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Details:
VX-121/VX-661/VX-561 (vanzacaftor/tezacaftor/deutivacaftor) is a combination of three CFTR modulators. It is being evaluated in phase 3 clinial trials for the treatment of Cystic Fibrosis.
Lead Product(s): Vanzacaftor,Tezacaftor,Deutivacaftor
Therapeutic Area: Genetic Disease Product Name: VX-121
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 February 05, 2024
Details:
Kaftrio (ivacaftor/tezacaftor/elexacaftor) is an oral medicine designed to binding to different sites on the CFTR protein, which is investigated for the treatment of cystic fibrosis in patients aged 2 years & above.
Lead Product(s): Ivacaftor,Tezacaftor,Elexacaftor
Therapeutic Area: Genetic Disease Product Name: Kaftrio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 24, 2023
Details:
Kaftrio (ivacaftor/tezacaftor/elexacaftor) is an oral medicine designed to binding to different sites on the CFTR protein, which is investigated for the treatment of cystic fibrosis in patients aged 2 years & above.
Lead Product(s): Ivacaftor,Tezacaftor,Elexacaftor
Therapeutic Area: Genetic Disease Product Name: Kaftrio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2023
Details:
Trikafta is a combination drug where elexacaftor and tezacaftor bind to different sites of CFTR and additionally facilitates the cellular processing and trafficking of mutated CFTR. Ivacaftor potentiates the channel open probability of the CFTR protein at the cell surface.
Lead Product(s): Elexacaftor,Tezacaftor,Ivacaftor
Therapeutic Area: Genetic Disease Product Name: Trikafta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2023
Details:
TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor), is prescription medicine for treatment of cystic fibrosis. Based on analysis through Week 144 of 192-week study, people receiving TRIKAFTA maintained improvement in lung function, respiratory symptom and CFTR function.
Lead Product(s): Elexacaftor,Tezacaftor,Ivacaftor
Therapeutic Area: Genetic Disease Product Name: Trikafta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2022
Details:
TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) real-world safety and effectiveness interim results show improved lung function and significant reductions in risk of pulmonary exacerbations, lung transplant and death for people with cystic fibrosis (CF).
Lead Product(s): Ivacaftor,Tezacaftor,Elexacaftor
Therapeutic Area: Genetic Disease Product Name: Trikafta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2022
Details:
TRIKAFTA is an oral medicine designed to increase quantity and function of CFTR protein at cell surface, is a prescription medicine used for treatment of cystic fibrosis in patients ages 6 years and older who have at least one copy of F508del mutation in CFTR gene.
Lead Product(s): Elexacaftor,Tezacaftor,Ivacaftor
Therapeutic Area: Genetic Disease Product Name: Trikafta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2022
Details:
TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) was approved by the Australian Therapeutic Goods Administration (TGA) in March 2021 based on the results of four global Phase 3 clinical trials, which included multiple Australian trial sites and patients.
Lead Product(s): Elexacaftor,Tezacaftor,Ivacaftor
Therapeutic Area: Genetic Disease Product Name: Trikafta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Australian Pharmaceutical Benefits Scheme
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 27, 2022
Details:
EC approval for KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor has shown clinical benefit for people with CF ages 12 and above. This medicine is also approved in the regulatory authorities of New Zealand and Switzerland, where it is known as TRIKAFTA.
Lead Product(s): Ivacaftor,Tezacaftor,Elexacaftor
Therapeutic Area: Genetic Disease Product Name: Kaftrio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 11, 2022
Details:
The agreement covers people with CF ages 12 years and older who have at least one copy of the F508del mutation, in the CFTR gene. KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor can be prescribed to eligible patients by treating physicians.
Lead Product(s): Ivacaftor,Tezacaftor,Elexacaftor
Therapeutic Area: Genetic Disease Product Name: Kaftrio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Spanish government
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 19, 2021
Details:
The clinical data for ivacaftor/tezacaftor/elexacaftor plus ivacaftor in people with CF ages 6 through 11 demonstrated improvements in lung function, sweat chloride and respiratory symptoms and a safety and tolerability profile.
Lead Product(s): Ivacaftor,Tezacaftor,Elexacaftor
Therapeutic Area: Genetic Disease Product Name: Kaftrio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 2021
Details:
96-week interim results of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) study show no loss of pulmonary function in people with at least one F508del allele, a first for any CFTR modulator. TRIKAFTA is prescription medicine used for treatment of cystic fibrosis.
Lead Product(s): Elexacaftor,Tezacaftor,Ivacaftor
Therapeutic Area: Genetic Disease Product Name: Trikafta
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 19, 2021
Details:
The combination of VX-121/tezacaftor/VX-561 was first identified as having potential for increased efficacy based on its ability to drive higher levels of chloride transport compared to TRIKAFTA (elexacaftor/tezacaftor/ivacaftor /ivacaftor) in human bronchial epithelial cells.
Lead Product(s): Vanzacaftor,Tezacaftor,Deutivacaftor
Therapeutic Area: Genetic Disease Product Name: VX-121
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2021
Details:
The reimbursement agreement enables broad access to KAFTRIO® for people with CF ages 12 years and older with one F508del mutation and one minimal function mutation.
Lead Product(s): Ivacaftor,Tezacaftor,Elexacaftor
Therapeutic Area: Genetic Disease Product Name: Kaftrio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: French Health Authorities for the cystic fibrosis
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 28, 2021
Details:
Italian patients ages 12 years and older with one F508del mutation and one minimal function mutation (F/MF) or two F508del mutations (F/F) in the CFTR gene will now have access to KAFTRIO in a combination regimen with ivacaftor.
Lead Product(s): Ivacaftor,Tezacaftor,Elexacaftor
Therapeutic Area: Genetic Disease Product Name: Kaftrio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: AIFA
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 25, 2021
Details:
Clinical experience with TRIKAFTA in patients 12 and older over the past 20 months has demonstrated this medicine has a meaningful and unprecedented clinical benefit for patients.
Lead Product(s): Elexacaftor,Tezacaftor,Ivacaftor
Therapeutic Area: Genetic Disease Product Name: Trikafta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2021
Details:
The label expansion means that Kaftrio in a combination regimen with ivacaftor is now available for the treatment of all CF patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Lead Product(s): Ivacaftor,Tezacaftor,Elexacaftor
Therapeutic Area: Genetic Disease Product Name: Kaftrio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2021
Details:
EMA CHMP adopted a positive opinion for the label extension of KAFTRIO in a combination with ivacaftor 150 mg tablets for the treatment of cystic fibrosis in all patients ages 12 years and older who have at least one F508del mutation in the CFTR gene.
Lead Product(s): Ivacaftor,Tezacaftor,Elexacaftor
Therapeutic Area: Genetic Disease Product Name: Kaftrio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 26, 2021
Details:
Australian Therapeutic Goods Administration (TGA) has approved the use of TRIKAFTA for people with cystic fibrosis ages 12 years and older who have at least one F508del mutation in the CFTR gene, the most common CF-causing mutation worldwide.
Lead Product(s): Ivacaftor,Tezacaftor,Elexacaftor
Therapeutic Area: Genetic Disease Product Name: Trikafta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2021
Details:
The primary endpoint of the study was safety and tolerability, and the results showed that TRIKAFTA was generally well tolerated and the safety data were consistent with those observed in previous Phase 3 studies.
Lead Product(s): Ivacaftor,Tezacaftor,Elexacaftor
Therapeutic Area: Genetic Disease Product Name: Trikafta
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 10, 2020
Details:
U.S. Food and Drug Administration (FDA) accepted three supplemental New Drug Applications (sNDAs) for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor).
Lead Product(s): Ivacaftor,Tezacaftor,Elexacaftor
Therapeutic Area: Genetic Disease Product Name: Trikafta
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 01, 2020
Details:
E.C has granted marketing authorization for KAFTRIO® in a combination regimen with ivacaftor to treat people with cystic fibrosis ages 12 years and older with one F508del mutation and one minimal function mutation (F/MF), or two F508del mutations (F/F) in the CFTR gene.
Lead Product(s): Elexacaftor,Tezacaftor,Ivacaftor
Therapeutic Area: Genetic Disease Product Name: Kaftrio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 21, 2020
Details:
The results of this study demonstrate that the triple combination provides significant additional benefit compared to existing CFTR modulator therapy for F/G and F/RF patients and supports the benefit of the medicine for patients with at least one F508del mutation.
Lead Product(s): Ivacaftor,Tezacaftor,Elexacaftor
Therapeutic Area: Genetic Disease Product Name: Trikafta
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 July 20, 2020
Details:
As part of the agreement with NHS England, Vertex has committed to submit ORKAMBI®, SYMKEVI® and KAFTRIO® to the National Institute for Health and Care Excellence (NICE) within an agreed upon timetable, allowing for a period of real-world data collection on the medicines.
Lead Product(s): Ivacaftor,Tezacaftor,Elexacaftor
Therapeutic Area: Genetic Disease Product Name: Kaftrio
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Vertex Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 30, 2020
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