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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 children With cystic fibrosis ages 2 through 5.


Lead Product(s): Elexacaftor,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 September 15, 2023

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Orkambi is a combination of lumacaftor which improves the conformational stability of F508del-CFTR and ivacaftor, a CFTR potentiator. It is being used for cystic fibrosis in patients aged 1 year and older who have two copies of the F508del mutation in CFTR gene.


Lead Product(s): Lumacaftor,Ivacaftor

Therapeutic Area: Genetic Disease Product Name: Orkambi

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 05, 2023

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ELX-02 exaluren) is a small molecule drug candidate designed to restore production of full-length functional proteins. It is being developed for the treatment of CF patients with nonsense mutations.


Lead Product(s): Exaluren Sulfate,Ivacaftor

Therapeutic Area: Genetic Disease Product Name: ELX-02

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 June 14, 2023

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Kalydeco (ivacaftor) is a potentiator of the CFTR protein. The CFTR protein is a chloride channel present at the surface of epithelial cells in multiple organs. it has received USFDA approval to treat eligible infants with CF ages 1 month and older.


Lead Product(s): Ivacaftor

Therapeutic Area: Genetic Disease Product Name: Kalydeco

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 03, 2023

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Orkambi is a combination of lumacaftor which improves the conformational stability of F508del-CFTR and ivacaftor is a CFTR potentiator. It is being used for cystic fibrosis in patients aged 1 year and older who have two copies of the F508del mutation in CFTR gene.


Lead Product(s): Lumacaftor,Ivacaftor

Therapeutic Area: Genetic Disease Product Name: Orkambi

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 27, 2023

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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

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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

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Evidence of activity for ELX-02 was observed, as patients with higher baseline sweat chloride levels demonstrated increased responses as indicated by SCC (p=0.00013 at Day 35).


Lead Product(s): ELX-02,Ivacaftor

Therapeutic Area: Genetic Disease Product Name: ELX-02

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 September 14, 2022

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Details:

ORKAMBI® (lumacaftor/ivacaftor) is an oral medicine that is a combination of lumacaftor and ivacaftor. Lumacaftor is designed to increase the amount of mature protein at the cell surface by targeting the processing and trafficking defect of the F508del-CFTR protein.


Lead Product(s): Lumacaftor,Ivacaftor

Therapeutic Area: Genetic Disease Product Name: Orkambi

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 02, 2022

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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

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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

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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

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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

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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

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In preclinical studies, Class 1 CF patient organoids had a 2- to 3-fold higher swelling response with a combination of ELX-02 and Kalydeco than with ELX-02 as a monotherapy. Topline results are expected by the end of the first half of 2022.


Lead Product(s): ELX-02,Ivacaftor

Therapeutic Area: Genetic Disease Product Name: ELX-02

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 November 17, 2021

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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

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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

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PrKalydeco (ivacaftor), a CFTR potentiator used for the treatment of cystic fibrosis (CF) in patients from 4 months to 18 years of age.


Lead Product(s): Ivacaftor

Therapeutic Area: Genetic Disease Product Name: Kalydeco

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 24, 2021

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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

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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

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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

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Details:

The Phase 2 clinical program now includes a fifth treatment arm to evaluate safety of ELX-02 in combination with Kalydeco, an FDA-approved CFTR potentiator for the treatment of cystic fibrosis in patients who have at least one mutation in their CF gene amenable to ivacaftor.


Lead Product(s): Eukaroyotic ribosomal selective glycoside,Ivacaftor

Therapeutic Area: Genetic Disease Product Name: ELX-02

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 April 29, 2021

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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

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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

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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

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Details:

KALYDECO® (ivacaftor) will be now available to additional eligible patients in Germany and will be available shortly in countries that have entered into innovative long-term reimbursement agreements with Vertex, including the UK, Denmark and the Republic of Ireland.


Lead Product(s): Ivacaftor

Therapeutic Area: Genetic Disease Product Name: Kalydeco

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 05, 2020

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Funding will support the CF Foundation’s work to fund research and drug development and advance high-quality, specialized CF care. KALYDECO® (ivacaftor) as First and Only CFTR Modulator, indicate to treat Eligible Infants With CF as Early as Four Months of Age.


Lead Product(s): Ivacaftor

Therapeutic Area: Genetic Disease Product Name: Kalydeco

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Royalty Pharma

Deal Size: $650.0 million Upfront Cash: $575.0 million

Deal Type: Acquisition November 02, 2020

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Details:

Safety data from a cohort of the Phase 3 ARRIVAL study support treatment with KALYDECO in children ages four to <6 months with eligible mutations.


Lead Product(s): Ivacaftor

Therapeutic Area: Genetic Disease Product Name: Kalydeco

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, 2020

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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

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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

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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

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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

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  • Deals

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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Details:

Agreement enables the possibility of rapid patient access to future triple combination regimen (elexacaftor/tezacaftor/ivacaftor and ivacaftor) once approved in Switzerland .


Lead Product(s): Lumacaftor,Ivacaftor

Therapeutic Area: Genetic Disease Product Name: Undisclosed

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: FSIO

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement April 21, 2020

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