Drugs / Kybella

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

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

Trials 4

2015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT07237425 Nov 2025 → Nov 2026 expected lipoma Glonova Pharma Co., Ltd Recruiting No outcome recorded
Phase 43 trials
Phase 4 NCT06783621 Jan 2025 → Mar 2026 — AbbVie Completed No outcome recorded
Phase 4 NCT04841551 Jul 2021 → Mar 2022 obesity disorder Beer, Kenneth R., M.D., PA Completed No outcome recorded
Phase 4 NCT03510598 Mar → Dec 2018 obesity disorder Zeltiq Aesthetics Completed No outcome recorded
Comparator or background therapy5 trials
Phase 1 NCT06300502 Comparator Apr 2025 → Feb 2027 expected neurofibroma, neurofibromatosis type 1 Massachusetts General Hospital Enrolling by invitation No outcome recorded
Phase 1 NCT06120036 Comparator Dec 2022 → Jan 2025 neurofibromatosis type 1 Massachusetts General Hospital Completed No outcome recorded
Phase 1 NCT04730583 Comparator Jun 2021 → Apr 2024 neurofibroma Massachusetts General Hospital Completed No outcome recorded
Phase 4 NCT03361176 Comparator Mar → Oct 2018 obesity disorder Goldman, Butterwick, Fitzpatrick and Groff Completed No outcome recorded
Phase 4 NCT03241563 Comparator Apr 2016 → Feb 2017 — Goldman, Butterwick, Fitzpatrick and Groff Completed No outcome recorded

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as Kybella ClinicalTrials.gov intervention name — accepted as the source's own label NCT06300502 ↗
5

NCT03510598 ↗

NCT06120036 ↗

NCT04841551 ↗

NCT06783621 ↗

NCT04730583 ↗

Known as deoxycholic acid “Injectable drug called KYBELLA® (deoxycholic acid)” NCT03510598 ↗
Known as Ronkyla Plus “Ronkyla Plus is a new formulation of sodium deoxycholate lipolysis injection.” NCT07237425 ↗
Known as sodium deoxycholate “Ronkyla Plus is a new formulation of sodium deoxycholate lipolysis injection.” NCT07237425 ↗
2

NCT03361176 ↗

NCT03241563 ↗

Route Subcutaneous “Subcutaneous Sodium Deoxycholate Injections With or Without Triamcinolone” NCT03241563 ↗