Regulatory status: Investigational. Not approved by the FDA or any other regulator. It is in Phase 3 for abdominal subcutaneous fat reduction. The FDA granted Fast Track and Orphan Drug designations for Dercum's disease in February 2024.
What Is CBL-514?
CBL-514 is a first-in-class injectable drug developed by Caliway Biopharmaceuticals (TWSE: 6919, founded 2012) for nonsurgical reduction of localized subcutaneous fat. Caliway is developing it as a new chemical entity under the FDA's 505(b)(1) pathway. Most localized fat treatments either destroy tissue (deoxycholic acid, cryolipolysis, thermal devices) or remove it mechanically (liposuction). CBL-514 is designed to make adipocytes undergo apoptosis, a controlled form of cell death that is cleared without the necrosis and inflammation those methods cause. As of late 2026, Caliway reports 10 completed clinical trials with more than 540 participants.
A related formulation, CBL-514D, uses the same active ingredient(s) in a different formulation and is being developed for Dercum's disease (adiposis dolorosa), a rare disorder that causes multiple painful lipomas.
Identity caveat. Caliway has not published CBL-514's chemical structure, molecular formula or CAS number. Some third-party sources describe it as a stabilized combination of resveratrol and curcumin, but Caliway has not confirmed this, and its regulatory filings refer to the Dercum's product's "active pharmaceutical ingredients" in the plural. Researchers should treat the composition as undisclosed.
Mechanism of Action
According to Caliway and its published trials, CBL-514 raises levels of the apoptosis executioner caspase-3 and shifts the Bax/Bcl-2 ratio toward cell death. The effect is dose-dependent and selective for adipocytes, and it has been shown both in cell culture and in animals. Some secondary sources say the drug inhibits DYRK1B (a kinase involved in adipogenesis and adipocyte survival). That claim traces back to Caliway's unpublished internal reports cited in the 2022 Phase 2a paper and has not been independently confirmed.
The main difference from deoxycholic acid (Kybella) is what kind of cell death occurs. Deoxycholic acid is a detergent that breaks open cell membranes without much selectivity, causing local necrosis, inflammation and, under the chin, occasional marginal mandibular nerve injury. CBL-514 is designed to trigger apoptosis inside adipocytes. Caliway's published trials report no observed necrosis or nerve injury. The intended result is fewer fat cells, not shrunken fat cells. This is why Caliway expects the effect to last, although long-term follow-up data are not yet available (see CBL-0303 below).
Clinical Development
Phase 2a (abdomen, open-label, dose-ranging): 1.2, 1.6 and 2.0 mg/cm² unit doses (180–300 mg total). At 2.0 mg/cm², abdominal fat volume fell by about 25% on ultrasound.
Phase 2 (abdomen, randomized 2:1, placebo-controlled, n=76): 69.6% of CBL-514 participants lost at least 150 mL of subcutaneous fat at 8 weeks after the final treatment, versus 0% on placebo (P<.001).
Phase 2b CBL-0204 (NCT05736107, n=108): 76.7% achieved at least a 1-grade improvement on the clinician-reported Abdominal Fat Rating Scale (CR-AFRS), versus 18.9% on placebo (P<.0001). MRI showed a −20.3% change in abdominal fat volume (about −153 mL).
Phase 2b CBL-0205 (NCT06005441, n=173, 15 US/Canada sites): 54.2% achieved at least a 20% MRI fat-volume reduction, versus 0% on placebo (p<0.00001). Mean volume fell by 166.6 mL (−22.4%), while the placebo group gained 15.7 mL.
Phase 3: SUPREME-01 (CBL-0301) enrolled its first participant on September 23, 2026 (about 320 participants, US/Canada, double-blind). Its primary endpoint is a 2-grade improvement on both the patient- and clinician-reported AFRS. SUPREME-02 (CBL-0302) received FDA IND clearance in May 2026 (about 320 participants, US/Canada/Australia). CBL-0303 (long-term follow-up) was submitted to the FDA in June 2026. Caliway expects topline Phase 3 data in 2027.
Quick Reference
Member reference tables summarize the compound's research parameters.
Research Indications
Research Protocols
As reported in cited literature and research-community logs (see Research Citations below), not a personal dosing recommendation.
This member section describes parameters reported in the research literature.
Peptide Interactions
This member section summarizes reported compound interactions and evidence limitations.
Reported Research Time Points
This member section summarizes reported research time points.
Safety Notes
Included for harm-reduction awareness only, in the event this compound is encountered outside its labeled research use. Inclusion here does not imply RUO Codes endorses, recommends, or instructs human use.
This member section discusses research safety considerations and uncertainties.