101 completed, 6 terminated, 4 withdrawn, 2 recruiting. 42 Phase 3, 25 Phase 2, 24 Phase 4, 13 Phase 1, 2 Not applicable.
Follow BOTOX®: new trials by email Literature Review of BOTOX® trials Research Report on BOTOX®
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 |
|---|---|---|---|---|---|---|
| Botulinum Toxin Type A Injection Sites for Oral Commissure Ptosis OnabotulinumtoxinA (Upper Depressor Anguli Oris Injection), OnabotulinumtoxinA (Lower Depressor Anguli Oris Injection) - Facial Aging, Melomental Folds | Phase 4 | Not yet recruiting | Peking University | 266 | 2026-07-01 | 2026-07-07 |
| Preoperative BOTOX® Injection for Large Ventral Hernia Repair OnabotulinumtoxinA Injection, Saline (placebo) Injection, OnabotulinumtoxinA - Hernia Abdominal Wall, Botox Injection | Phase 4 | Recruiting | The Cleveland Clinic | 188 | 2025-11-03 | 2026-10-26 |
| A Clinical Study on Recombinant Botulinum Toxin Type A (YY001) for Injection in The Treatment of Upper Limb Spasticity in Adults Recombinant Botulinum Toxin Type A for injection (YY001), BOTOX®, Placebo - Upper Limb Spasticity | Phase 2 / Phase 3 | Recruiting | Chongqing Claruvis Pharmaceutical Co., Ltd. | 254 | 2024-09-14 | 2026-01-22 |
| A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection (CU-20101) CU-20101 treatment for Moderate to Severe Glabellar Striae, BOTOX® - Glabellar Frown Lines | Phase 3 | Completed | Cutia Therapeutics（Wuxi）Co.,Ltd | 554 | 2024-06-24 | 2026-06-15 |
| A Phase I/II, Randomized, Double-blind, Placebo, and Active Controlled Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, and Preliminary Efficacy of JHM03 in Subjects With Moderate to Severe Glabellar Lines JHM03, BOTOX®, Placebo - Moderate to Severe Glabellar Lines | Phase 1 / Phase 2 | Completed | JHM BioPharma (Tonghua) Co. , Ltd. | 190 | 2024-01-19 | 2025-04-02 |
| Evaluate the Safety and Efficacy of HG102 as Compared to Botox® in Subject With Moderate to Severe Glabellar Lines Botulinum Toxin Type A Injection [HG102], Botulinum Toxin Type A Injection [Botox] - Glabellar Lines | Phase 3 | Unknown | Hugel | 272 | 2024-01-04 | 2024-01-16 |
| Evaluate the Safety and Explore the Efficacy of DWP712 With Moderate to Severe Glabellar Lines DWP712, BOTOX® - Glabellar Lines | Phase 1 | Completed | Daewoong Pharmaceutical Co. LTD. | 20 | 2023-11-28 | 2024-04-04 |
| Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines in Phase 3 Trial CKDB-501A, Botox® - Glabellar Lines | Phase 3 | Completed | CKD Bio Corporation | 300 | 2023-04-13 | 2023-12-12 |
| The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines PROTOXIN, Botox® - Glabellar Frown Lines | Phase 3 | Completed | Protox Inc. | 269 | 2023-03-06 | 2023-11-18 |
| Safety and Efficacy of CKDB-501A in Subjects With Post-stroke Upper Limb Spasticity CKDB-501A, Botox® - Post-stroke Upper Limb Spasticity | Phase 1 | Completed | CKD Bio Corporation | 24 | 2022-06-02 | 2023-03-28 |
| Safety and Efficacy of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines CKDB-501A, Botox® - Glabellar Lines | Phase 1 | Completed | CKD Bio Corporation | 30 | 2022-02-15 | 2022-11-17 |
| Double-blind Comparative Randomized Multicenter Miotox (Botulinum toxin type A is a hemagglutinin complex), BOTOX® - Cerebral Palsy (CP) | Phase 3 | Completed | Innopharm LLC | 80 | 2021-10-15 | 2025-02-21 |
| A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity. AboBoNT-A, OnaBoNT-A - Upper Limb Spasticity | Phase 4 | Completed | Ipsen | 464 | 2021-06-23 | 2026-07-09 |
| To Compare the Safety and Efficacy of "HG-102" With Botox® in the Improvement of Moderate to Severe Glabellar Lines. Botulinum Toxin Type A Injection [Botox], Botulinum toxin type A injection [HG-102] - Glabellar Lines | Phase 1 | Completed | Hugel | 38 | 2021-06-11 | 2022-05-24 |
| Treatment of Moderate to Severe Glabellar Lines (BMI2006) BMI2006, BOTOX® - Glabellar Lines | Phase 3 | Completed | BMI Korea | 278 | 2021-02-09 | 2022-09-08 |
| The Safety and Efficacy Study of PROTOXIN in Subjects With Moderate to Severe Glabellar Lines PROTOXIN, Botox® - Glabellar Frown Lines | Phase 1 / Phase 2 | Completed | Protox Inc. | 60 | 2020-12-10 | 2021-08-10 |
| DWP450 for Treating Moderate to Severe Glabellar Lines DWP450, Botox® - Moderate to Severe Glabellar Lines | Phase 3 | Completed | Daewoong Pharmaceutical Co. LTD. | 473 | 2020-08-12 | 2024-04-09 |
| Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia Botulinum toxin type A injection, Botulinum Toxin Type A Injection [Botox] - Cervical Dystonia | Phase 1 | Completed | Hugel | 38 | 2020-05-26 | 2022-04-22 |
| Evaluate the Safety and Efficacy of Botulax® Versus Botox® in Patient With Overactive Bladder Botulinum toxin type A injection, Botulinum Toxin Type A Injection [Botox] - Overactive Bladder | Phase 1 | Completed | Hugel | 38 | 2020-05-12 | 2022-04-15 |
| BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence Botulinum Toxin Type A, Placebo - Masseter Muscle Prominence | Phase 3 | Completed | AbbVie | 377 | 2019-08-29 | 2025-05-06 |
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Urinary Bladder, Overactive (20) · Muscle Spasticity (15) · Urinary Incontinence (14) · Migraine Disorders (10) · Stroke (7) · Cerebral Palsy (5) · Torticollis (5) · Hyperhidrosis (3) · Prostatic Hyperplasia (3) · Headache (2) · Osteoarthritis (2) · Paresis (2) · Urinary Bladder, Neurogenic (2) · Blepharospasm (1) · Depression (1)
Allergan (78) · Hugel (4) · CKD Bio Corporation (3) · Medy-Tox (3) · Daewoong Pharmaceutical Co. LTD. (2) · Hexsel Dermatology Clinic (2) · Protox Inc. (2) · AbbVie (1) · Assistance Publique - Hôpitaux de Paris (1) · BMI Korea (1) · Chongqing Claruvis Pharmaceutical Co., Ltd. (1) · Columbia University (1) · Cutia Therapeutics（Wuxi）Co.,Ltd (1) · Cynosure, Inc. (1) · EuBiologics Co.,Ltd (1)
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