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Last update 23 Aug 2025

Abaloparatide

Last update 23 Aug 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

Abaloparatide (USAN/INN), Abaloparatide Acetate, Abaloparatide patch

+ [17]

Target

PTH1R

Action

agonists

Mechanism

PTH1R agonists(Parathyroid hormone receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic DiseaseSkin and Musculoskeletal Diseases

Active Indication

OsteoporosisOsteoporosis, Postmenopausal

Inactive Indication

Fractures, BoneOsteoporotic FracturesPrimary osteoporosis+ [1]

Originator Organization

Ipsen SA

Active Organization

Teijin Ltd.Theramex Ireland Ltd.

Radius Health, Inc.

+ [2]

Inactive Organization

Endo Ventures Unlimited Co.

Radius Intelligence, Inc.

Radius International, Inc.

License Organization

Ipsen SA

Pharmbio Korea Co., Ltd.

Theramex HQ UK Ltd.

+ [8]

Drug Highest PhaseApproved

First Approval Date

United States (28 Apr 2017),

Osteoporosis, Postmenopausal

Regulation-

Structure/Sequence

Sequence Code 164795

Source: *****

Clinical Trials associated with Abaloparatide

NCT06898060

/ Not yet recruitingPhase 3

A Multicenter, Randomized, Open-label, Parallel Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture

The purpose of this study is to evaluate the efficacy and safety of QLG2128 in the treatment of postmenopausal women with osteoporosis and at high risk of fracture.

Start Date01 Jun 2025

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

CTR20244889

/ Active, not recruitingNot Applicable

评估受试制剂阿巴帕肽注射液与参比制剂阿巴帕肽注射液（Tymlos®）作用于健康成年受试者的单中心、开放、随机、单剂量、交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, crossover bioequivalence study to evaluate the test formulation abaparatide injection and the reference formulation abaparatide injection (Tymlos®) in healthy adult subjects

主要研究目的研究空腹状态下皮下注射受试制剂阿巴帕肽注射液与参比制剂阿巴帕肽注射液（Tymlos®）在健康成年受试者体内的药代动力学，评价空腹状态下皮下注射两种制剂的生物等效性。次要研究目的研究受试制剂阿巴帕肽注射液在健康受试者中的安全性。

[Translation]

Primary study objective To study the pharmacokinetics of the test formulation abaparatide injection and the reference formulation abaparatide injection (Tymlos®) in healthy adult subjects after subcutaneous injection in the fasting state, and to evaluate the bioequivalence of the two formulations after subcutaneous injection in the fasting state. Secondary study objective To study the safety of the test formulation abaparatide injection in healthy subjects.

Start Date02 Jan 2025

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

NCT04626141

/ WithdrawnPhase 4IIT

Time to Healing, Loss of Fixation, and Loss of Alignment in Supracondylar Distal Femur Fractures Among a Geriatric Population Treated With Abaloparatide: A Double-Blind Placebo Controlled Study

Supracondylar femur fractures in the geriatric population present a unique challenge to the orthopaedic surgeon both in terms of fixation, healing, and final extremity axial alignment. Pulsed dosing of parathyroid hormone derivatives (Forteo) has been shown to increase bone mass, and several studies in Europe have demonstrated its benefit as an adjuvant for fracture healing. Abaloparatide represents a new compound which similarly offers great potential for accelerating fracture healing, especially healing associated with callous formation. This is a randomized, double blind placebo-controlled trial to compare a group of patients being treated for supracondylar distal femur fractures who receive abaloparatide (n=38) with a control group of patients who receive a placebo (n=38).

Start Date01 Jun 2024

Sponsor / Collaborator

Geisinger Clinic

[+1]

100 Clinical Results associated with Abaloparatide

100 Translational Medicine associated with Abaloparatide

100 Patents (Medical) associated with Abaloparatide

371

Literatures (Medical) associated with Abaloparatide

01 Sep 2025·Bone Reports

Abaloparatide effects on BMD in acetabular regions corresponding to DeLee and Charnley zones in women with postmenopausal osteoporosis

Article

Author: Pearman, Leny ; Winzenrieth, Renaud ; Torkelson, Jared ; Bostrom, Mathias P ; Wang, Yamei ; Humbert, Ludovic ; Krohn, Kelly ; Sheth, Neil P ; Boxberger, John I

Background:

Acetabular bone loss in patients with osteoporosis is associated with increased risk of acetabular fragility fractures, significant morbidity, and can increase risk of complications in patients undergoing total hip arthroplasty. The anabolic osteoporosis treatment abaloparatide increases total hip areal bone mineral density (BMD), but its effect on acetabular BMD is unknown.

Methods:

Anatomical landmarks were identified in DXA scans from a random subgroup of postmenopausal women with osteoporosis (PMO) treated with abaloparatide 80 μg/d or placebo (n = 250/group) from the phase 3 ACTIVE trial to virtually place a hemispherical shell model of an acetabular cup and define regions of interest corresponding to DeLee and Charnley zones 1 (R1), 2 (R2), and 3 (R3). Changes in BMD from baseline at 6 and 18 months were calculated. Statistical significance was tested using a mixed model with repeated measures. Local mean changes in BMD were depicted by alignment of DXA scans via intensity-based registration onto a reference scan.

Results:

Abaloparatide significantly increased acetabular areal BMD in all three DeLee and Charnley zones at 6 and 18 months versus placebo. Mean BMD increases with abaloparatide were 8.38 % (R1), 7.25 % (R2), and 9.73 % (R3) at 18 months. BMD increases were homogenously distributed throughout the regions. With placebo, localized losses in BMD were noted after 18 months.

Conclusions:

Abaloparatide treatment rapidly and progressively increases BMD in acetabular zones in PMO.

Clinical trial number:

NCT01343004.

11 Aug 2025·ORTHOPEDICS

Prescription Trends by Orthopedic Surgery Provider: Review of the Medicare Part D Prescribers - by Provider and Drug, 2013-2021.

Review

Author: Chansky, Howard ; Bartoletta, John ; Kubsad, Sanjay ; Fernando, Navin ; Manner, Paul ; Hernandez, Nicholas

BACKGROUND:

We characterize outpatient prescribing trends of orthopedic surgery providers in the United States.

MATERIALS AND METHODS:

A retrospective analysis of the Medicare Part D Prescribers - by Provider and Drug was conducted between 2013 and 2021, including anti-osteoporotic medications (AOMs), antibiotics, opioids, and nonsteroidal anti-inflammatory drugs (NSAIDs). Outcomes included claims, claims per 1,000 prescribers, combined annual growth rate, and percentage growth.

RESULTS:

Claims for AOMs decreased from 29,024 in 2013 to 12,500 in 2021. Claims for alendronate, ibandronate, risedronate, and teriparatide all significantly decreased, whereas claims for abaloparatide and romosozumab significantly increased (P<0.05). Antibiotic claims increased from 304,817 (2013) to 580,736 (2021). Claims for amoxicillin, amoxicillin/clavulanic acid, cefadroxil, cephalexin, clindamycin, doxycycline, mupirocin, penicillin V, and sulfamethoxazole/trimethoprim significantly increased, whereas use of azithromycin, ciprofloxacin, levofloxacin, and vancomycin significantly decreased (P<0.05). Claims for opioids decreased from 3,224,572 (2013) to 2,070,423 (2021). Use of hydrocodone/acetaminophen, oxycodone/acetaminophen, and tramadol/acetaminophen also significantly decreased (P<0.05). Use of oxycodone and oxycodone myristate significantly increased (P<0.05). Claims for fentanyl, methadone, and morphine all significantly decreased (P<0.05). Claims for NSAIDs increased from 1,300,279 (2013) to 1,796,419 (2021). Claims for celecoxib, diclofenac, ibuprofen, ketorolac, and meloxicam all significantly increased, whereas claims for etodolac, indomethacin, nabumetone, naproxen, piroxicam, and sulindac all significantly decreased (P<0.05).

CONCLUSION:

In line with national guidelines, claims for NSAIDs are increasing and claims for opioid pain medications and AOMs are decreasing. Claims for outpatient antibiotics are increasing, which is of significant concern, given renewed focus on antibiotic stewardship.

11 Aug 2025·Nature Reviews Rheumatology

Parathyroid hormone receptor agonists in the management of osteoporosis.

Review

Author: Zakraoui, Leith ; Ebeling, Peter R ; McClung, Michael ; McCloskey, Eugene ; Kanis, John A ; Beaudart, Charlotte ; Campusano, Claudia ; Mkinsi, Ouafa ; Hiligsmann, Mickaël ; Njeze, Ngozi ; Silverman, Stuart ; Burlet, Nansa ; Dawson-Hughes, Bess ; Kaufman, Jean-Marc ; Bruyère, Olivier ; Al-Daghri, Nasser ; Cavalier, Etienne ; D'Amelio, Patrizia ; Casado, Enrique ; Matijevic, Radmila ; Cooper, Cyrus ; Reginster, Jean-Yves ; Kurth, Andreas ; Veronese, Nicola ; Albergaria, Ben Hur ; Cortet, Bernard ; Rannou, François ; Alokail, Majed ; Brandi, Maria Luisa ; Fuggle, Nicholas ; Rizzoli, René ; Harvey, Nicholas C ; Tüzün, Şansın ; Curtis, Elizabeth M ; Chandran, Manju ; Radermecker, Régis P

Parathyroid hormone (PTH) regulates bone homeostasis. Intermittent exposure to PTH results in bone formation being greater than bone resorption, and this effect has been harnessed through the development of agonists of the PTH and PTH-related protein type 1 receptor (PTH1R) to treat osteoporosis. Teriparatide, an analogue of the first 34 amino acids of PTH, and abaloparatide, which resembles PTH-related protein (PTHrP) in structure, are PTH1R agonists currently in clinical use. Both medications have been shown to increase bone mineral density at the lumbar spine, femoral neck and total hip. Randomized controlled trials with teriparatide or abaloparatide have also provided evidence of reduction in vertebral and non-vertebral fractures. The ACTIVE trial suggested slightly greater efficacy for major osteoporotic fractures (as an exploratory end point) for abaloparatide than for teriparatide. A similar potential superiority was suggested for hip fracture in a real-world, observational study. Side effects of these medications are usually transient, and although a risk of osteosarcoma was suggested by studies using murine models, no such risk has been observed in extensive human studies. Overall, both teriparatide and abaloparatide have demonstrated convincing clinical effectiveness and cost-effectiveness, with a reassuring safety profile. Potential differences in their effects on bone mineral density and their antifracture effects offer avenues for differentiation but require further validation in appropriately designed studies.

News (Medical) associated with Abaloparatide

03 Jan 2025

·www.pharmaindustrial-india.com

Pharmanovia Signs In-Licensing Deal for Osteoporosis Treatment with Radius Health

Pharmanovia has signed an exclusive in-licensing agreement with Radius Health, Inc for osteoporosis treatment, abaloparatide, which is marketed in the US as TYMLOS®. Under the terms of the agreement Pharmanovia will be responsible for clinical, regulatory and commercial activities across key markets in the Asia Pacific region, specifically China, Singapore, Thailand, Indonesia, Vietnam, Taiwan, Hong Kong, Malaysia, Macau and the Philippines. Abaloparatide is a human parathyroid hormone related peptide analogue indicated by the FDA for the treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. Abaloparatide is also indicated to increase bone density in men with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. “We are thrilled to expand our portfolio and bring to the Asia Pacific region such an important and innovative osteoporosis treatment. This deal recognises the strength of our commercial model in APAC, and China in particular, where we have one of the leading osteoporosis commercial platforms. With Tymlos® we will serve a broader patient population, providing osteoporosis solutions in the high, medium and low risk categories, further addressing unmet needs and meeting bone health challenges,” said James Burt, CEO, Pharmanovia. “This collaboration partners two companies that share a commitment to improving the lives of patients with osteoporosis. With Pharmanovia’s expertise in osteoporosis and their proven track record of success in these territories, we can look forward to significantly expanding access of abaloparatide to patients in need of osteoporosis treatment options,” said Scott Briggs, CEO, Radius Health.

License out/in

02 Jan 2025

·www.accesswire.com

Radius Pharmaceuticals Announces Licensing Agreement with Pharmanovia to Register and Commercialize Abaloparatide in China and Select Asia Pacific Territories

BOSTON, MA / ACCESSWIRE / January 2, 2025 / Radius Pharmaceuticals, Inc., a wholly owned subsidiary of Radius Health, Inc. (\"Radius\" or the \"Company\"), a specialty biopharmaceutical company focused on bone health and related areas, announced today it has granted Pharmanovia the exclusive commercialization rights to abaloparatide, a novel bone forming agent indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. The licensing agreement covers markets in the Asia Pacific region, specifically China, Singapore, Thailand, Indonesia, Vietnam, Taiwan, Hong Kong, Malaysia, Macau and the Philippines. Abaloparatide is marketed in the U.S. by Radius under the tradename TYMLOS®.\"We are very pleased to enter into a partnership with Pharmanovia with the goal of making abaloparatide available to patients in additional global markets,\" said Scott Briggs, Chief Executive Officer of Radius. \"This collaboration partners two companies that share a commitment to improving the lives of patients with osteoporosis. With Pharmanovia\'s expertise in osteoporosis and their proven track record of success in these territories, we can look forward to significantly expanding abaloparatide access to patients in need of osteoporosis treatment options.\"\"We are thrilled to expand our portfolio and bring to the Asia Pacific region such an important and innovative osteoporosis treatment,\" said James Burt, Chief Executive Officer of Pharmanovia. \"This deal recognizes the strength of our commercial model in APAC, and China in particular, where we have one of the leading osteoporosis commercial platforms.\"Under the terms of the Licensing Agreement, Radius would be eligible to receive an upfront payment as well as regulatory and commercial milestones plus tiered royalties on net sales.About Radius:Radius is a global biopharmaceutical company dedicated to transforming the future for underserved, global patient populations in bone health and related areas. Radius\' lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 to increase bone density in men with osteoporosis at high risk for fracture. Radius also has an exclusive licensing and distribution agreement for the U.S. rights to BINOSTO® (alendronate sodium) effervescent tablet for oral solution, expanding the Company\'s presence in bone health.About Pharmanovia:Pharmanovia is a global lifecycle management healthcare company. Our purpose is to make medicines fit for tomorrow, to improve the lives of patients globally. We do this by rediscovering, repurposing or re-engineering established medicines or by bringing to market novel medicines to improve patient outcomes and experiences. With a diverse and growing team in over 160 countries across the globe, we deliver high-quality solutions, ethically and sustainably, across our four core therapeutic areas - Endocrinology, Neurology, Cardiovascular and Oncology both in rare and established diseases or conditions.Contacts:Al Medwar: Senior Vice President, Business and Corporate Development, Radius Email: [email protected]SOURCE: Radius Health Related Documents:

Drug ApprovalLicense out/in

09 Dec 2024

·www.accesswire.com

Radius Pharmaceuticals Expands Abaloparatide Licensing Agreement with Theramex Granting Additional Commercialization Rights Including Mexico, Canada, South Africa, Israel, and Russia

BOSTON, MA / ACCESSWIRE / December 9, 2024 / Radius Pharmaceuticals, Inc., a wholly owned subsidiary of Radius Health, Inc. ("Radius" or the "Company"), a specialty biopharmaceutical company focused on bone health and related areas, announced today it has granted Theramex the exclusive commercialization rights to ELADYNOS® (abaloparatide), a novel bone forming agent indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures, for Mexico, Canada, Israel, South Africa, and Russia. Theramex will also have the opportunity to commercialize ELADYNOS® in other agreed upon unpartnered regions. Abaloparatide is marketed in the U.S. by Radius under the tradename TYMLOS®.Under the License Agreement, Radius will receive an upfront and milestone payment plus tiered royalties."Theramex has been an excellent collaborative partner, and we are very pleased to expand our abaloparatide partnership to include additional important global markets," said Scott Briggs, Chief Executive Officer of Radius. "Radius is committed to making abaloparatide accessible to patients, and the expansion of our existing partnership helps provide access to additional patients in need of osteoporosis treatment options.""Following the launch of abaloparatide in Europe, we are excited to bring this innovative product to more patients globally and drive further growth through our direct markets and our commercial partnerships. This agreement expands our successful relationship with Radius, and we look forward to continuing our close collaboration," said Rob Stewart, Chief Executive Officer of Theramex.In addition to these new territories, Theramex will continue to commercialize and distribute ELADYNOS® on an exclusive basis in the European Economic Area, the United Kingdom, Australia, and Brazil. ELADYNOS® received approval in the European Economic Area in December 2022 and Australia in November 2024 and has been launched in select countries.About Radius:Radius is a global biopharmaceutical company dedicated to transforming the future for underserved, global patient populations in bone health and related areas. Radius' lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 to increase bone density in men with osteoporosis at high risk for fracture. Radius also has an exclusive licensing and distribution agreement for the U.S. rights to BINOSTO® (alendronate sodium) effervescent tablet for oral solution, expanding the Company's presence in bone health.About Theramex:Theramex is a leading global specialty pharmaceutical company dedicated to women and their health. Theramex supports women at different stages of their lives by providing a broad portfolio of innovative and established brands covering osteoporosis, contraception, fertility, menopause and uterine health. Theramex's commitment is to listen to and understand its patients, serve their needs and offer healthcare solutions to help improve their lives. Theramex's vision is to be a lifetime partner for women and the healthcare professionals who treat them by providing patient-focused and effective solutions that care for and support women through different stages of their life.Contacts:Al Medwar: Senior Vice President, Business and Corporate Development, Radius Email: [email protected]Edward Rees: Chief Corporate Development Officer, TheramexEmail: to [email protected]SOURCE: Radius Health

Drug ApprovalLicense out/in

100 Deals associated with Abaloparatide

External Link

KEGG	Wiki	ATC	Drug Bank
D10885	Abaloparatide	H05AA	DB05084

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Osteoporosis	Japan	Teijin Ltd.	31 Aug 2022
Osteoporosis, Postmenopausal	United States	Radius Health, Inc.	28 Apr 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Primary osteoporosis	Phase 3	United States	Radius Health, Inc.	03 May 2018
Primary osteoporosis	Phase 3	Italy	Radius Health, Inc.	03 May 2018
Primary osteoporosis	Phase 3	Poland	Radius Health, Inc.	03 May 2018
Fractures, Bone	Phase 3	United States	Radius Health, Inc.	01 Apr 2011
Fractures, Bone	Phase 3	Argentina	Radius Health, Inc.	01 Apr 2011
Fractures, Bone	Phase 3	Brazil	Radius Health, Inc.	01 Apr 2011
Fractures, Bone	Phase 3	Czechia	Radius Health, Inc.	01 Apr 2011
Fractures, Bone	Phase 3	Denmark	Radius Health, Inc.	01 Apr 2011
Fractures, Bone	Phase 3	Estonia	Radius Health, Inc.	01 Apr 2011
Fractures, Bone	Phase 3	Hong Kong	Radius Health, Inc.	01 Apr 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01343004 (ACTIVE, Pubmed \| Menopause)	Phase 3	Osteoporotic Fractures	-	Abaloparatide	wjymuergrh(zsakesuvwr) = 8.9% xwrgmmdzrv (ylisfvjsyx ) View more	Positive	01 May 2025
				Placebo
NCT04760782 (CTgov)	Phase 2	Fractures, Bone	22	Hard collar immobilization+Abaloparatide (Treatment Group)	abzqzyqqsx(skdhwjcrtn) = ixizflsnsc woaouzbymt (vgclzsnlun, oyvzpfuczf - greqetnemu) View more	-	19 Sep 2024
				Hard collar immobilization (Historical Control Group)	abzqzyqqsx(skdhwjcrtn) = osloxzpnfm woaouzbymt (vgclzsnlun, vycmioybsv - ssccfhellq) View more
NCT03512262 (ATOM, ENDO2024)	Phase 3	Osteosclerosis PINP \| CTX	228	Abaloparatide 80 µg	buvfvtrvbg(pvjscdtktw) = raqbznrmol xwqqzczbha (bkwttcugma ) View more	Positive	01 Jun 2024
Biospace Manual	Not Applicable	Osteoporosis	43,352	TYMLOS (abaloparatide)	hmvhfwvcjh(wcvurrmxiw) = vidqbcjkoo fgnmytecll (hkyeazkbcb ) View more	Positive	16 Apr 2024
				Teriparatide	hmvhfwvcjh(wcvurrmxiw) = tgvnqwubpq fgnmytecll (hkyeazkbcb ) View more
WCO_IOF_ESCEO2024	Not Applicable	-	-	Abaloparatide	yessyrrekf(fmyeqgrwke): HR = 0.83 (95% CI, 0.7 - 0.98), P-Value = 0.03	Positive	11 Apr 2024
				Teriparatide
NCT04366726 (CTgov)	Phase 1	Osteoporosis, Postmenopausal	22	abaloparatide-sMTS	shlzuzmvpt(zmapzwxxkd) = vfclwlfedl uewuocurzd (hjsdrmxwir, 41.8) View more	-	22 Nov 2023
WCO_IOF_ESCEO2023	Not Applicable	Osteoporosis, Postmenopausal	-	Abaloparatide	tczwiylczg(btzsxunioe) = eymgyxarnl kmwrzqgdll (cyedqpxjtr ) View more	Positive	04 May 2023
				Teriparatide	tczwiylczg(btzsxunioe) = ztuvzxctcg kmwrzqgdll (cyedqpxjtr ) View more
NCT03512262 (ATOM, CTgov)	Phase 3	Primary osteoporosis \| Osteoporosis	228	Abaloparatide (Abaloparatide)	ochgxpxssj(uzonhqystm) = jrzjcsdndt hxwyzhssuk (bnlzxeoujv, 0.5353) View more	-	07 Apr 2023
				Placebo (Placebo)	ochgxpxssj(uzonhqystm) = hljnfxwuhm hxwyzhssuk (bnlzxeoujv, 0.7235) View more
NCT04064411 (CTgov)	Phase 3	Osteoporosis, Postmenopausal	511	abaloparatide (Abaloparatide-SC)	flsqlyrzgr(umxmmwzxfj) = ykbgtcumbx yzxbzkwjtb (uxzryqhirb, 0.4755) View more	-	15 Feb 2023
				abaloparatide solid microstructured transdermal system (Abaloparatide-sMTS)	flsqlyrzgr(umxmmwzxfj) = lnfpzpuqen yzxbzkwjtb (uxzryqhirb, 0.4605) View more
PSAT156 (ENDO2022)	Not Applicable	Osteoporosis	146	Abaloparatide therapy	idkbcmudfw(tiiyuvlexs) = One reported fracture during the evaluation period caejwkzwxw (fopnaiorhw ) View more	Positive	01 Nov 2022

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