Abaloparatide

Overview

Abaloparatide is an N-terminal analog of parathyroid hormone-related protein (PTHrP) and an agonist at the parathyroid hormone type 1 (PTH1) receptor. It is a synthetic 34 amino acid peptide with 41% homology to human parathyroid hormone 1-34 and human PTHrP 1-34. Abaloparatide and PTHrP share the first 21 amino acids and the receptor-activating domain. Abaloparatide is an osteoanabolic agent that stimulates bone formation. It was first approved by the FDA on April 28, 2017, for the treatment of osteoporosis in postmenopausal women and is also used to increase bone density in men with osteoporosis. In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended abaloparatide be granted marketing authorization in Europe and the drug was fully authorized by the European Commission on December 19, 2022.

Indication

Abaloparatide is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture) or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, abaloparatide reduces the risk of vertebral and nonvertebral fractures. Abaloparatide is also indicated to increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture) or patients who have failed or are intolerant to other available osteoporosis therapy.

Associated Conditions

Osteoporosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Sequential Therapies After Osteoanabolic Treatment	2023/12/11	NCT06164795	N/A	Recruiting	424 General Military Hospital
Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis	2023/12/04	NCT06154187	Phase 3	Not yet recruiting	Pharmbio Korea Co., Ltd.
Real-world Effectiveness and Cardiovascular Safety Study of Abaloparatide in Postmenopausal Women	2021/07/23	NCT04974723	N/A	Completed	Radius Health, Inc.
PTH Analog Type II Odontoid Fracture	2021/02/18	NCT04760782	Phase 2	Recruiting	David Lunardini
Supracondylar Distal Femur Fractures and Abaloparatide	2020/11/12	NCT04626141	Phase 4	Withdrawn	Daniel Horwitz
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone	2020/07/13	NCT04467983	Phase 4	Active, not recruiting	Hospital for Special Surgery, New York
Abaloparatide and Pelvic Fracture Healing	2020/01/30	NCT04249232	Phase 2	Completed	Hospital for Special Surgery, New York
Abaloparatide Before Total Knee Arthroplasty	2019/11/18	NCT04167163	Phase 4	Completed	University of Wisconsin, Madison
Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery	2019/02/15	NCT03841058	Phase 2	Recruiting	Hospital for Special Surgery, New York
A Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic Syndromes	2018/11/19	NCT03746041	Phase 1	Completed	University of Rochester

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Tymlos	Radius Health, Inc.	70539-001	SUBCUTANEOUS	3.12 mg in 1.56 mL	12/31/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Eladynos	Theramex Ireland Limited,3rd Floor, Kilmore House,Park Lane, Spencer Dock,Dublin 1, D01 YE64,Ireland	Authorised	12/12/2022

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
ELADYNOS abaloparatide 2 mg/mL solution for injection cartridge in a pre-filled pen	430937	Theramex Australia Pty Ltd	Medicine	A	11/28/2024

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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