Delving into the Latest Updates on Abaloparatide with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

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

+ [16]

Target

PTH1R

Mechanism

PTH1R agonists(Parathyroid hormone receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic DiseaseSkin and Musculoskeletal Diseases

Active Indication

OsteoporosisOsteoporosis, Postmenopausal

Inactive Indication

Fractures, BoneOsteoporotic Fractures

Originator Organization

Ipsen SA

Active Organization

Teijin Ltd.Theramex Ireland Ltd.

Radius Health, Inc.

+ [1]

Inactive Organization

Endo Ventures Ltd.

Radius Intelligence, Inc.

Radius International, Inc.

Drug Highest PhaseApproved

First Approval Date

US (28 Apr 2017),

Osteoporosis, Postmenopausal

Regulation-

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Gene Sequence

Sequence Code 164795

Source: *****

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 Ventures

[+1]

NCT06154187 / Not yet recruitingPhase 3

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis

This clinical trial was multicenter, randomized, double-blind, placebo-controlled, parallel, phase III bridge study.

Start Date01 Feb 2024

Sponsor / Collaborator

Pharmbio Korea Co., Ltd.

JPRN-UMIN000052340 / RecruitingNot ApplicableIIT

Searching study for comparative examination in Forteo and OSTABALO in a proximal femoral fracture patient - Forteo vs OSTABALO

Start Date01 Nov 2023

Sponsor / Collaborator-

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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362

Literatures (Medical) associated with Abaloparatide

01 Dec 2024·ENDOCRINOLOGY AND METABOLISM CLINICS OF NORTH AMERICA

Latest on Anabolic Agents for Osteoporosis Treatment

Review

Author: di Filippo, Luigi ; Rosen, Clifford J. ; Rosen, Clifford J

In the last decades, novel therapeutics with anabolic bone properties have been developed and are currently used in the management of osteoporosis particularly in patients with high-risk of fragility fractures. These drugs include PTH-Related Analogues, teriparatide and abaloparatide, and the anti-sclerostin agent romosozumab, this latter drug currently approved only in female patients. Their efficacies in preventing fragility fractures are widely demonstrated and their potential serious side effects were progressively downgraded, including risk of malignancies in teriparatide- and cardiovascular events in romosozumab-users, respectively. Further data are warranted about their efficacy in glucocorticoids-induces osteoporosis and fracture healings.

01 Nov 2024·Bioactive Materials

Zinc finger-inspired peptide-metal-phenolic nanointerface enhances bone-implant integration under bacterial infection microenvironment through immune modulation and osteogenesis promotion

Article

Author: Pan, Jiezhou ; Yin, Yun ; Gan, Xueqi ; Fang, Jie ; He, Yunxiang ; Qi, Hexu ; Guo, Junling ; Xu, Lin ; Li, Yifei ; Li, Yu

Orthopedic and dental implantations under bacterial infection microenvironment face significant challenges in achieving high-quality bone-implant integration. Designing implant coatings that incorporate both immune defense and anti-inflammation is difficult in conventional single-functional coatings. We introduce a multifunctional nanointerface using a zinc finger-inspired peptide-metal-phenolic nanocoating, designed to enhance implant osseointegration under such conditions. Abaloparatide (ABL), a second-generation anabolic drug for treating osteoporosis, can be integrated into the design of a zinc-phenolic network constructed on the implant surface (ABL@ZnTA). Importantly, the phenolic-coordinated Zn²⁺ ions in ABL@ZnTA can act as zinc finger motif to co-stabilize the configuration of ABL through multiple molecular interactions, enabling high bioactivity, high loading capacity (1.36 times), and long-term release (>7 days) of ABL. Our results showed that ABL@ZnTA can modulate macrophage polarization from the pro-inflammatory M1 towards the anti-inflammatory M2 phenotype, promoting immune osteogenesis with increased OCN, ALP, and SOD 1 expression. Furthermore, the ABL@ZnTA significantly reduces inflammatory fibrous tissue encapsulation and enhances the long-term stability of the implants, indicated by enhanced binding strength (6 times) and functional connectivity (1.5-3 times) in the rat bone defect model infected by S. aureus. Overall, our research offers a nano-enabled synergistic strategy that balances infection defense and osteogenesis promotion in orthopedic and dental implantations.

01 Nov 2024·Endocrine Practice

Comparative Effectiveness of Abaloparatide and Teriparatide in Women 50 Years of Age and Older: Update of a Real-World Retrospective Analysis

Article

Author: Mitlak, Bruce H ; Rizzoli, René ; Reginster, Jean-Yves ; Wang, Yamei ; Chiodo, Joseph ; Curtis, Jeffrey R ; Mitlak, Bruce H. ; Cortet, Bernard ; DeSapri, Kristi T ; LaBaume, Clayton T. ; Tabatabai, Laila ; LaBaume, Clayton T ; Curtis, Jeffrey R. ; DeSapri, Kristi T. ; Cosman, Felicia

BACKGROUND:

Abaloparatide and teriparatide are osteoanabolic treatments indicated for postmenopausal women and men with osteoporosis at high risk of fracture. In the Abaloparatide Comparator Trial In Vertebral Endpoints study, bone mineral density improvements were significantly greater with abaloparatide compared to teriparatide at the total hip and femoral neck. We conducted a retrospective claims study to examine the incidences of hip and nonvertebral fractures and cardiovascular events in women aged ≥50 years initiating abaloparatide or teriparatide therapy, expanding on a previous retrospective claims study.

METHODS:

This retrospective observational study used anonymized claims data from ICON's Symphony Health, PatientSource for women aged ≥ 50 years with ≥ 1 prescription fill for abaloparatide or teriparatide. The index date was the date of the initial prescription dispensed. Times to first hip fracture, nonvertebral fracture, and serious cardiovascular event were compared between logistic regression-based propensity score-matched cohorts and in predefined subgroups by age, prior antiresorptive use, and prior fracture using Cox proportional hazards models.

RESULTS:

Patients (21 676 per cohort) were well matched on 73 baseline parameters. Forty-five percent of patients in the abaloparatide arm and 47% in the teriparatide arm were exposed to treatment for longer than 12 months. Over 18 months (+ 30 days follow-up), 245 (1.1%) and 296 (1.4%) women in the abaloparatide and teriparatide cohorts, respectively, had a hip fracture (HR [95% CI] 0.83 [0.70, 0.98]; P = .027); 947 (4.4%) and 1078 (5.0%) had a nonvertebral fracture (0.88 [0.80, 0.96]; P = .003). There were no significant treatment-subgroup interactions (P ≥ .2). Cardiovascular events were similar between groups.

CONCLUSIONS:

There were significantly lower rates of hip and nonvertebral fractures with abaloparatide compared to teriparatide, which were consistent across subgroups. No differences in cardiovascular safety were noted between cohorts.

59

News (Medical) associated with Abaloparatide

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

15 Aug 2024

·pmlive.com

NICE recommends Theramex’s Eladynos to treat bone disease after menopause

The National Institute for Health Care and Research has recommended Theramex’s Eladynos (abaloparatide) as an option for treating bone disease after menopause. Available on the NHS in England in three months, the drug is set to benefit more than 14,000 people in the UK who are seeking treatment for osteoporosis after menopause, if there is a very high risk of fracture. Osteoporosis, a bone disease that affects 3.8 million people in the UK, develops when bone mineral density and bone mass decrease, or when the quality or structure of bone changes, leading to a decrease in bone strength that can increase the risk of broken bones or fractures. The disease particularly affects older women after menopause, as oestrogen, the hormone important for maintaining bone density and strength, decreases and bone density reduces, making broken bones more common. Other treatments for the disease include bisphosphonates such as alendronic acid and ibandronic acid, Eli Lilly’s selective oestrogen receptor modulator, Evista (raloxifene), parathyroid hormone treatments including teriparatide, and biological medicines including Amgen’s Prolia (denosumab) and Amgen/UCB’s Evenity (romosozumab). NICE’s decision was based on patients descriptions of how debilitating osteoporosis can be and how it all impacts day-to-day life, impairing mental and physical health. Theramex’s Eladynos is designed to increase bone density by stimulating the cells that produce new bone while also reducing the risk of fracture, providing an alternative for patients who have not responded to or cannot tolerate usual treatment options. Proven to be more clinically and cost-effective, the alternative treatment option comes as a pre-filled pen that is injected into the muscle through the skin. Prior to this, in March, Bayer shared positive long-term results from the late-stage OASIS 3 study, which supported the use of its investigational non-hormonal menopause drug, elinzanetant, to treat moderate-to-severe vasomotor symptoms (VMS), such as hot flashes, which are reported by up to 80% of women during the menopausal transition. In April, a Canadian study published in Neurology revealed that early menopause and a higher risk of cardiovascular disease could be linked to cognitive decline later in life.

Clinical ResultPhase 3Drug Approval

09 Aug 2024

·www.pharmaceutical-technology.com

NICE supports Theramex’s Eladynos for post-menopause osteoporosis

Lower levels of oestrogen during menopause increases the risk of developing osteoporosis. Credit: Miss Ty via Shutterstock. Theramex’s Eladynos (abaloparatide) will be available for menopausal women with osteoporosis in England within three months, following positive guidance from The National Institute for Health and Care Excellence (NICE). The drug, which is marketed by Radius Health as Tymlos in the US, increases bone density by stimulating the cells that make new bone and this reduces the risk of fracture. It is an injection that comes as a pre-filled pen that people can self-administer at home once a day. Women’s health company Thermax acquired Eladynos through a March 2023 exclusive licensing agreement with Radius. Under the terms of the deal, Theramex can commercialise Eladynos in the European Economic Area, the UK, Australia, and Brazil. In April 2017, the injection was approved by the US Food and Drug Administration (FDA) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 for the treatment of men with osteoporosis at high risk for fracture. Menopause can accelerate bone loss and increase the risk of osteoporosis due to the decline in oestrogen levels, which are crucial for maintaining bone density. The usual treatment for osteoporosis after menopause in people with a very high risk of fracture includes UCB and Amgen ’s Evenity (romosozumab) or Eli Lilly’s Forsteo (teriparatide). See Also: Eli Lilly boosts sales forecast by $3bn as diabetes and weight loss drugs propel revenue Recursion and Exscientia merge to form drug discovery company Monoclonal antibody Evenity works by inhibiting sclerostin to increase bone formation and simultaneously reducing bone resorption. It was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2020. In April 2022, NICE reversed its previous decision from November 2021 and recommended Evenity, after its earlier concerns about cost were addressed. The drug pulled in $1.16m in 2023, as per Amgen’s financials. Despite the recommendation for Evenity, some patients cannot tolerate it due to side effects such as osteonecrosis, and they stop taking the drug. Forsteo works in a similar but not identical manner to Eladynos by acting as a synthetic form of parathyroid hormone (PTH), stimulating bone formation by activating osteoblasts. Eladynos, a synthetic peptide that is a PTH-related peptide analogue, offers a different binding profile and may provide greater efficacy according to some studies. NICE has said that Eladynos could benefit more than 14,000 people in England. According to GlobalData, the osteoporosis market is forecast to generate $17.9bn across the seven major markets (US, UK, France, Germany, Spain, Italy, and Japan) by 2033. GlobalData is the parent company of Pharmaceutical Technology. In the announcement accompanying the recommendation, NICE’s chief medical officer Jonathan Benger said: “Our focus is on enabling access to care that improves quality of life while offering value to the taxpayer. Abaloparatide has been found by our independent committee to be clinically and cost-effective at reducing the risk of fracture, giving people more independence and therefore a better quality of life.”

Drug ApprovalLicense out/inAcquisition

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	JP	Teijin Ltd.	31 Aug 2022
Osteoporosis, Postmenopausal	US	Radius Health, Inc.	28 Apr 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoporotic Fractures	Phase 3	US	Radius Health, Inc.	20 Sep 2018
Fractures, Bone	Phase 3	US	Radius Health, Inc.	01 Apr 2011
Fractures, Bone	Phase 3	AR	Radius Health, Inc.	01 Apr 2011
Fractures, Bone	Phase 3	BR	Radius Health, Inc.	01 Apr 2011
Fractures, Bone	Phase 3	CZ	Radius Health, Inc.	01 Apr 2011
Fractures, Bone	Phase 3	DK	Radius Health, Inc.	01 Apr 2011
Fractures, Bone	Phase 3	EE	Radius Health, Inc.	01 Apr 2011
Fractures, Bone	Phase 3	HK	Radius Health, Inc.	01 Apr 2011
Fractures, Bone	Phase 3	LT	Radius Health, Inc.	01 Apr 2011
Fractures, Bone	Phase 3	PL	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


NCT04760782 (CTgov)	Phase 2	Fractures, Bone	22	Hard collar immobilization+Abaloparatide (Treatment Group)	eiqtpwoxmq(vajtxxvmew) = yusqekronb iehbjnqyjq (wtvrpxnzfj, ftnmniamst - drztuwdbqt) View more	-	19 Sep 2024
				Hard collar immobilization (Historical Control Group)	eiqtpwoxmq(vajtxxvmew) = krbvjmkkwv iehbjnqyjq (wtvrpxnzfj, weqflcfmpf - hkaepgabmw) View more
Biospace Manual	Not Applicable	Osteoporosis	43,352	TYMLOS (abaloparatide)	uyuowjgiju(bwadfrkqnt) = wpdqzjsael wcqfwviioq (rwgxdxdydr ) View more	Positive	16 Apr 2024
				Teriparatide	uyuowjgiju(bwadfrkqnt) = iykqzriafi wcqfwviioq (rwgxdxdydr ) View more
NCT04366726 (CTgov)	Phase 1	Osteoporosis, Postmenopausal	22	abaloparatide-sMTS	unfzppnrds(wfdutwfbuq) = vybjlzboif gcamzcjwdn (szsxfwraao, xbcltyiesi - zftfweigoa) View more	-	22 Nov 2023
NCT03512262 (ATOM, CTgov)	Phase 3	Osteoporosis	228	Abaloparatide (Abaloparatide)	gnqzladwxl(frdvbzxjpi) = tvucxhlkhv ordnmaefqr (zuxssuyuzj, tsoxmrbibv - tlsdfvytjs) View more	-	07 Apr 2023
				Placebo (Placebo)	gnqzladwxl(frdvbzxjpi) = rrrxlyfxnf ordnmaefqr (zuxssuyuzj, xtylvxzykd - lpvtklkpoz) View more
NCT04064411 (CTgov)	Phase 3	Osteoporosis, Postmenopausal	511	abaloparatide (Abaloparatide-SC)	fjkyrpoeym(jzqwtnmreu) = yytgnveaga tcvawtoswk (txtwhuqygq, ohyyqegiip - sncpgzrajw) View more	-	15 Feb 2023
				abaloparatide solid microstructured transdermal system (Abaloparatide-sMTS)	fjkyrpoeym(jzqwtnmreu) = bfpupdrrsv tcvawtoswk (txtwhuqygq, uoifkwyzvn - ttwrrdoiue) View more
NCT03512262 (ATOM, GlobeNewswire) Manual	Phase 3	Osteoporosis	228	Abaloparatide	lzqrahayxe(uppdxklkfa) = zhauxotvsx vdwdlfvbnr (tksgkaaqdy )	Positive	18 Oct 2021
				Placebo	lzqrahayxe(uppdxklkfa) = kjajdtstgf vdwdlfvbnr (tksgkaaqdy )
NCT03710889 (CTgov)	Phase 3	Osteoporotic Fractures \| Osteoporosis, Postmenopausal	23	Abaloparatide	cdmdgbbhax(txankuudbf) = xwueqnoolj qayiyinidv (ypxtcegjkb, eyxsdekueu - urfmufulzf) View more	-	15 Oct 2021
NCT01343004 \| NCT01657162 (Pubmed \| J Clin Endocrinol Metab)	Phase 3	Osteoporosis, Postmenopausal	-	Abaloparatide	xjtxszzqqw(kydvktrpqe) = ftlvohmnjh ipirpsggah (vlxeumafud )	-	01 Mar 2020
				Alendronate	xjtxszzqqw(kydvktrpqe) = tqssxgfycn ipirpsggah (vlxeumafud )
ACR2017	Not Applicable	Glucocorticoid-induced osteoporosis	32	Abaloparatide 5 μg/kg	uobqmmybmw(jjjfjqdndk) = kdjexdgapb icnxkplmmk (yuktojwbop )	Positive	07 Nov 2017
NCT01343004 (ACTIVE, CTgov)	Phase 3	Osteoporosis, Postmenopausal \| Fractures, Bone	2,463	Placebo (Placebo)	dwpwmynvmw(dxtcdpucuh) = ldmfkpkpva myktgyxppw (hbvduvyvty, qtnyhpkmcw - drupqyupxo) View more	-	01 Mar 2017
				BA058 80 mcg (BA058 80 mcg (Abaloparatide))	dwpwmynvmw(dxtcdpucuh) = asdmlpyjsi myktgyxppw (hbvduvyvty, zyhptpivhu - qhifvnrxjf) View more