ATX-101

Overview

ATX-101 (medical), sodium deoxycholate for subcutaneous injection, is being evaluated as a treatment for the reduction of localized fat deposits. This includes treatment of superficial lipomas (benign tumors of soft tissue composed of mature fat cells), fat deposits in the submental region of the face/neck, and localized fat deposits in other parts of the body. Deoxycholic acid is a naturally occurring bile acid produced by the liver as one of several end products of cholesterol metabolism. As a naturally occurring component of the human body, deoxycholate is considered a ‘biocompatible’ detergent that solubilizes fat in the small intestine. ATX-101 demonstrates a relative selectivity for fat over other tissues.

Indication

Investigated for use/treatment in solid tumors.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Phase 1 Single Ascending Dose Study With ATX101	2025/08/06	NCT07107802	Not Applicable	Recruiting	Aurobac Therapeutics SAS
Study Assessing Pain Relief After Replacement of the Knee	2025/01/29	NCT06799845	Phase 2	Active, not recruiting	Allay Therapeutics, Inc.
Study Assessing Pain Relief After Replacement of the Knee	2022/03/02	NCT05260008	Phase 2	Terminated	Allay Therapeutics, Inc.
ATX-101 in Advanced Dedifferentiated Liposarcoma and Leiomyosarcoma	2021/11/11	NCT05116683	Phase 2	Terminated	Benjamin Izar
A Study to Evaluate the Combination of ATX-101 and Platinum-based Chemotherapy	2021/03/24	NCT04814875	Phase 1	Terminated	THERAPIM PTY LTD
Cryolipolysis Versus ATX-101 (Deoxycholic Acid) for Upper Back Fat	2017/09/15	NCT03284034	Not Applicable	Terminated	Northwestern University
Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101	2014/06/16	NCT02163902	Phase 3	Completed	Kythera Biopharmaceuticals
Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101	2014/06/10	NCT02159729	Phase 2	Completed	Kythera Biopharmaceuticals
Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age	2014/04/25	NCT02123134	Phase 3	Completed	Kythera Biopharmaceuticals
Evaluation of the Effect of ATX-101 on QT/QTc Intervals	2012/10/15	NCT01706679	Phase 1	Completed	Kythera Biopharmaceuticals

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
PFIZER BUPIVACAINE 0.25% w/v WITH ADRENALINE (epinephrine) 1:400,000 injection solution vial	292525	Pfizer Australia Pty Ltd	Medicine	A	10/19/2018
BUPIVADREN Bupivacaine 0.25% w/v with Adrenaline (epinephrine) 1:400,000 injection solution vial	292526	Pfizer Australia Pty Ltd	Medicine	A	10/19/2018
BUPIVACAINE 0.25% WITH ADRENALINE 1:400,000 PHEBRA bupivacaine HCl 50 mg/20 mL with adrenaline 50 microgram/20 mL solution for injection vial	408186	Phebra Pty Ltd	Medicine	A	2/8/2024
0.5% MARCAIN DENTAL with ADRENALINE 1:200,000 2.2mL injection cartridge	11954	Dentsply Sirona Pty Ltd	Medicine	A	7/31/1991
PFIZER BUPIVACAINE 0.5% w/v WITH ADRENALINE (epinephrine) 1:200,000 injection solution vial	292527	Pfizer Australia Pty Ltd	Medicine	A	10/19/2018
Pfizer (Australia) BUPIVACAINE HYDROCHLORIDE 0.25% (50mg/20mL) injection BP vial	11314	Pfizer Australia Pty Ltd	Medicine	A	8/13/1991
MARCAIN 0.125% WITH FENTANYL 1000 microgram/200mL	72870	Aspen Pharmacare Australia Pty Ltd	Medicine	A	5/3/2000
Pfizer (Australia) BUPIVACAINE HYDROCHLORIDE 0.5% (50mg/10mL) injection BP ampoule	11312	Pfizer Australia Pty Ltd	Medicine	A	8/13/1991
BUPIVACAINE SPINAL HEAVY BNM bupivacaine hydrochloride 20 mg/4 mL solution for injection ampoule	297613	Boucher & Muir Pty Ltd	Medicine	A	5/20/2019
BUPIVADREN Bupivacaine 0.5% w/v with Adrenaline (epinephrine) 1:200,000 injection solution vial	292528	Pfizer Australia Pty Ltd	Medicine	A	10/19/2018

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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