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Last update 06 Dec 2025

Abaloparatide

Last update 06 Dec 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

Radius Health, Inc.Theramex Ireland Ltd.

Teijin Ltd.

+ [2]

Inactive Organization

Radius Intelligence, Inc.

Radius International, Inc.ENDO VENTURES LTD

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

/ CompletedNot 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

373

Literatures (Medical) associated with Abaloparatide

01 Dec 2025·Current Osteoporosis Reports

Efficacy of Osteoanabolic Agents in Type 2 Diabetes Mellitus: a Meta-analysis and Review of the Literature

Review

Author: Bhadada, Sanjay K ; Banerjee, Mainak ; Yadav, Urmila ; Pal, Rimesh ; Prasad, Trupti N

PURPOSE:

To synthesize evidence on the efficacy of osteoanabolic therapies (teriparatide, abaloparatide, romosozumab) in adults with type 2 diabetes mellitus (T2D), focusing on changes in bone mineral density (BMD) and fractures, and to explore whether responses differ between people with and without diabetes.

FINDINGS:

Following PRISMA guidelines, we searched PubMed/MEDLINE, Embase and Scopus databases till April 30, 2025 (PROSPERO: CRD420251044760). Five studies met criteria (n = 1,469 with T2D; n = 12,052 without diabetes): two post hoc analyses of randomized controlled trials (RCTs) (ACTIVE and ARCH trials) and three observational studies. Using random-effects model, osteoanabolic therapy in T2D increased lumbar spine BMD by a mean difference (MD) of 5.06% (95% CI: 1.62, 8.50; I²=93.3%). Sensitivity analysis restricted to RCTs demonstrated a larger, highly consistent effect at lumbar spine (MD 7.49%, 95% CI: 6.56, 8.41; I²=0%). Femoral neck BMD increased by 2.61% (95% CI: 1.84, 3.38; I²=0%). Evidence for fracture outcomes in T2D was limited to a single RCT (ACTIVE), in which non-vertebral fractures were reduced with abaloparatide versus placebo (p = 0.04), whereas new vertebral fractures were not different between groups. Two observational studies showed that in people with T2D, osteoanabolic agents improved BMD as much as, or more than, in non-diabetic individuals, while fracture rates were mostly similar between the groups. Osteoanabolic agents yield meaningful BMD gains in T2D, particularly at lumbar spine, with modest improvements at femoral neck. Limited fracture data suggest possible benefit but remain underpowered, underscoring the need for diabetes-specific RCTs with fracture endpoints.

28 Oct 2025·JOURNAL OF BONE AND MINERAL RESEARCH

Advances in Parathyroid Hormone-based medicines

Review

Author: Bonnet, Anne-Laure ; Mannstadt, Michael ; Aboishava, Lizaveta

Abstract:

Parathyroid hormone (PTH), produced by the parathyroid glands, plays a critical role in the regulation of calcium and phosphate homeostasis, acting primarily on bone and kidney to maintain serum calcium levels within a narrow range. Parathyroid hormone also plays important roles in bone remodeling by directly stimulating osteoblasts and osteocytes, integrating its calcemic response with stimulation of bone formation. Through the RANK/RANK-ligand system, these cells activate osteoclasts, promoting a balanced process of bone formation and resorption that maintains bone density and strength. Dysregulation of PTH, as seen in disorders such as hyper- and hypoparathyroidism, can lead to significant clinical complications. In recent years, major advancements have been made in the development of PTH analogs, aimed at leveraging PTH’s physiological effects on bone to treat conditions such as osteoporosis and hypoparathyroidism. While PTH promotes both bone formation and bone resorption, the net outcome may be a gain or loss of bone mass, depending largely on the administration pattern of PTH or its analogs. When PTH is given intermittently (eg, as once-daily subcutaneous injection), bone formation is favored. Continuous administration of PTH or chronic elevation of blood PTH levels as seen in primary hyperparathyroidism tend to promote bone resorption. Parathyroid hormone analogs, such as teriparatide (PTH(1-34)) and the PTHrP analog abaloparatide, administered once daily, have significant efficacy in stimulating bone formation, making them valuable options for the treatment of osteoporosis. Given this capacity to improve bone structure, these analogs hold broader therapeutic potential for other skeletal disorders, including fracture healing and oral bone repair, which expands the scope of PTH-based therapies beyond osteoporosis. Long-acting PTH analogs have applications in treating hypoparathyroidism, offering an alternative to conventional treatment with calcium and active vitamin D. This article reviews the molecular mechanisms of approved and emerging PTH-based medicines, their clinical applications, and recent advances in optimizing their therapeutic potential. We also discuss ongoing research aimed at developing next-generation PTH analogs with improved efficacy for skeletal and metabolic disorders.

01 Oct 2025·JOURNAL OF CRANIOFACIAL SURGERY

The Effect of Abaloparatide on New Bone Formation in Critical Calvarial Defectsin a Postmenopausal Model

Article

Author: Özdoğan, Zeynep ; Özmen, Özlem ; Kizildağ, Alper

Objective::

We examined the effect of locally administered abaloparatide (ABL), alone or combined with an autogenous graft, on new bone formation in critical-sized calvarial defects in postmenopausal rats.

Method::

Thirty-two ovariectomized rats were divided into 4 equal groups: control (C), ABL, autogenous (O), and ABL+O. Each rat received an 8-mm calvarial defect with a trephine drill. After 8 weeks, rats were sacrificed and bone regeneration was evaluated using microCT and histologic analyses. Alkaline phosphatase (ALP), β-catenin, bone morphogenetic protein 2 (BMP-2), collagen-1, osteocalcin, osteonectin, osterix (OST), osteoprotegerin (OPG), receptor ligand for nuclear factor-kappaB (RANKL), transforming growth factor-beta (TGF-β), and vascular endothelial growth factor (VEGF) were evaluated immunohistochemically.

Result::

Significant improvements were found in bone healing in the ABL and O groups, compared with the C group. The ABL+O group reached the highest values in terms of total healing area, defect closure rate, and new bone formation. Histopathologic analysis showed that the ABL+O group had the most osteoblasts and the fewest osteoclasts. Immunohistochemical analysis showed that ALP, β-catenin, and BMP-2. Collagen-1, osteocalcin, osteonectin, OST, OPG, RUNX2, TGF-β, and VEGF expressions were increased in the ABL+O group, and RANKL expression was highest in the C group. Micro-CT analysis showed that the ABL+O group had the best results in terms of bone density, trabecular thickness, and trabecular number.

Conclusion::

Abaloparatide+O showed a high therapeutic potential in bone regeneration by optimizing the healing of critical-sized bone defects in postmenopausal rats. These findings suggest that ABL+O may be an effective treatment option in clinical applications.

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	tnplbufaor(iztneazmpu) = 8.9% eroxkoegmz (bytqdgafom ) View more	Positive	01 May 2025
				Placebo
NCT04760782 (CTgov)	Phase 2	Fractures, Bone	22	Hard collar immobilization+Abaloparatide (Treatment Group)	blaqptafzt(wyylcvpbbb) = uygxxkhupw pvhhzgvjji (qfmxdxedai, zpqgwmzkpn - lzkdutdvip) View more	-	19 Sep 2024
				Hard collar immobilization (Historical Control Group)	blaqptafzt(wyylcvpbbb) = jjcmvjzxqx pvhhzgvjji (qfmxdxedai, glqofkfowp - wxnwtmiqko) View more
NCT03512262 (ATOM, ENDO2024)	Phase 3	Osteosclerosis PINP \| CTX	228	Abaloparatide 80 µg	wjarpcxszl(qxrvuoxjyf) = grjicxbage aalcnsvche (dbikpfuwnd ) View more	Positive	01 Jun 2024
Biospace Manual	Not Applicable	Osteoporosis	43,352	TYMLOS (abaloparatide)	kqzkbipyrb(giwwaealcz) = gciwuxtyzi qztfogatab (iftipsvmyl ) View more	Positive	16 Apr 2024
				Teriparatide	kqzkbipyrb(giwwaealcz) = qeujrecfmj qztfogatab (iftipsvmyl ) View more
WCO_IOF_ESCEO2024	Not Applicable	-	-	Abaloparatide	jvnkuxubpa(vtzzqnpzwf): 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	vbtnyrkbfo(ayboilydps) = ygieramker ulvphurpzq (vsxawnmmxa, 41.8) View more	-	22 Nov 2023
WCO_IOF_ESCEO2023	Not Applicable	Osteoporosis, Postmenopausal	-	Abaloparatide	pchztpgudf(grjigmwsdv) = wkfnmkpyjd zhsbutuzwd (gkkxfclbhs ) View more	Positive	04 May 2023
				Teriparatide	pchztpgudf(grjigmwsdv) = uhkjgmljbh zhsbutuzwd (gkkxfclbhs ) View more
NCT03512262 (ATOM, CTgov)	Phase 3	Primary osteoporosis \| Osteoporosis	228	Abaloparatide (Abaloparatide)	ghnkknctxl(wxrtjfxlog) = dopniqptos aeynnvlyyf (igbudgtbhr, 0.5353) View more	-	07 Apr 2023
				Placebo (Placebo)	ghnkknctxl(wxrtjfxlog) = kqdatupebw aeynnvlyyf (igbudgtbhr, 0.7235) View more
NCT04064411 (CTgov)	Phase 3	Osteoporosis, Postmenopausal	511	abaloparatide (Abaloparatide-SC)	xcojfpeezm(vxayntkrss) = ikpizmfyqu mnelgsaxwt (fwlvnlfmpu, 0.4755) View more	-	15 Feb 2023
				abaloparatide solid microstructured transdermal system (Abaloparatide-sMTS)	xcojfpeezm(vxayntkrss) = qauewpifil mnelgsaxwt (fwlvnlfmpu, 0.4605) View more
PSAT156 (ENDO2022)	Not Applicable	Osteoporosis	146	Abaloparatide therapy	qvmzgvqwwt(miidmdhjyy) = One reported fracture during the evaluation period sxsmnnbyxp (alhdwhurqg ) View more	Positive	01 Nov 2022

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