Delving into the Latest Updates on Abaloparatide with Synapse

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-

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Structure/Sequence

Sequence Code 164795

Source: *****

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

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100 Translational Medicine associated with Abaloparatide

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100 Patents (Medical) associated with Abaloparatide

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363

Literatures (Medical) associated with Abaloparatide

03 Aug 2025·Expert Opinion On Drug Safety

Comparing musculoskeletal and connective tissue disorder risks of teriparatide and abaloparatide in osteoporosis: an analysis based on FDA adverse event reporting system (FAERS)

Article

Author: Lu, Bo-Wen ; Luo, Di ; Wen, Ming-Tao ; Liu, Fei ; Li, Gang ; Li, Jia-Cheng ; Ling, Pei-Xue

BACKGROUND:

Osteoporosis (OP), characterized by low bone mass and increased fracture risk, is a prevalent skeletal disorder. Teriparatide (TP) and abaloparatide (ABL) are anabolic agents that may reduce fracture incidence, but their impact on musculoskeletal and connective tissue disorders (MCTD) risk is uncertain.

RESEARCH DESIGN AND METHODS:

A retrospective, observational disproportionality analysis was conducted utilizing FAERS data from Q1 2004 to Q3 2023, where TP or ABL was identified as the primary suspect drug. Multiple data mining algorithms, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS), were employed to detect MCTD safety signals.

RESULTS:

A total of 366,747 TP-related and 422,377 ABL-related cases were identified, predominantly among female patients aged ≥45 years. The top specific AEs involved musculoskeletal, connective tissue, and administration site disorders. Comparative analysis revealed a higher frequency of AEs related to the nervous, cardiovascular, and gastrointestinal systems for ABL compared to TP. Both drugs exhibited strong signals for arthralgia, limb pain, back pain, muscle spasms, bone pain, muscle pain, and muscle weakness.

CONCLUSION:

The analysis suggests a potential MCTD risk with TP and ABL treatment in OP patients, highlighting the need for AE monitoring and management in clinical practice. This contributes to a better understanding of the safety profiles of these anabolic medications.

01 Aug 2025·BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

An oral robotic pill reliably and safely delivers teriparatide with high bioavailability in healthy volunteers: A phase 1 study

Article

Author: Vo, April Toledo ; Imran, Mir ; Dhalla, Arvinder K. ; Battiwala, Archana ; Van Dam, Jacques ; Patel, Nidhi ; Yamaguchi, Alyson ; Fung, Leonard C. ; Myers, Joshua T. ; Dasari, Anvesh ; Gonen, Ofer M. ; Bilezikian, John P. ; Hashim, Mir A.

Aims:

The incidence of osteoporosis is projected to exceed 70 million people over the age of 65 years by 2030. Osteoanabolic agents, such as teriparatide and abaloparatide, are not only effective in reducing fracture incidence but also improve skeletal microstructure—an important need not met by antiresorptive agents. However, anabolic agents must be administered by daily subcutaneous injections which can be a challenge in older women. To address this need, we have developed an oral robotic pill (RP) designed to deliver biotherapeutics safely and painlessly.

Methods:

This report describes the results of a 2‐part Phase 1 study conducted to evaluate the safety, tolerability and pharmacokinetics of single (Part 1) and repeat doses (Part 2) of teriparatide delivered via the RP (RT‐102) in healthy and postmenopausal women.

Results:

Teriparatide, administered by the RP, was measurable in 26/29 and 63/69 of participants in Part 1 and Part 2, respectively. RT‐102 at the 20‐μg dose yielded a lower maximum observed serum concentration (98 ± 10 vs. 128 ± 20 pg mL−1), delayed time to reach maximum observed serum concentration (68 ± 15 vs. 13 ± 2 min) and higher area under the curve to infinity (342 ± 44 vs. 126 ± 29 h pg mL−1) resulting in a 3‐fold higher bioavailability than subcutaneous injection. RT‐102 was well tolerated with only 5 mild to moderate adverse events (AEs) related to the RP that resolved without intervention and no serious AEs. Drug‐related AEs were similar in severity and frequency between RT‐102 and subcutaneous teriparatide.

Conclusion:

These data demonstrate that RT‐102 can safely and reliably deliver therapeutic levels of teriparatide.

Clinicaltrials.gov:

NCT#05164614.

05 Jul 2025·JBMR Plus

The effect of abaloparatide on the proximal femur in men with osteoporosis assessed by three-dimensional dual-energy X-ray absorptiometry

Article

Author: Boxberger, John ; Mitlak, Bruce H ; Wang, Yamei ; Binkley, Neil ; Humbert, Ludovic ; Dhaliwal, Ruban

Abstract:

Abaloparatide treatment significantly increased BMD at the LS, TH, and FN compared with placebo in men with osteoporosis in the phase 3 ATOM trial. The current study used 3D-DXA modeling to evaluate the effects of abaloparatide on cortical and trabecular compartments of the proximal femur in ATOM study participants. Proximal femur DXA images were retrospectively analyzed using 3D-DXA (3D-Shaper software v2.12.0, 3D-Shaper Medical, Barcelona, Spain) to evaluate changes in bone parameters from baseline at months 6 and 12 in all randomized men from the ATOM trial. Between-group comparisons were made for percent change from baseline data based on a mixed-effect repeated-measure model with treatment, visit, treatment-by-visit interaction, and type of DXA scanner as fixed effects. Other covariates include BMI, age, and baseline values of bone parameters. Abaloparatide treatment significantly increased integral volumetric BMD (vBMD) (3.7%), trabecular vBMD (7.0%), cortical thickness (1.1%), and cortical surface BMD (1.7%) at 12 mo compared to baseline (p < .0001). Changes were greater for abaloparatide compared to placebo for all 4 parameters (p < .01). Significant increases from baseline compared to placebo in integral vBMD (2.7% vs −0.1%, p < .0001) and trabecular vBMD (6.1% vs −0.6%, p < .0001) were also observed at 6 mo. In conclusion, in men with osteoporosis, abaloparatide improved proximal femur 3D-DXA parameters broadly consistent with results in postmenopausal women in the ACTIVE study, adding to the growing data on abaloparatide bone structure effects at the hip.

75

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

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External Link

KEGG	Wiki	ATC	Drug Bank
D10885	Abaloparatide	H05AA	DB05084

R&D Status

Approved

10 top approved records.

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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.

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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

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01343004 (ACTIVE, Pubmed \| Menopause)	Phase 3	Osteoporotic Fractures	-	Abaloparatide	kdnrnlkzzq(dbnncplvie) = 8.9% dtfwhmovft (jvmuspcosy ) View more	Positive	01 May 2025
				Placebo
NCT04760782 (CTgov)	Phase 2	Fractures, Bone	22	Hard collar immobilization+Abaloparatide (Treatment Group)	oivvniqfml(uiukjawcer) = auyjfrkfsv drhkxwywlm (xptbkmddpt, pxvfvyyvuy - upsacnsdye) View more	-	19 Sep 2024
				Hard collar immobilization (Historical Control Group)	oivvniqfml(uiukjawcer) = bbydtyryjw drhkxwywlm (xptbkmddpt, yavqlnutrx - jwhrziwens) View more
NCT03512262 (ATOM, ENDO2024)	Phase 3	Osteosclerosis PINP \| CTX	228	Abaloparatide 80 µg	ymkjlnqenj(wvrdnqinht) = xsdjbjxqty idykqtusiq (smbuvrzbff ) View more	Positive	01 Jun 2024
Biospace Manual	Not Applicable	Osteoporosis	43,352	TYMLOS (abaloparatide)	uijjmdpjgn(juevtazpji) = dlcecdvyaw fskcdohqqk (zltfsgfzup ) View more	Positive	16 Apr 2024
				Teriparatide	uijjmdpjgn(juevtazpji) = ixjdwflgsp fskcdohqqk (zltfsgfzup ) View more
WCO_IOF_ESCEO2024	Not Applicable	-	-	Abaloparatide	oumoetsnpr(pimxhjjamk): 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	jgensbkbeo(ihvwovyayv) = vlrxztxrev lxtxjrcwbd (judxmwqgia, 41.8) View more	-	22 Nov 2023
WCO_IOF_ESCEO2023	Not Applicable	Osteoporosis, Postmenopausal	-	Abaloparatide	pgkcjewbbl(mdjyzitmye) = emyatgxnre gtcxkqdchs (enweldoowz ) View more	Positive	04 May 2023
				Teriparatide	pgkcjewbbl(mdjyzitmye) = ohtxfxkunj gtcxkqdchs (enweldoowz ) View more
NCT03512262 (ATOM, CTgov)	Phase 3	Primary osteoporosis \| Osteoporosis	228	Abaloparatide (Abaloparatide)	kmqekesedy(jikubwetmi) = ylguivkuyd jkcxviqhgp (yksbfwtqtb, 0.5353) View more	-	07 Apr 2023
				Placebo (Placebo)	kmqekesedy(jikubwetmi) = zmpbabwscs jkcxviqhgp (yksbfwtqtb, 0.7235) View more
NCT04064411 (CTgov)	Phase 3	Osteoporosis, Postmenopausal	511	abaloparatide (Abaloparatide-SC)	ciwycxkcgn(vjorezfnhs) = hksfafbgda fhavjtdgio (ayxoejyquw, 0.4755) View more	-	15 Feb 2023
				abaloparatide solid microstructured transdermal system (Abaloparatide-sMTS)	ciwycxkcgn(vjorezfnhs) = flxqbvarrl fhavjtdgio (ayxoejyquw, 0.4605) View more
PSAT156 (ENDO2022)	Not Applicable	Osteoporosis	146	Abaloparatide therapy	xsryykdkju(rfnlvdnhgg) = One reported fracture during the evaluation period ogshdknwkb (eiwoqjykcs ) View more	Positive	01 Nov 2022

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