Generic deoxycholic acid injection Research Reference

Catalog classification, reference sizes, lab math links, and source-backed data. Educational use only — not medical advice.

Researched for: PepTools vendor-neutral scientific reference catalog

Cytolytic agent; bile acid compound Reference approved

Also known as: deoxycholic acid injection, deoxycholic acid 10 mg/mL injection, deoxycholic acid 20 mg/2 mL injection, ATX-101

Quick Facts

Reference Sizes
20 mg/2 mL (10 mg/mL), single-dose vial
Components
Deoxycholic acid
Storage
The FDA-labeled reference injection is stored at 20–25 °C, with permitted excursions from 15–30 °C. The generic product-specific labeling should be consulted for confirmation of storage requirements.
Solubility
Reported PubChem solubility for deoxycholic acid: approximately 0.24 g/L in water at 15 °C; soluble in solutions of alkali hydroxides or carbonates. Injectable formulation solubility is formulation-specific.

Catalog Description

Deoxycholic acid is a C24 bile acid. In the approved injectable formulation, subcutaneous administration produces local disruption of adipocyte cell membranes and cell lysis. An FDA-approved generic deoxycholic acid injection is specified as 20 mg in 2 mL, equivalent to 10 mg/mL.

Catalog descriptions reflect research context only. Not a medical claim or treatment recommendation.

Research Profile

Half-Life
Approximately 9 hours in a single-dose pharmacokinetic study of ATX-101; plasma concentrations returned to baseline or the endogenous range within 24 hours.
Onset
Rapid absorption after subcutaneous administration; median time to maximum plasma concentration was 18 minutes after a 100 mg treatment dose.
Administration Routes (Research)
Subcutaneous

Reported Research Effects

Reflects preclinical/research literature context only. Not a medical claim, dosing instruction, or treatment recommendation.

Research Notes

The approved generic product is an injectable pharmaceutical formulation, not a general-purpose laboratory reagent. The FDA clinical pharmacology review evaluated a 100 mg single subcutaneous treatment dose administered as 50 injections of 0.2 mL on a 1 cm grid; this is recorded as study-reference information only. The reference formulation contains benzyl alcohol, dibasic sodium phosphate, sodium chloride, sodium hydroxide, hydrochloric acid for pH adjustment, and water for injection; excipient composition of the generic product was not independently confirmed from the generic product label.

Supplementary research context only. Not medical advice or a treatment recommendation.

Registry Identifiers

CAS RN 83-44-3; PubChem CID 222528; molecular formula C24H40O4; molecular weight 392.57 g/mol; FDA UNII 005990WHZZ

Source-Backed Observations

FDA approved an abbreviated new drug application for deoxycholic acid injection 20 mg/2 mL (10 mg/mL) as bioequivalent and therapeutically equivalent to the reference listed drug. The FDA-labeled injectable formulation is a clear, colorless, sterile solution for subcutaneous use. Current FDA labeling limits established use to the submental region in adults; safety and effectiveness outside that region have not been established and are not recommended. The 2026 FDA labeling update added warnings concerning serious adverse reactions associated with administration outside the submental region and injection-site nodules or masses.

Reflects published research. Educational reference — not a recommendation for use.

Sources

Deoxycholic Acid Injection, ANDA 212296 Approval Letter
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212296Orig1s000ltr.pdf (accessed 2026-09-26)
KYBELLA (deoxycholic acid) injection, FDA-approved prescribing information
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206333s007lbl.pdf (accessed 2026-09-26)
Clinical Review: NDA 206333, Deoxycholic Acid
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206333Orig1s000MedR.pdf (accessed 2026-09-26)
FDA Approves Additional Information in Labeling for Kybella (Deoxycholic Acid) Injection
https://www.fda.gov/drugs/drug-safety-communications/fda-approves-additional-information-labeling-kybella-deoxycholic-acid-injection-warning-adverse (accessed 2026-09-26)
Deoxycholic Acid, CID 222528
https://pubchem.ncbi.nlm.nih.gov/compound/Deoxycholic-acid (accessed 2026-09-26)

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Research Use Only. All content is for educational and research reference only. Not medical advice, a treatment recommendation, or guidance on human use. Compounds are not FDA-approved drugs unless specifically noted.

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