46 completed, 15 unknown, 6 not yet recruiting, 5 recruiting. 56 Phase 1, 12 Phase 3, 9 Phase 2, 1 Phase 4.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Mass Balance Study of [14C] LPM3770164 in Healthy Participants [14C] LPM3770164 - Huntington Disease | Phase 1 | Not yet recruiting | Luye Pharma Group Ltd. | 8 | 2026-04-30 | 2026-04-08 |
| A Study of LY03015 in Healthy Chinese and Caucasian Adult Subjects LY03015 (LPM3770164 extended-release tablets) - Healthy Participants | Phase 1 | Completed | Luye Pharma Group Ltd. | 24 | 2026-04-15 | 2026-10-02 |
| A Phase 2 Study to Evaluate the Efficacy and Safety of LY03020 in Acutely Psychotic Participants With Schizophrenia LY03020, Placebo - Schizophrenia | Phase 2 | Not yet recruiting | Luye Pharma Group Ltd. | 160 | 2026-03-31 | 2026-02-09 |
| LPM6690176 in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation LPM6690176, Bevacizumab, FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan) - Metastatic Colorectal Cancer (mCRC) | Phase 1 / Phase 2 | Not yet recruiting | Luye Pharma Group Ltd. | 99 | 2026-03-31 | 2026-02-06 |
| To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Food Effects of LY03021 in Healthy Chinese Subjects LY03021, placebo - Major Depressive Disorder | Phase 1 | Enrolling by invitation | Luye Pharma Group Ltd. | 98 | 2025-10-28 | 2026-01-27 |
| A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020 LY03020, Placebo - Schizophrenia, Alzheimer's Disease Psychosis | Phase 1 | Recruiting | Luye Pharma Group Ltd. | 40 | 2025-08-20 | 2025-11-19 |
| A Food Effect Study of LY03020 in Healthy Subjects LY03020 - Schizophrenia, Alzheimer's Disease Psychosis | Phase 1 | Active not recruiting | Luye Pharma Group Ltd. | 16 | 2025-07-30 | 2025-12-18 |
| A Phase 1, MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY03017 LY03017, LY03017-Placebo - Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis, Hallucinations and Delusions Associated With Parkinson Disease Psychosis | Phase 1 | Not yet recruiting | Luye Pharma Group Ltd. | 40 | 2025-05-01 | 2025-05-20 |
| Effect of Food and Age on the Pharmacokinetics of LY03017 LY03017 - Alzheimer's Disease Psychosis, Parkinson Disease Psychosis | Phase 1 | Not yet recruiting | Luye Pharma Group Ltd. | 26 | 2025-02-01 | 2025-01-27 |
| Safety and Efficacy of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia LPM3770164 sustained release tablet 5 mg, LPM3770164 sustained release tablet 10 mg, LPM3770164 sustained release tablet 20 mg - Tardive Dyskinesia (TD) | Phase 1 / Phase 2 | Recruiting | Luye Pharma Group Ltd. | 120 | 2025-01-14 | 2025-01-22 |
| Identify Effective Doses of LY01021 in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART) LY01021 - Assisted Reproduction | Phase 2 | Active not recruiting | Luye Pharma Group Ltd. | 90 | 2024-10-09 | 2025-11-19 |
| Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC Lurbinectedin, Irinotecan, Topotecan - Relapsed Small Cell Lung Cancer | Phase 3 | Recruiting | Luye Pharma Group Ltd. | 180 | 2024-09-14 | 2024-12-12 |
| A Study Assessing the Safety and Tolerability of LY03020 in Chinese Healthy Subjects LY03020, Placebo - Schizophrenia, Alzheimer's Disease Psychosis | Phase 1 | Completed | Luye Pharma Group Ltd. | 66 | 2024-08-19 | 2025-05-29 |
| Effect of Food on the Pharmacokinetics of LPM3770164 Sustained-release Tablets LPM3770164 sustained release tablet - Huntington Disease, Tardive Dyskinesia | Phase 1 | Completed | Luye Pharma Group Ltd. | 16 | 2024-07-31 | 2024-12-12 |
| To Evaluate the Long-term Efficacy and Safety of Toludevenlafaxine Hydrochloride Sustained-release Tablets Toludesvenlafaxine Hydrochloride Sustained-release Tablets, placebo - Major Depressive Disorder | Phase 4 | Not yet recruiting | Luye Pharma Group Ltd. | 736 | 2024-05-30 | 2024-05-23 |
| A Phase 1, SAD Study to Evaluate the Safety and Tolerability of LY03017 LY03017, LY03017-Placebo - Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis, Hallucinations and Delusions Associated With Parkinson Disease Psychosis | Phase 1 | Unknown | Luye Pharma Group Ltd. | 60 | 2024-05-10 | 2024-04-29 |
| First-in-Human Study of LPM6690176 in Patients With Advanced Solid Tumors. LPM6690176 - Advanced Solid Tumor | Phase 1 | Recruiting | Luye Pharma Group Ltd. | 102 | 2024-03-12 | 2024-03-15 |
| Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer Irinotecan hydrochloride liposome Injection, Topotecan - Relapsed Small Cell Lung Cancer | Phase 3 | Recruiting | Luye Pharma Group Ltd. | 686 | 2024-03-03 | 2024-03-15 |
| Phase II Clinical Trial to Evaluate the Efficacy and Safety of LPM3480392 Injection for Moderate to Severe Pain After Orthopedic Surgery Placebo, morphine hydrochloride injection, LPM3480392 Injection - Pain, Postoperative | Phase 2 | Unknown | Luye Pharma Group Ltd. | 150 | 2024-01-26 | 2024-06-21 |
| Safety, Tolerability and Pharmacokinetic of Multiple-ascending Doses of LPM3770164 in Healthy Subjects LPM3770164 sustained release tablet, LPM3770164 sustained release tablet simulant - Tardive Dyskinesia, Huntington Disease | Phase 1 | Completed | Luye Pharma Group Ltd. | 40 | 2023-12-19 | 2024-12-12 |
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Parkinson Disease (13) · Depressive Disorder, Major (10) · Schizophrenia (10) · Psychotic Disorders (6) · Mental Disorders (5) · Mood Disorders (5) · Huntington Disease (4) · Prostatic Neoplasms (4) · Tardive Dyskinesia (4) · Depressive Disorder (3) · Small Cell Lung Carcinoma (3) · Hallucinations (2) · Osteoporosis, Postmenopausal (2) · Pain, Postoperative (2) · Breast Neoplasms (1)
rotigotine (8) · Injections (7) · Desvenlafaxine Succinate (5) · Goserelin (5) · Denosumab (4) · Paliperidone Palmitate (4) · Irinotecan (3) · Bevacizumab (2) · PM 01183 (2) · Topotecan (2) · Drug Implants (1) · Fluorouracil (1) · Injections, Intramuscular (1) · Leucovorin (1) · Lovastatin (1)
China (45) · United States (22) · Germany (2) · Australia (1) · Bulgaria (1) · Czechia (1) · Japan (1) · Poland (1)
Simon Li (3) · Amy Sun, MD, PhD, MBA (2) · Kevin Booth, MD, DVM (2) · Rui Li, MD (2) · Ahad Sabet, MD (1) · Amy Sun, MD PhD (1) · Angela Molga (1) · David Krefetz, MD (1) · Dingwei Ye (1) · Gang Wang (1) · Guoping Yang, doctor (1) · Hongyan Zhang (1) · Huafang Li, Doctor (1) · Huanhuan Jiang (1)
PMID 38244179, PMID 42752599, PMID 34031756, PMID 34184418, PMID 34878625, PMID 36045484, PMID 37010251, PMID 37164957, PMID 38351146, PMID 41035912