CBL-514 History and Updates

48 events · 2018 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
48
Trial Milestones
0
Pivotal Publications
CBL-514 — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2019202020212022202320242025202620272028Trial: NCT07608757 2027-02-28 → 2028-02-29 (primary completion)Trial: NCT07526974 2026-10-31 → 2027-08-31 (primary completion)Trial: NCT07140939 2026-07-31 → 2027-05-31 (primary completion)Trial: NCT07608770 2026-06-30 → 2027-04-30 (primary completion)Trial: NCT06303570 2024-11-27 → 2026-03-23 (primary completion)Trial: NCT06005441 2023-11-10 → 2024-10-18 (primary completion)Trial: NCT05736107 2023-05-30 → 2024-05-20 (primary completion)Trial: NCT05836779 2023-05-10 → 2023-11-29 (primary completion)Trial: NCT05632926 2023-01-09 → 2023-05-03 (primary completion)Trial: NCT05387733 2022-10-03 → 2023-04-03 (primary completion)Trial: NCT04897412 2022-02-14 → 2023-02-22 (primary completion)Trial: NCT05234736 2022-02-11 → 2022-06-09 (primary completion)Trial: NCT04575467 2020-12-09 → 2021-11-15 (primary completion)Trial: NCT04698642 2020-02-03 → 2020-11-12 (primary completion)Trial: NCT04699669 2018-11-27 → 2019-08-20 (primary completion)Results posted — 2024-03-28 Trial results posted: NCT04575467 A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1)Results posted — 2026-05-22 Trial results posted: NCT05234736 A Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteerstoday (2026-06-08)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-08Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for CBL-514 since 2018, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (1)

2026

Upcoming & expected milestones

Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07608770
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07140939
A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07526974
A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat ( SUPREME-02 )
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07608757
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07608770
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07526974
A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat ( SUPREME-02 )
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07608757
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat

Past events

2026
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07608770
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
Results posted· ClinicalTrials.gov
Trial results posted: NCT05234736
A Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06303570
A Study to Evaluate the Efficacy and Safety of CBL-514 Compared to Placebo in Participants With Dercum's Disease Lipomas
2025
2024
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06303570
A Study to Evaluate the Efficacy and Safety of CBL-514 Compared to Placebo in Participants With Dercum's Disease Lipomas
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05736107
A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
Results posted· ClinicalTrials.gov
Trial results posted: NCT04575467
A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1)
2023
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06005441
A Phase 2b Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat.
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05736107
A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05836779
A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 2)
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04897412
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 2)
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05632926
A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 1)
2022
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05387733
A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT04897412
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 2)
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05234736
A Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers
2021
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04575467
A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1)
2020
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT04575467
A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1)
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04698642
A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CBL-514 Injection for Reducing Convexity or Fullness of Abdominal
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT04698642
A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CBL-514 Injection for Reducing Convexity or Fullness of Abdominal
2019
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT04699669
A Phase 1 Study to Evaluate the Safety and Tolerability of CBL-514 Injection on Convexity or Fullness of Abdominal Subcutaneous Fat in Healt
2018
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT04699669
A Phase 1 Study to Evaluate the Safety and Tolerability of CBL-514 Injection on Convexity or Fullness of Abdominal Subcutaneous Fat in Healt

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.