Drugs / Deoxycholic Acid

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) KYBELLA 2015-04-29 fda.gov

Trials 18 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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
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 No outcome recorded
Phase 3 NCT01546142 Mar 2012 → May 2013 Kythera Biopharmaceuticals Completed No outcome recorded
Phase 3 NCT01542034 Feb 2012 → May 2013 Kythera Biopharmaceuticals Completed No outcome recorded
Phase 3 NCT01426373 Aug 2011 → Jun 2013 Kythera Biopharmaceuticals Completed No outcome recorded
Phase 3 NCT01294644 Jan 2011 → Feb 2012 Kythera Biopharmaceuticals Completed No outcome recorded
Phase 3 NCT01305577 Dec 2010 → Jan 2012 Kythera Biopharmaceuticals Completed No outcome recorded
Phase 41 trial
Phase 4 NCT04089722 Jul 2019 → Jun 2020 Juva Skin & Laser Center Completed No outcome recorded
Phase not applicable1 trial
NCT00757081 Jun 2008 → Dec 2009 BodyAesthetic Research Center Completed No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT07237425 Comparator Nov 2025 → Nov 2026 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 31 trial
Phase 3 NCT02163902 Background Dec 2013 → Jan 2016 Kythera Biopharmaceuticals Completed No outcome recorded

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 22 sources stand behind the page.

FieldValueCited 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

NCT04089722

NCT04054011

NCT01305577

NCT00422188

NCT06132165

NCT01294644

NCT01426373

NCT00618722

NCT01542034

NCT00608842

NCT00618618

NCT01546142

NCT02035267

NCT02007434

Known as Acide desoxycholique ChEMBL registry synonym — accepted as the source's own label CHEMBL406393
Known as Acido desoxicolico ChEMBL registry synonym — accepted as the source's own label CHEMBL406393
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) ChEMBL registry synonym — accepted as the source's own label CHEMBL406393
Known as ATX-101 deoxycholic acid injection ATX-101 deoxycholic acid injectionNCT02035267
Known as deoxycholate ClinicalTrials.gov intervention name — accepted as the source's own label NCT00757081
Known as Desoxycholic acid ChEMBL registry synonym — accepted as the source's own label CHEMBL406393
Known as DWJ211 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03946592
2

NCT04159961

NCT03224117

Known as Kybella “Deoxycholic acid (Kybella, Allergan, Irvine, CA) is an FDA-approved injectable for the treatment of excess submental fat.” NCT04054011
Known as NSC-8797 ChEMBL registry synonym — accepted as the source's own label CHEMBL406393
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
Modality Small molecule CHEMBL406393
Route Other “Administered via intralipomal injection.” NCT00422188