Drugs / Toludesvenlafaxine
Toludesvenlafaxine
also known as
LY03005 · Toludesvenlafaxine hydrochloride · ansofaxine · LPM-570065 · LPM-570065 FREE BASE · LY-03005 HYDROCHLORIDE DIHYDRATE · ODVP2 · ODVP2 HYDROCHLORIDE DIHYDRATE · +2 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | depressive disorder | — | “除 了 中 国 以 外，LY03005的 临 床 试 验 也 在 美 国、日 本 同 步 开 展，并 已 分 别 进 入 新 药 上 市 申 请（NDA）和Ⅰ期 临 床 试 验 阶 段” luye.com ↗ |
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT03822065 | Jan → Feb 2019 | major depressive disorder | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03733574 | Jun → Jul 2018 | major depressive disorder | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03357796 | Nov → Dec 2017 | major depressive disorder | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02988024 | Dec 2016 | major depressive disorder | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03785652 | Oct 2015 | major depressive disorder | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02271412 | Oct 2014 → Mar 2015 | major depressive disorder | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02055300 | Feb → Aug 2014 | major depressive disorder | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT05970510 | Aug 2023 → Jul 2025 | generalized anxiety disorder | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04853407 | Dec 2018 → Dec 2020 | major depressive disorder | Luye Pharma Group Ltd. | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT07552246 | Apr 2026 → Mar 2027 expected | mixed anxiety and depressive disorder | Duke Kunshan University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06426485 | May 2024 → Feb 2027 expected | major depressive disorder | Luye Pharma Group Ltd. | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06026917 | Sep 2023 → Jan 2024 | major depressive disorder | Shanghai Mental Health Center | Unknown | No outcome recorded |
| Phase 4 | NCT05849272 | May 2023 → May 2024 | somatoform disorder | Shanghai Mental Health Center | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT07709416 | Sep 2026 → Sep 2028 expected | — | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07208357 | Oct 2025 → Jun 2027 expected | fibromyalgia | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| — | NCT06278038 | Feb → Nov 2024 | major depressive disorder | First Affiliated Hospital of Zhejiang University | Completed | No outcome recorded |
| — | NCT06270433 | Feb → Dec 2024 | atypical depressive disorder | Jiangsu Province Nanjing Brain Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2022-06-09 | Luye Pharma Group Ltd. | Results 绿叶制药1类新药LY03005 III期研究成果亮相2022 APA年会，疗效与安全性良好、全面改善抑郁症状 luye.com ↗
研 究 结 果 显 示：LY03005展 现 出 良 好 的 疗 效 及 安 全 性，可 全 面 改 善 抑 郁 症 状. |
| 2021-12-23 | Luye Pharma Group Ltd. | Results 绿叶制药抗抑郁新药盐酸安舒法辛缓释片 II 期临床数据发布 luye.com ↗
主 要 疗 效 终 点 显 示：LY03005各 剂 量 组6周 末 的17项 汉 密 尔 顿 抑 郁 量 表（HAM-D17）总 分 较 基 线 的 变 化 均 优 于 安 慰 剂 组，且 差 异 具 统 计 学 意 义（P<0.05）. |
| 2021-06-10 | Luye Pharma Group Ltd. | Regulatory 绿叶制药抗抑郁症1类新药盐酸安舒法辛缓释片上市申请获CDE受理 luye.com ↗
绿 叶 制 药 集 团 宣 布，其 自 主 研 发 的 中 国 化 学 药 品1类 新 药——盐 酸 安 舒 法 辛 缓 释 片（LY03005）的 上 市 申 请 已 正 式 获 得 中 国 国 家 药 品 监 督 管 理 局 药 品 审 评 中 心 受 理. |
| 2021-03-29 | Luye Pharma Group Ltd. | Results 绿叶制药1类新药盐酸安舒法辛缓释片Ⅲ期临床达预设终点 luye.com ↗
绿 叶 制 药 集 团 宣 布，其 自 主 研 发 的 新 化 合 物 及 中 国1类 化 学 新 药——盐 酸 安 舒 法 辛 缓 释 片（LY03005）在 中 国 的Ⅲ期 临 床 试 验 达 到 预 设 终 点. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-06-09 | Luye Pharma Group Ltd. | 绿叶制药1类新药LY03005 III期研究成果亮相2022 APA年会，疗效与安全性良好、全面改善抑郁症状 luye.com ↗ |
| 2021-12-23 | Luye Pharma Group Ltd. | 绿叶制药抗抑郁新药盐酸安舒法辛缓释片 II 期临床数据发布 luye.com ↗ |
| 2021-06-10 | Luye Pharma Group Ltd. | 绿叶制药抗抑郁症1类新药盐酸安舒法辛缓释片上市申请获CDE受理 luye.com ↗ |
| 2021-03-29 | Luye Pharma Group Ltd. | 绿叶制药1类新药盐酸安舒法辛缓释片Ⅲ期临床达预设终点 luye.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Toludesvenlafaxine | “Administer Toludesvenlafaxine (40-80 mg daily) or imported Sertraline (50-200 mg daily), supplemented with Lorazepam (0.4-0.8 mg) or Alprazolam (0.4-0.8 mg) as needed for sleep support.” NCT07552246 ↗ |
| Known as | ansofaxine | “A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to verify the efficacy and safety of ansofaxine (LY03005) for major depressive disorder.” PMID 37164957 ↗ May 2023 |
| Known as | LPM-570065 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4227736 ↗ |
| Known as | LPM-570065 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4227736 ↗ |
| Known as | LY-03005 HYDROCHLORIDE DIHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4227736 ↗ |
| Known as | LY03005 | “A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to verify the efficacy and safety of ansofaxine (LY03005) for major depressive disorder.” PMID 37164957 ↗ May 2023 |
| Known as | ODVP2 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4227736 ↗ |
| Known as | ODVP2 HYDROCHLORIDE DIHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4227736 ↗ |
| Known as | Roxylin | “OBJECTIVE: This study aimed to evaluate the efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets (Roxylin®) for somatic symptoms of major...” PMID 40661857 ↗ Jul 2025 |
| Known as | Toludesvenlafaxina | ChEMBL registry synonym — accepted as the source's own label CHEMBL4227736 ↗ |
| Known as | Toludesvenlafaxine hydrochloride | “Toludesvenlafaxine hydrochloride sustained-release tablets” NCT06270433 ↗1“Toludesvenlafaxine Hydrochloride Sustained-release Tablets” NCT06426485 ↗ |
| Action | Inhibit | “a potential triple reuptake inhibitor of serotonin, norepinephrine, and dopamine” PMID 37164957 ↗ May 2023 |
| Modality | Small molecule | — CHEMBL4227736 ↗ |
| Route | Oral | “single oral doses of LY03005” NCT02055300 ↗ |