18 completed, 3 terminated, 1 recruiting. 8 Phase 3, 7 Phase 1, 6 Phase 2, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 8 | Completed 8 |
| Phase 1 | 7 | Completed 6, Recruiting 1 |
| Phase 2 | 6 | Completed 4, Terminated 2 |
| Not applicable | 1 | Terminated 1 |
Follow ATX-101: new trials by email Literature Review of ATX-101 trials Research Report on ATX-101
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 |
|---|---|---|---|---|---|---|
| Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma Ronkyla Plus, Placebo, Kybella - Lipoma, Submental Fullness | Phase 1 | Recruiting | Glonova Pharma Co., Ltd | 56 | 2025-11-14 | 2026-10-02 |
| Study Assessing Pain Relief After Replacement of the Knee ATX-101, bupivacaine hydrochloride without epinephrine - Acute Postoperative Pain | Phase 2 | Terminated | Allay Therapeutics, Inc. | 112 | 2022-06-07 | 2025-08-14 |
| ATX-101 in Advanced Dedifferentiated Liposarcoma and Leiomyosarcoma ATX-101 - Leiomyosarcoma, Liposarcoma | Phase 2 | Terminated | Benjamin Izar | 4 | 2022-01-11 | 2023-12-06 |
| Cryolipolysis Versus ATX-101 (Deoxycholic Acid) for Upper Back Fat CoolCurve, ATX-101 - Upper Back Fat | Not applicable | Terminated | Northwestern University | 8 | 2017-11-27 | 2025-05-06 |
| Condition of Submental Fullness and Treatment Outcomes Registry Deoxycholic acid, Surgical Procedures, Laser Liposuction - Submental Fullness | Completed | Kythera Biopharmaceuticals | 1029 | 2015-05-11 | 2018-10-05 | |
| Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age ATX-101, Placebo - Moderate to Severe Convexity of Submental Fat, Safety | Phase 3 | Completed | Kythera Biopharmaceuticals | 55 | 2014-04-01 | 2020-02-17 |
| Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101 ATX-101, Placebo - Submental Fat, Healthy | Phase 3 | Completed | Kythera Biopharmaceuticals | 224 | 2013-12-01 | 2020-02-17 |
| Patient Experience Study of Deoxycholic Acid Injection Deoxycholic Acid Injection, Placebo, Cold Compress - Moderate or Severe Submental Fullness | Phase 3 | Completed | Kythera Biopharmaceuticals | 84 | 2013-12-01 | 2015-07-28 |
| Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area Deoxycholic acid injection, Placebo - Moderate or Severe Submental Fullness | Phase 3 | Completed | Kythera Biopharmaceuticals | 516 | 2012-03-01 | 2015-06-15 |
| Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area Deoxycholic acid injection, Placebo - Moderate or Severe Submental Fullness | Phase 3 | Completed | Kythera Biopharmaceuticals | 506 | 2012-02-01 | 2015-06-15 |
| To Evaluate the Safety, Tolerability and to Compare the Pharmacokinetic Profile of ATX-101 ATX-101 - Healthy | Phase 1 | Completed | Kythera Biopharmaceuticals | 5 | 2011-10-01 | 2016-05-06 |
| Open-Label Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area Deoxycholic acid injection - Moderate or Severe Submental Fullness | Phase 3 | Completed | Kythera Biopharmaceuticals | 165 | 2011-08-01 | 2016-01-14 |
| Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat Deoxycholic acid injection, Placebo - Moderate or Severe Submental Fullness | Phase 3 | Completed | Kythera Biopharmaceuticals | 360 | 2011-01-01 | 2015-06-12 |
| Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat Deoxycholic acid injection, Placebo - Moderate or Severe Submental Fullness | Phase 3 | Completed | Kythera Biopharmaceuticals | 363 | 2010-12-01 | 2015-07-14 |
| Lipid and Adipokine Profiles Following Subcutaneous Injection of ATX-101 Into Abdominal Fat Tissue ATX-101 - Healthy | Phase 1 | Completed | Kythera Biopharmaceuticals | 10 | 2010-12-01 | 2011-03-22 |
| Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study Deoxycholic acid injection, Placebo - Moderate or Severe Submental Fullness | Phase 2 | Completed | Kythera Biopharmaceuticals | 129 | 2009-12-01 | 2015-06-15 |
| ATX-101 Abdominoplasty ATX-101 - Characteristics of Subcutaneous Fat | Phase 1 | Completed | Kythera Biopharmaceuticals | 14 | 2008-11-01 | 2010-01-27 |
| Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat Deoxycholic Acid Injection, Placebo - Moderate or Severe Submental Fullness | Phase 2 | Completed | Kythera Biopharmaceuticals | 73 | 2008-04-01 | 2015-07-14 |
| Dose-Escalation Safety and Pharmacokinetic Study of ATX-101 ATX-101 - Healthy | Phase 1 | Completed | Kythera Biopharmaceuticals | 24 | 2008-01-01 | 2014-05-30 |
| Phase 2 Study for the Treatment of Superficial Lipomas Deoxycholic Acid Injection, Placebo - Lipoma | Phase 2 | Completed | Kythera Biopharmaceuticals | 62 | 2007-11-01 | 2016-01-14 |
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Lymphoma, Follicular (9) · Lipoma (3) · Leiomyosarcoma (1) · Liposarcoma (1) · Pain, Postoperative (1)
Kythera Biopharmaceuticals (18) · Allay Therapeutics, Inc. (1) · Benjamin Izar (1) · Glonova Pharma Co., Ltd (1) · Northwestern University (1)
United States (16) · Canada (7) · United Kingdom (5) · Australia (3) · Belgium (2) · France (2) · Germany (2) · Spain (2) · Italy (1) · Taiwan (1)
Frederick Beddingfield, MD, PhD (5) · Frederick Beddingfield, III, MD, PhD (3) · Patricia Walker, MD, PhD (2) · Benjamin Izar, MD (1) · Dennis Swearingin, M.D. (1) · Frederick Beddingfield, III, M.D., Ph.D. (1) · Frederick Beddingfield, III, M.D., PhD (1) · Frederick Beddingfield, M.D. (1) · Frederick Beddingfield, MD. PhD (1) · Murad Alam, MD (1) · Patricia S. Walker, M.D., Ph.D. (1) · Patricia Walker, M.D., Ph.D. (1) · Rina Patel, MS, CCRA (1) · Stacy R. Smith, M.D. (1) · Yu-Hsiu Yen, MD (1)
PMID 24984785, PMID 27787269, PMID 30681793, PMID 31524342, PMID 33617632, PMID 34115682, PMID 39034053