Drugs / Deoxycholic Acid
Deoxycholic Acid
also known as
DWJ211 · ATX-101 · ATX-101 deoxycholic acid injection · deoxycholate · Kybella · Sodium Deoxycholate for Injection
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | KYBELLA | — | 2015-04-29 | fda.gov ↗ |
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04054011 | Jul 2019 → May 2020 | obesity disorder | University of California, San Diego | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT06756490 | Dec 2024 → Dec 2026 expected | — | Sichuan Huiyu Pharmaceutical Co., Ltd | Recruiting | No outcome recorded |
| Phase 1 | NCT04159961 | Dec 2019 → Apr 2020 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT00422188 | Jan → Nov 2007 | lipoma | Kythera Biopharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00618722 | Aug 2007 → Oct 2008 | — | Kythera Biopharmaceuticals | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03224117 | Oct 2017 → Jun 2018 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 2 | NCT00618618 | Apr → Dec 2008 | — | Kythera Biopharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00608842 | Nov 2007 → Aug 2008 | lipoma | Kythera Biopharmaceuticals | Completed | No outcome recorded |
| Phase 38 trials · 4 met primary · 1 missed | ||||||
| Phase 3 | NCT03946592 | May 2019 → Jul 2020 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 3 | NCT02035267 | Jan 2014 → Jun 2015 | — | Kythera Biopharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02007434 | Dec 2013 → Jun 2014 | — | Kythera Biopharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT01546142 | Mar 2012 → May 2013 | — | Kythera Biopharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01542034 | Feb 2012 → May 2013 | — | Kythera Biopharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01426373 | Aug 2011 → Jun 2013 | — | Kythera Biopharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01294644 | Jan 2011 → Feb 2012 | — | Kythera Biopharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01305577 | Dec 2010 → Jan 2012 | — | Kythera Biopharmaceuticals | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT04089722 | Jul 2019 → Jun 2020 | — | Juva Skin & Laser Center | Completed | No outcome recorded |
| Phase not applicable1 trial · 1 met primary | ||||||
| — | NCT00757081 | Jun 2008 → Dec 2009 | — | BodyAesthetic Research Center | Completed | Met primary |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT07237425 Comparator | Nov 2025 → May 2028 expected | lipoma | Glonova Pharma Co., Ltd | Recruiting | No outcome recorded |
| Phase 1 | NCT06132165 Comparator | Mar 2024 → Jul 2025 | neurofibromatosis type 1 | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02163902 Background | Dec 2013 → Jan 2016 | — | Kythera Biopharmaceuticals | Completed | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | deoxycholic acid | “A Prospective, Blinded (Evaluators and Subjects Blinded), Randomized Controlled Phase I Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of...” NCT06756490 ↗16“BACKGROUND: ATX-101 (deoxycholic acid) significantly reduced submental fat (SMF) severity in two 24-week Phase 3 studies (REFINE-1 and REFINE-2).” PMID 33617632 ↗ Oct 2021 “10 mg/mL deoxycholic acid injection.” NCT07237425 ↗ |
| Known as | ATX-101 | “BACKGROUND: ATX-101 (deoxycholic acid) significantly reduced submental fat (SMF) severity in two 24-week Phase 3 studies (REFINE-1 and REFINE-2).” PMID 33617632 ↗ Oct 2021 |
| Known as | ATX-101 deoxycholic acid injection | “ATX-101 deoxycholic acid injection” NCT02035267 ↗ |
| Known as | deoxycholate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00757081 ↗ |
| Known as | DWJ211 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03946592 ↗ |
| Known as | Kybella | “Deoxycholic acid (Kybella, Allergan, Irvine, CA) is an FDA-approved injectable for the treatment of excess submental fat.” NCT04054011 ↗ |
| Known as | Sodium Deoxycholate for Injection | “Phase 1-2, Multicenter, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) for the Reduction of...” NCT00618722 ↗ |
| Route | Other | “Administered via intralipomal injection.” NCT00422188 ↗ |