant Drug LY03005 Completes Primary Endpoint Observation for a Phase III Clinical Trial in China (Luye Press Release) - "Luye Pharma Group announced today that the enrollment and follow-up of patients in a phase III clinical trial, an efficacy and safety comparative study of LY03005 with placebo, has been completed...The clinical trial study involved the enrolment of 558 patients, all of whom have completed the study following observations in changes of the ten-item Montgomery-Åsberg depression rating scales (MADRS) total score from baseline as the primary endpoint under blind state....'We are expediting the development and launch of this drug as quickly as we can.'"

Trial primary completion date • CNS Disorders • Depression

Toludesvenlafaxine- An Innovative Agent or Just Another „me, too” drug? (ISBD 2024) - "The available data are derived from industry-sponsored research, therefore independent data are needed to validate the preliminary efficacy and good tolerability of toludesvenlafaxine in patients with MDD."

CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry