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Last update 28 May 2025

Abaloparatide

Last update 28 May 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

Theramex Ireland Ltd.

Teijin Ltd.

Pharmbio Korea Co., Ltd.

+ [2]

Inactive Organization

Endo Ventures Unlimited Co.

Radius Intelligence, Inc.

Radius International, Inc.

License Organization

Ipsen SA

Pharmbio Korea Co., Ltd.

Theramex HQ U.K 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

356

Literatures (Medical) associated with Abaloparatide

01 Jun 2025·Journal of Oral Biosciences

Histochemical assessment of the anabolic effects of abaloparatide on the femoral metaphyses of ovariectomized mice

Article

Author: Shi, Yan ; Haoyu, Wang ; Yamamoto, Tomomaya ; Hasegawa, Tomoka ; Hongo, Hiromi ; Liu, Xuanyu ; Cui, Jiaxin ; Ishizu, Hotaka ; Sakakibara, Mako ; Haraguchi-Kitakamae, Mai ; Li, Weisong ; Amizuka, Norio ; Shimizu, Tomohiro ; Ohiro, Yoichi

OBJECTIVE:

To clarify the mechanism of bone anabolism induced by the parathyroid hormone-related peptide analog abaloparatide, we histochemically examined the femora of ovariectomized mice treated with abaloparatide.

METHODS:

Twelve-week-old female C57BL/6J mice underwent ovariectomies (OVX), and were then administered either abaloparatide (30 μg/kg/day: OVX+ABL group) or vehicle (OVX group) via daily intraperitoneal injection. Femora were harvested at 0, 2, 4, and 6 weeks post-administration and subjected to micro-CT imaging, TRAP, cathepsin K, ALP, and PHOSPHO1 staining, along with calcein labeling.

RESULTS:

In the OVX group, trabecular number and bone volume gradually decreased over time, whereas the OVX + ABL group maintained these values to 6 weeks after OVX. The numbers of TRAP-positive/cathepsin K-reactive osteoclasts per bone surface area were similar between the OVX and OVX + ABL group, except for a temporary increase at 4 weeks in the OVX group. In the OVX group, the areas of ALP-positive osteoblastic cells and PHOSPHO1-reactive mature osteoblasts decreased, whereas in the OVX+ABL group, ALP-positive osteoblastic cells surrounded the trabeculae, and long lines of PHOSPHO1-reactive mature osteoblasts expanded to the terminal region of the trabeculae. In addition, long continuous calcein labeling was seen on slightly convex new bone, indicating modeling-based bone formation in the OVX + ABL group. The bone formation rate/bone surface ratio and the total length of modeling-based bone formation sites were higher in the OVX + ABL group than in the OVX group.

CONCLUSION:

Abaloparatide suppresses bone loss following ovariectomy by promoting both remodeling-based and modeling-based bone formation.

29 Apr 2025·Endocrine Metabolic & Immune Disorders-Drug Targets

Male Osteoporosis: A Comprehensive Review of Treatment Approaches in Modern Pharmacotherapy and Traditional Chinese Medicine Interventions

Article

Author: Chin, Kok-Yong ; Chen, Guiju ; Wang, Yuanzhong ; Wong, Sok Kuan ; Wang, Yuxia ; Zhou, Zaifu ; Zhao, Wenjian

Male osteoporosis presents a significant yet often overlooked health concern, characterised by reduced bone mass and increased fracture risk. This medical problem warrants comprehensive treatment approaches integrating modern pharmacotherapy and traditional Chinese medicine (TCM) interventions. This review aims to provide an extensive overview of the treatment options available for male osteoporosis, encompassing both conventional medications and traditional Chinese herbal remedies. Modern pharmacotherapy offers treatments to mitigate bone loss, enhance bone density, and reduce fracture risk in male osteoporotic patients. These options include bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab, raloxifene, calcitonin, and testosterone replacement therapy. The efficacy of these medications is well-established; however, their potential side effects cannot be overlooked. Meanwhile, TCM interventions offer promising alternatives with minimal adverse effects. Various TCM treatments, such as Duhuo Jisheng Decoction, Liuwei Dihuang Decoction, Erxian Decoction, Jintiange Capsule, Qianggu Capsule, Xianling Gubao Capsule, Zuogui Pill, Qing’e Pill, and Gusongbao, have demonstrated efficacy in improving bone health and reducing fracture risk in male osteoporotic patients. Additionally, alternative treatments, including acupuncture, tuina, and infrared laser therapy, provide further therapeutic avenues for managing male osteoporosis, highlighting the holistic approach of TCM. Future research should focus on evaluating the efficacy, safety, and potential synergistic effects of combining different modalities to enhance the treatment outcomes for male osteoporotic patients. Although the efficacy of TCM is notable, it largely relies on evidence-based medicine and experiential use, with fewer double-blinded studies. Therefore, more vigorous studies are needed to establish the role of TCM as a valid complementary treatment option for osteoporosis.

01 Apr 2025·CLINICAL ORAL IMPLANTS RESEARCH

Abaloparatide Enhances Bone Regeneration in Extraction Socket Dental Implant Defects: An Experimental In Vivo Study

Article

Author: Yilmaz, Birtan ; Giannobile, William V. ; Latimer, Jessica ; Mitlak, Bruce ; Feher, Balazs ; Lanske, Beate ; Shiba, Takahiko ; Fretwurst, Tobias ; Kostenuik, Paul

ABSTRACT:

Objective:

Abaloparatide (ABL) is a synthetic parathyroid hormone‐related protein analog developed as an anabolic drug to treat osteoporosis. ABL increases bone mineral density (BMD) of the long bones and spine; however, the influence of ABL on alveolar bone regeneration remains unknown. This study assessed the effects of systemic ABL administration on tooth extraction socket healing and dental implant osseointegration in a preclinical rodent model.

Methods:

Sprague‐Dawley rats received daily subcutaneous injection of ABL (25 μg/kg) or vehicle (VEH) at the time of maxillary first molar (M1) extraction surgery; animals underwent either: (1) unilateral M1 extraction followed by sacrifice at 10 or 42d or (2) bilateral M1 extraction followed by staged implant placement in osteotomies with standardized defects and sacrifice at 21 or 28d.

Results:

Micro‐computed tomography (micro‐CT) analysis demonstrated that ABL increased bone volume fraction (p = 0.004) and bone mineral density (BMD) (p = 0.006) of regenerated extraction sockets at 42d. Micro‐CT of the femur validated systemic effects of ABL, showing greater trabecular BMD after 6 (p < 0.01), 9 (p < 0.001), and 14 (p < 0.001) weeks of treatment. Histomorphometry confirmed a higher mineralized bone area with ABL treatment in extraction sockets at 42d (p = 0.03) and in the regenerated peri‐implant bone at 21d post‐implant placement (p = 0.01) compared to control.

Conclusion:

Systemic ABL administration enhances osteogenesis in extraction sockets prior to implant placement and accelerates peri‐implant bone formation in the early phase of healing in the present rodent model.

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	rtozkvaxjf(fhzyyecvef) = 8.9% lotrjlviyb (iubkuheozz ) View more	Positive	01 May 2025
				Placebo
NCT04760782 (CTgov)	Phase 2	Fractures, Bone	22	Hard collar immobilization+Abaloparatide (Treatment Group)	exvxxoksyl(ewuxgyxtgd) = rnwgszwnqg vqhljozizx (tckilrhxqt, ifyhlejbbo - zjqtuqyxvj) View more	-	19 Sep 2024
				Hard collar immobilization (Historical Control Group)	exvxxoksyl(ewuxgyxtgd) = inwhlpctkg vqhljozizx (tckilrhxqt, xkoilgtvhf - ueyrzqeycm) View more
ENDO2024	Not Applicable	PTHrP	-	Exogenous PTHrP	kjuolpteiq(ywwclhqchy) = PTHrP improved the stimulation index of Min6 cells and enhanced their sensitivity to glucose ttgundiujo (rejebqaeqd ) View more	-	01 Jun 2024
				PTHrP (Control Min6 cells)
NCT03512262 (ATOM, ENDO2024)	Phase 3	Osteosclerosis PINP \| CTX	228	Abaloparatide 80 µg	peargqtkwq(bblnnoqayw) = glsonwqdhv cyyhrdkmep (thsphnznce ) View more	Positive	01 Jun 2024
Biospace Manual	Not Applicable	Osteoporosis	43,352	TYMLOS (abaloparatide)	tsnyelwmfx(zsifzmydme) = eyaywiicfn lmlsbukkyq (orzhvwwlhn ) View more	Positive	16 Apr 2024
				Teriparatide	tsnyelwmfx(zsifzmydme) = lvubkowems lmlsbukkyq (orzhvwwlhn ) View more
WCO_IOF_ESCEO2024	Not Applicable	-	-	Abaloparatide	bpdpbhfynw(vjkmpskuhs): HR = 0.83 (95% CI, 0.7 - 0.98), P-Value = 0.03	Positive	11 Apr 2024
				Teriparatide
WCO_IOF_ESCEO2024	Not Applicable	-	58	Abaloparatide	qxixqmpyba(xgyxgyqzqw) = lllewvrwtl qfynuxjlcn (cwnfhgfvww ) View more	Positive	11 Apr 2024
NCT04366726 (CTgov)	Phase 1	Osteoporosis, Postmenopausal	22	abaloparatide-sMTS	afgiurzgse(skafdzolhr) = fhnbzqtebb sxlxgoughr (avxouptajf, 41.8) View more	-	22 Nov 2023
FRI693 (ENDO2023)	Not Applicable	Hepatocellular Carcinoma PTHrP	-	Zoledronic acid	cpdstdknld(jjarzdljzg) = ahsobzqbdp mtdcgxilut (lecryxpgpv ) View more	-	05 Oct 2023
WCO_IOF_ESCEO2023	Not Applicable	Osteoporosis, Postmenopausal	-	Abaloparatide	cpuymaowab(hwathbhkho) = revivrpszl wbwgmrhlzg (vmrselvmwh ) View more	Positive	04 May 2023
				Teriparatide	cpuymaowab(hwathbhkho) = ecpqppaxhj wbwgmrhlzg (vmrselvmwh ) View more

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