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Details:
Xphozah (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), indicated for the treatment of pediatric Hyperphosphatemia.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: Xphozah
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 15, 2023
Details:
The financing will support the commercialization of company's two FDA approved products, Ibsrela (tenapanor), for irritable bowel syndrome with constipation, and Xphozah (tenapanor), indicated to reduce serum phosphorus in adults with chronic kidney disease.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: Xphozah
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: SLR Capital Partners
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing October 17, 2023
Details:
Xphozah (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), indicated for the treatment in adult with chronic kidney disease on dialysis.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: Xphozah
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 17, 2023
Details:
Phozevel (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the NHE3, indicated for the treatment improvement of hyperphosphatemia in adult patients with CKD on dialysis.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: Phozevel
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2023
Details:
The agreement provides Fosun Pharma the rights to develop and commercialize Ardelyx's lead product, tenapanor, in China for the treatment of patients with irritable bowel syndrome with constipation and for the treatment of hyperphosphatemia related to chronic kidney disease.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: Xphozah
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Fosun Pharmaceutical
Deal Size: $125.0 million Upfront Cash: $12.0 million
Deal Type: Licensing Agreement July 13, 2023
Details:
Xphozah (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), indicated for the treatment in adult with chronic kidney disease on dialysis.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: Xphozah
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 17, 2023
Details:
Xphozah (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), indicated for the treatment in adult with chronic kidney disease on dialysis.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: Xphozah
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 18, 2023
Details:
Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: Xphozah
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2022
Details:
XPHOZAH (tenapanor),is an investigational first-in-class phosphate absorption inhibitor, With its unique blocking MOA, XPHOZAH acts locally in gut, reducing phosphate absorption through paracellular pathway, primary pathway of phosphate absorption.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: Xphozah
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2022
Details:
Under the terms of the agreement, Ardelyx will execute a research plan to advance two of Ardelyx’s ongoing research programs focused on the identification and design of Tenapanor (xphozah), a phosphate absorption inhibitor, for the treatment of Hyperphosphatemia.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: Xphozah
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: $520.5 million Upfront Cash: $10.5 million
Deal Type: Licensing Agreement October 31, 2022
Details:
HealthCare Royalty Partners funding supports the ongoing launch of IBSRELA® (tenapanor) in the United States in exchange for future hyperphosphatemia royalty payments from Ardelyx Japanese collaboration partner.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: Ibsrela
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: HealthCare Royalty Partners
Deal Size: $20.0 million Upfront Cash: $10.0 million
Deal Type: Financing June 30, 2022
Details:
XPHOZAH (tenapanor), an investigational first-in-class phosphate absorption inhibitor. XPHOZAH, with its unique blocking mechanism of action, acts locally in the gut to inhibit the sodium hydrogen exchanger 3, reducing phosphate absorption through the paracellular pathway.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: Xphozah
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2022
Details:
IBSRELA (tenapanor) is a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium.
Lead Product(s): Tenapanor
Therapeutic Area: Gastroenterology Product Name: Ibsrela
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2022
Details:
XPHOZAH (tenapanor), an investigational first-in-class phosphate absorption inhibitor, with its unique blocking mechanism of action, acts locally in gut to inhibit NaOH exchanger, reducing phosphate absorption through paracellular pathway.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: Xphozah
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 25, 2022
Details:
The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats, decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor.
Lead Product(s): Tenapanor
Therapeutic Area: Gastroenterology Product Name: Ibsrela
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2021
Details:
Tenapanor, discovered and developed by Ardelyx, has a unique mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: RDX5791
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2021
Details:
Tenapanor would enable a substantially larger fraction of patients to reach target serum phosphorus concentrations and would yield significant clinical benefit to this vulnerable population.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: Ibsrela
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 29, 2021
Details:
Five posters continue to support the foundational role tenapanorcould play in the treatment of hyperphosphatemia. Tenapanor is a phosphate absorption inhibitor currently under review by the FDA for the control of serum phosphorus in adult patients with CKD on dialysis.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: RDX5791
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
Comprehensive datasets demonstrate tenapanor's ability to control serum phosphorous in patients with chronic kidney disease (CKD) on dialysis.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: RDX5791
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2020
Details:
The NDA is supported by three successful Phase 3 trials that evaluated the use of tenapanor, which included two monotherapy trials.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: RDX5791
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2020
Details:
The submission is supported by three successful Phase 3 trials involving over 1,000 patients that evaluated the use of tenapanor for Hyperphosphatemia, a condition which affects approximately 85% of CKD Patients on Dialysis.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: RDX5791
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2020
Details:
Foundational use of tenapanor as monotherapy or with sevelamer enabled up to 47.4% of patients to achieve normal serum phosphorus levels (<4.6 mg/dL), a 58% improvement over current standard of care, showed the data analysis from NORMALIZE Phase 4 Study.
Lead Product(s): Tenapanor,Sevelamer Hydrochloride
Therapeutic Area: Nephrology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
KHK7791 (Tenapanor) effect of decreasing pill burden of phosphate binders, which is the outcome of a phase 2 study of tenapanor for hemodialysis patients with hyperphosphatemia in Japan, was presented in a poster session virtually at ERA-EDTA 2020 annual meeting.
Lead Product(s): Tenapanor
Therapeutic Area: Nephrology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ardelyx
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2020
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