Synopsis
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1. Ba058
2. Tymlos
1. Tymlos
2. Ba058
3. Unii-avk0i6hy2u
4. Bim-44058
5. Abaloparatide [usan:inn]
6. Abaloparatide-sc
7. Avk0i6hy2u
8. Chembl4084894
9. Bdbm50246337
10. C2.29-methyl(22-l-glutamic Acid(f>e),23-l-leucine(f>l),25-l-glutamic Acid(h>e),26-l-lysine(h>k),28-l-leucine(i>l),30-l-lysine(e>k),31-l-leucine(i>l))human Parathyroid Hormone-related Protein-(1-34)-proteinamide
Molecular Weight | 3961 g/mol |
---|---|
Molecular Formula | C174H300N56O49 |
XLogP3 | -20.9 |
Hydrogen Bond Donor Count | 61 |
Hydrogen Bond Acceptor Count | 60 |
Rotatable Bond Count | 145 |
Exact Mass | 3959.2738250 g/mol |
Monoisotopic Mass | 3958.2704702 g/mol |
Topological Polar Surface Area | 1740 Ų |
Heavy Atom Count | 279 |
Formal Charge | 0 |
Complexity | 9310 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 34 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Bone Density Conservation Agents
Agents that inhibit BONE RESORPTION and/or favor BONE MINERALIZATION and BONE REGENERATION. They are used to heal BONE FRACTURES and to treat METABOLIC BONE DISEASES such as OSTEOPOROSIS. (See all compounds classified as Bone Density Conservation Agents.)
Details:
Under the licensing agreement, Radius granted Theramex the exclusive commercialization rights to Eladynos (abaloparatide), indicated for the treatment of osteoporosis in postmenopausal
Lead Product(s): Abaloparatide Acetate
Therapeutic Area: Musculoskeletal Brand Name: Eladynos
Study Phase: Approved FDFProduct Type: Peptide
Sponsor: Theramex
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 09, 2024
Lead Product(s) : Abaloparatide Acetate
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Theramex
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Radius Expands Abaloparatide License with Theramex to New Territories
Details : Under the licensing agreement, Radius granted Theramex the exclusive commercialization rights to Eladynos (abaloparatide), indicated for the treatment of osteoporosis in postmenopausal
Product Name : Eladynos
Product Type : Peptide
Upfront Cash : Undisclosed
December 09, 2024
Details:
Theramex will commercialise and distribute Eladynos (abaloparatide), a novel bone forming agent indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fractures on an exclusive basis in the European Economic Area, UK , Australia and Brazil.
Lead Product(s): Abaloparatide Acetate
Therapeutic Area: Musculoskeletal Brand Name: Tymlos
Study Phase: Approved FDFProduct Type: Peptide
Sponsor: Theramex
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 20, 2023
Lead Product(s) : Abaloparatide Acetate
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Theramex
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Theramex will commercialise and distribute Eladynos (abaloparatide), a novel bone forming agent indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fractures on an exclusive basis in the European Economic Area, UK , A...
Product Name : Tymlos
Product Type : Peptide
Upfront Cash : Undisclosed
March 20, 2023
Details:
Radius’ lead product, TYMLOS® (abaloparatide) was launched in the U.S. in 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
Lead Product(s): Abaloparatide Acetate
Therapeutic Area: Musculoskeletal Brand Name: Tymlos
Study Phase: Approved FDFProduct Type: Peptide
Sponsor: Gurnet Point Capital
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition August 15, 2022
Lead Product(s) : Abaloparatide Acetate
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Gurnet Point Capital
Deal Size : Undisclosed
Deal Type : Acquisition
Gurnet Point Capital and Patient Square Capital Complete Their Acquisition of Radius Health, Inc.
Details : Radius’ lead product, TYMLOS® (abaloparatide) was launched in the U.S. in 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
Product Name : Tymlos
Product Type : Peptide
Upfront Cash : Undisclosed
August 15, 2022
Details:
The acquisition of Radius by Gurnet Point and Patient Square provides our shareholders with attractive, immediate value at a compelling premium, in addition to the potential future upside of TYMLOS (abaloparatide) through the CVR.
Lead Product(s): Abaloparatide Acetate
Therapeutic Area: Musculoskeletal Brand Name: Tymlos
Study Phase: Approved FDFProduct Type: Peptide
Sponsor: Gurnet Point Capital
Deal Size: $890.0 million Upfront Cash: $547.0 million
Deal Type: Acquisition August 15, 2022
Lead Product(s) : Abaloparatide Acetate
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Gurnet Point Capital
Deal Size : $890.0 million
Deal Type : Acquisition
Gurnet Point Capital and Patient Square Capital Complete Their Acquisition of Radius Health, Inc.
Details : The acquisition of Radius by Gurnet Point and Patient Square provides our shareholders with attractive, immediate value at a compelling premium, in addition to the potential future upside of TYMLOS (abaloparatide) through the CVR.
Product Name : Tymlos
Product Type : Peptide
Upfront Cash : $547.0 million
August 15, 2022
Details:
The acquisition of Radius by Gurnet Point and Patient Square provides our shareholders with attractive, immediate value at a compelling premium, in addition to the potential future upside of TYMLOS (abaloparatide) through the CVR.
Lead Product(s): Abaloparatide Acetate
Therapeutic Area: Musculoskeletal Brand Name: Tymlos
Study Phase: Approved FDFProduct Type: Peptide
Sponsor: Gurnet Point Capital
Deal Size: $890.0 million Upfront Cash: $547.0 million
Deal Type: Acquisition June 23, 2022
Lead Product(s) : Abaloparatide Acetate
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Gurnet Point Capital
Deal Size : $890.0 million
Deal Type : Acquisition
Details : The acquisition of Radius by Gurnet Point and Patient Square provides our shareholders with attractive, immediate value at a compelling premium, in addition to the potential future upside of TYMLOS (abaloparatide) through the CVR.
Product Name : Tymlos
Product Type : Peptide
Upfront Cash : $547.0 million
June 23, 2022
Details:
The data for spine BMD vs. baseline showed abalo-TDS had a 7.1% increase vs. TYMLOS (abaloparatide) +10.9%, both considered clinically meaningful. Despite missing the non-inferiority margin, the transdermal system demonstrated a bone building benefit to patients.
Lead Product(s): Abaloparatide Acetate
Therapeutic Area: Musculoskeletal Brand Name: Tymlos
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 06, 2022
Lead Product(s) : Abaloparatide Acetate
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Radius Health Update on Abaloparatide Transdermal System
Details : The data for spine BMD vs. baseline showed abalo-TDS had a 7.1% increase vs. TYMLOS (abaloparatide) +10.9%, both considered clinically meaningful. Despite missing the non-inferiority margin, the transdermal system demonstrated a bone building benefit to ...
Product Name : Tymlos
Product Type : Peptide
Upfront Cash : Inapplicable
January 06, 2022
Details:
Company announced phase 3 topline results from the wearABLe study did not meet its primary endpoint evaluating the NI of BA058 (abaloparatide) in postmenopausal women with osteoporosis.
Lead Product(s): Abaloparatide Acetate
Therapeutic Area: Musculoskeletal Brand Name: Tymlos
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 12, 2021
Lead Product(s) : Abaloparatide Acetate
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Company announced phase 3 topline results from the wearABLe study did not meet its primary endpoint evaluating the NI of BA058 (abaloparatide) in postmenopausal women with osteoporosis.
Product Name : Tymlos
Product Type : Peptide
Upfront Cash : Inapplicable
August 12, 2021
Details:
Endo obtained the rights to abaloparatide-subcutaneous injection and abaloparatide-transdermal patch, a novel formulation and route of administration currently undergoing clinical development. Endo, will be responsible for all commercial activities related to abaloparatide.
Lead Product(s): Abaloparatide Acetate
Therapeutic Area: Musculoskeletal Brand Name: BA058
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Endo International
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 01, 2021
Lead Product(s) : Abaloparatide Acetate
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Endo International
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Endo Announces Licensing Agreement for Paladin Labs Inc. to Commercialize Abaloparatide in Canada
Details : Endo obtained the rights to abaloparatide-subcutaneous injection and abaloparatide-transdermal patch, a novel formulation and route of administration currently undergoing clinical development. Endo, will be responsible for all commercial activities relat...
Product Name : BA058
Product Type : Peptide
Upfront Cash : Undisclosed
May 01, 2021
Details:
The study was designed to look at the effects on bone mineral density of abaloparatide delivered via a novel transdermal device (“abaloparatide-patch”) compared with the current subcutaneous formulation, marketed as TYMLOS®.
Lead Product(s): Abaloparatide Acetate
Therapeutic Area: Musculoskeletal Brand Name: Tymlos
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 09, 2020
Lead Product(s) : Abaloparatide Acetate
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Radius Health: Enrollment Completed for Phase 3 wearABLe Trial
Details : The study was designed to look at the effects on bone mineral density of abaloparatide delivered via a novel transdermal device (“abaloparatide-patch”) compared with the current subcutaneous formulation, marketed as TYMLOS®.
Product Name : Tymlos
Product Type : Peptide
Upfront Cash : Inapplicable
August 09, 2020
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PharmaCompass offers a list of Abaloparatide Acetate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Abaloparatide Acetate manufacturer or Abaloparatide Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Abaloparatide Acetate manufacturer or Abaloparatide Acetate supplier.
PharmaCompass also assists you with knowing the Abaloparatide Acetate API Price utilized in the formulation of products. Abaloparatide Acetate API Price is not always fixed or binding as the Abaloparatide Acetate Price is obtained through a variety of data sources. The Abaloparatide Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Abaloparatide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Abaloparatide, including repackagers and relabelers. The FDA regulates Abaloparatide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Abaloparatide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Abaloparatide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Abaloparatide supplier is an individual or a company that provides Abaloparatide active pharmaceutical ingredient (API) or Abaloparatide finished formulations upon request. The Abaloparatide suppliers may include Abaloparatide API manufacturers, exporters, distributors and traders.
click here to find a list of Abaloparatide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Abaloparatide DMF (Drug Master File) is a document detailing the whole manufacturing process of Abaloparatide active pharmaceutical ingredient (API) in detail. Different forms of Abaloparatide DMFs exist exist since differing nations have different regulations, such as Abaloparatide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Abaloparatide DMF submitted to regulatory agencies in the US is known as a USDMF. Abaloparatide USDMF includes data on Abaloparatide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Abaloparatide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Abaloparatide suppliers with USDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Abaloparatide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Abaloparatide API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Abaloparatide as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Abaloparatide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Abaloparatide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Abaloparatide suppliers with NDC on PharmaCompass.
Abaloparatide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Abaloparatide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Abaloparatide GMP manufacturer or Abaloparatide GMP API supplier for your needs.
A Abaloparatide CoA (Certificate of Analysis) is a formal document that attests to Abaloparatide's compliance with Abaloparatide specifications and serves as a tool for batch-level quality control.
Abaloparatide CoA mostly includes findings from lab analyses of a specific batch. For each Abaloparatide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Abaloparatide may be tested according to a variety of international standards, such as European Pharmacopoeia (Abaloparatide EP), Abaloparatide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Abaloparatide USP).