Drugs / ATX-101
ATX-101
also known as
KYBELLA · Sodium Deoxycholate Injection · sodium deoxycholate · deoxycholic acid · bupivacaine · Ronkyla Plus · 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 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT07237425 | Nov 2025 → Nov 2026 expected | lipoma | Glonova Pharma Co., Ltd | Recruiting | No outcome recorded |
| Phase 1 | NCT07107802 | Jul → Oct 2025 | — | Aurobac Therapeutics SAS | Completed | No outcome recorded |
| Phase 1 | NCT01632917 | Jun → Jul 2012 | — | Kythera Biopharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01462786 | Oct → Nov 2011 | — | Kythera Biopharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01319916 | Dec 2010 → Jan 2011 | — | Kythera Biopharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00835952 | Nov 2008 → Mar 2009 | — | Kythera Biopharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00618709 | Jan → Dec 2008 | — | Kythera Biopharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01320761 | — | — | Kythera Biopharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04814875 | Sep 2021 → Nov 2023 | fallopian tube cancer, high grade malignant neoplasm, ovarian cancer, primary peritoneal carcinoma | THERAPIM PTY LTD | Terminated | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06799845 | Feb → Oct 2025 | — | Allay Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT05260008 | Jun 2022 → Jan 2024 | — | Allay Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT05116683 | Jan → Oct 2022 | leiomyosarcoma, liposarcoma | Benjamin Izar | Terminated | No outcome recorded |
| Phase 2 | NCT02159729 | Feb 2009 → Dec 2015 | — | Kythera Biopharmaceuticals | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02123134 | Apr 2014 → Aug 2015 | — | Kythera Biopharmaceuticals | Completed | 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 |
| Phase not applicable1 trial | ||||||
| — | NCT03284034 | Nov 2017 → Jun 2020 | — | Northwestern University | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 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 1 | NCT01706679 Comparator | Oct 2012 → Feb 2013 | — | Kythera Biopharmaceuticals | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| 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 12 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ATX-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05116683 ↗ |
| Known as | bupivacaine | “ATX-101 (bupivacaine) implant, one-time administration into the surgical site” NCT05260008 ↗ |
| Known as | deoxycholic acid | “receive ATX-101 (deoxycholic acid) injections, 3 sessions, 30 days apart.” NCT03284034 ↗1“Injectable drug called KYBELLA® (deoxycholic acid)” NCT03510598 ↗ |
| Known as | KYBELLA | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06783621 ↗ |
| 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 ↗ |
| Known as | Sodium Deoxycholate for Injection | “Phase 1, Open-label Study of the Safety, Tolerability, and Histological Effect of Single Doses of ATX-101 (Sodium Deoxycholate for Injection) Administered in Abdominal Fat in...” NCT00835952 ↗ |
| Known as | Sodium Deoxycholate Injection | “Phase 1, Open-Label, Randomized, Safety and Pharmacokinetic Study of Two Final Formulations of ATX-101 (Sodium Deoxycholate Injection) Following Subcutaneous Injections in the...” NCT01632917 ↗3“Phase 1, Open-Label, Crossover, Safety and Pharmacokinetic Study of ATX-101 (Sodium Deoxycholate Injection) Following Subcutaneous Injections in the Submental and Abdominal Areas” NCT01462786 ↗ “ATX-101 (Sodium Deoxycholate Injection)” NCT02159729 ↗ “ATX-101 (Sodium Deoxycholate Injection)” NCT01319916 ↗ |
| Action | Inhibit | “ATX-101 is an intravenous (IV) drug which blocks the interaction of a protein called PCNA” NCT05116683 ↗ |
| Modality | Peptide | “ATX-101 is a small molecule peptide comprised of a novel human proliferating cell nuclear antigen (PCNA) interacting motif” NCT05116683 ↗ |
| Route | Subcutaneous | “Following Subcutaneous Injections in the Submental Area” NCT00618709 ↗ |
| Target | PCNA | “ATX-101, a Peptide Drug Targeting PCNA” NCT05116683 ↗ |