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Details:
USFDA approved biosimilar, Kauliv (human teriparatide hormone), for the treatment of both men and postmenopausal women with osteoporosis who are at high risk for having broken bones or fractures.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: Kauliv
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2022
Details:
EB613 (teriparatide) is the first and most advanced oral, daily tablet formulation of synthetic hPTH (1-34), which is being evaluated for the treatment of osteoporosis.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: EB613
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 26, 2024
Details:
Forteo-Generic (teriparatide) is a parathyroid hormone analog, (PTH 1-34), which is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: Forteo-Generic
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2023
Details:
EB613 (teriparatide) is first-in-class oral PTH(1-34) peptide biosimilar, which is being evaluated in phase 2 clinical trials for the treatment of Osteoporosis.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: EB613
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2023
Details:
Teriparatide Injection, a single-patient-use pre-filled pen and a parathyroid hormone analog, is used for the treatment of osteoporosis in the United States.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: Teriparatide-Generic
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Ambio
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 21, 2023
Details:
Teva got approval for generic version of Forteo (teriparatide injection) in the United States, which is indicated to treat osteoporosis among certain women and men.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: Forteo-Generic
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2023
Details:
EB613 (oral PTH (1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for osteoporosis.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: EB613
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2023
Details:
EXT608 is a long-acting derivative of parathyroid hormone (PTH). Developed using ExtendBio’s D-VITylation® platform, the compound is fully active at the PTH receptor upon injection for the treatment of hypoparathyroidism.
Lead Product(s): Teriparatide
Therapeutic Area: Endocrinology Product Name: EXT608
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2023
Details:
EB613 is the first oral, once daily mini tablet presentation of synthetic hPTH (1-34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo®, which requires daily SC injections.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: EB613
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 03, 2023
Details:
EB613 (teriparatide) is an oral, daily tablet which stimulates new bone formation on trabecular and cortical bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity. It is being investigated for post-menopausal osteoporosis.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: EB613
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2023
Details:
RT-102 (Parathyroid Hormone) is being developed for the treatment of osteoporosis. The study achieved all of its endpoints, with repeat doses of RT-102 being generally well tolerated and delivering drug with high reliability to participants via the RaniPill™ GO.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: RT-102
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 05, 2023
Details:
The study achieved all of its endpoints, with repeat doses of RT-102 (parathyroid hormone) being generally well tolerated and delivering drug with high reliability to participants via the RaniPill™ GO.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: RT-102
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2022
Details:
EB613 is the first oral, daily tablet formulation of synthetic hPTH (1-34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo® which has been the leading anabolic treatment of osteoporosis.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: EB613
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: U.S. Food and Drug Administration
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2022
Details:
EB613 is an oral formulation of synthetic hPTH (1-34 teriparatide), a peptide consisting of the first 34 amino acids of PTH which represent the functional region. Subcutaneous Forteo® (teriparatide injection) has been the leading anabolic treatment of osteoporosis since 2002.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: EB613
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 12, 2022
Details:
RT-102, RaniPill capsule containing proprietary formulation of human PTH analog PTH (1-34) for potential treatment of osteoporosis achieved all of its endpoints, with RT-102 being generally well-tolerated and demonstrating high oral bioavailability of Rani’s PTH analog.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: RT-102
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 10, 2022
Details:
The financing agreement is expected to support the continued advancement of the RaniPill platform and ongoing clinical development of the Company’s drug pipeline including RT-102.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: RT-102
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: Avenue Venture Opportunities Fund
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 08, 2022
Details:
EB613 is an oral formulation of synthetic hPTH (1-34), (teriparatide), a peptide consisting of the first 34 amino acids of PTH which represent the functional region.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: EB613
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 26, 2022
Details:
EB613 is an oral formulation of synthetic hPTH (1-34), (teriparatide), a peptide consisting of the first 34 amino acids of PTH which represent the functional region, for the Treatment of Osteoporosis.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: EB613
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 18, 2022
Details:
Patent application for EB613 (teriparatide) address an optimized platform technology intended to be utilized for future therapeutic applications, for the treatment of osteoporosis.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: EB613
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2022
Details:
In preclinical studies, RT-102, an oral formulation of the human parathyroid hormone delivered via RaniPill™ capsule demonstrated a pharmacokinetic profile comparable to published data of PTH(1-34) injections for the treatment of osteoporosis.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: RT-102
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2022
Details:
Sondelbay (teriparatide), is a self-administered, once-a-day subcutaneous injection for patients with osteoporosis using a pen device, is indicated for treatment of osteoporosis.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: Sondelbay
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 28, 2022
Details:
Technology is utilized in Entera’s EB613 oral PTH drug for osteoporosis and several other molecules now in development by Entera and in collaboration with pharmaceutical companies.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: EB613
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2021
Details:
EB613 (PTH 1-34), an oral formulation of human parathyroid hormone (1-34), or PTH, for the treatment of osteoporosis. PTH 1-34 currently available and may reflect a favorably lower bone remodeling rate with EB613.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: EB613
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2021
Details:
EB613 is an oral formulation of human parathyroid hormone (1-34), or PTH, and is positioned to be the first oral bone building (anabolic) product to treat osteoporosis patients.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: EB613
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2021
Details:
Oral PTH 1-34 products utilizing Entera’s platform technology currently in advanced clinical stages for osteoporosis and hypoparathyroidism.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: EB613
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2021
Details:
Livogiva is a new presentation of teriparatide, the only bone anabolic treatment for osteoporosis, which has been developed as a pre-filled pen making it easy to use for patients at high risk of fractures.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: Livogiva
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 18, 2021
Details:
Rani Therapeutics platform technology converts injectable drugs like PTH and adalimumab into pills. Rani has conducted early human studies with adalimumab and exenatide to confirm high bioavailability with the Rani delivery approach.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: RT-102
Highest Development Status: PreclinicalProduct Type: Peptide
Partner/Sponsor/Collaborator: BofA Securities
Deal Size: $69.0 million Upfront Cash: Undisclosed
Deal Type: Series E Financing December 10, 2020
Details:
The Phase 2 clinical trial of EB613 is a dose-ranging, placebo-controlled study in postmenopausal female subjects with osteoporosis, or low bone mineral density (BMD), and is being conducted at four leading medical centers in Israel.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: EB613
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
Grünenthal and Teva have reached an exclusive agreement for the marketing, distribution, and promotion of teriparatide (Tetridar) in the Spanish market.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: Tetridar
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Teva Pharmaceutical Industries
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 18, 2020
Details:
Entera's intend to move EB613 development program into a Phase 2b or Phase 3 pivotal clinical trial.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: EB613
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 10, 2020
Details:
Antares development partner Teva, launched Teriparatide Injection (“teriparatide”), the generic version of Eli Lilly’s brand product Forsteo® featuring the Antares multi-dose pen platform in Austria, Croatia, Hungary,
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2020
Details:
The grant was conferred for the development of a long acting parathyroid hormone – PTH(1-34) – that can be administered once-weekly for treatment of hypo-parathyroidism.
Lead Product(s): Teriparatide
Therapeutic Area: Endocrinology Product Name: PTH(1-34)
Highest Development Status: PreclinicalProduct Type: Peptide
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Funding July 07, 2020
Details:
Entera Bio received an approval from the IRBs at the clinical sites for the amendment to its Phase 2 protocol to include the testing of higher doses of EB613.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: EB613
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2020
Details:
Adalvo recently entered into a commercialization agreement with a multinational pharmaceutical company to commercialize PF708, upon receipt of marketing authorization, in certain countries in Latin America.
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: Livogiva
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 26, 2020
Details:
Pfenex received a positive opinion for PF708 (branded in Europe as Livogiva™) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Lead Product(s): Teriparatide
Therapeutic Area: Musculoskeletal Product Name: Livogiva
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 26, 2020
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