PharmaRadar360

PharmaRadar360

RespiratoryDrug intelligence

Trikafta

Elexacaftor/Tezacaftor/Ivacaftor

CFTR correctors (elexacaftor, tezacaftor) with a CFTR potentiator (ivacaftor). Developed by Vertex. Clinical, regulatory, and source evidence are connected below.

Company
Vertex
Target / MOA
CFTR
Aliases
Trikafta 路 Kaftrio
Signals
20
Clinical trials
12
Approvals
0
Evidence sources
20

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age

Phase 3 路 COMPLETED 路 Vertex Pharmaceuticals Incorporated

clinical trialClinicalTrials.gov

Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis

Phase 4 路 RECRUITING 路 Istituto Giannina Gaslini

clinical trialClinicalTrials.gov

Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del

Phase 3 路 ACTIVE_NOT_RECRUITING 路 Vertex Pharmaceuticals Incorporated

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.

United States (FDA label)

Trikafta 路 NDA212273, NDA217660 路 label version 23, effective Jun 22, 2026 路 DailyMed

Label section 1

1 INDICATIONS AND USAGE TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients aged 2 years and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene that is either responsive based on clinical and/or in vitro data (see Table 6 ) or results in production of CFTR protein [see Clinical Pharmacology (12.1) ] . If the patient's genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein.

European Union (EMA)

Kaftrio 路 EMEA/H/C/005269 路 Authorised, authorised Aug 21, 2020 (Commission decision C(2020) 5845) 路 EPAR

Kaftrio tablets are indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Kaftrio granules are indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in paediatric patients aged 2 to less than 6 years who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.

United States

NDA212273 路 VERTEX PHARMS INC 路 first approved Oct 21, 2019

4 efficacy supplements approved

NDA217660 路 VERTEX PHARMS INC 路 first approved Apr 26, 2023

2 efficacy supplements approved

European Union

  • Kaftrio: Authorised since Aug 21, 2020

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.

NDA212273 (Orange Book)

29 listed patents, latest expiry Jul 17, 2038
  • US 8410274 路 expires Dec 28, 2026 路 drug product
  • US 8754224 路 expires Dec 28, 2026 路 drug substance, drug product
  • US 9670163 路 expires Dec 28, 2026 路 drug product, U-4078, U-3031, U-3155, U-4477
  • US 9931334 路 expires Dec 28, 2026 路 drug product, U-4078, U-3031, U-3155, U-4479
  • US 10022352 路 expires Apr 9, 2027 路 drug product, U-2651, U-3156
  • US 10239867 路 expires Apr 9, 2027 路 drug substance, drug product, U-3158, U-4056, U-3033, U-4475
  • US 11639347 路 expires Apr 9, 2027 路 drug substance, drug product, U-3587, U-4056, U-4475
  • US 9974781 路 expires Apr 9, 2027 路 drug product, U-3028, U-3144, U-4073, U-4475
  • US 7645789 路 expires May 1, 2027 路 drug substance, drug product
  • US 8598181 路 expires May 1, 2027 路 U-3028, U-3144, U-4056, U-4475
  • US 8623905 路 expires May 1, 2027 路 drug substance, drug product
  • US 7495103 路 expires May 20, 2027 路 drug substance, drug product
  • US 7776905 路 expires Jun 3, 2027 路 drug substance, drug product
  • US 8324242 路 expires Aug 5, 2027 路 U-4073, U-3028, U-3144, U-4475
  • US 8415387 路 expires Nov 12, 2027 路 U-4073, U-3028, U-3144, U-4475
  • US 10646481 路 expires Aug 13, 2029 路 drug product
  • US 11564916 路 expires Aug 13, 2029 路 U-3525, U-4063, U-4491
  • US 12458635 路 expires Aug 13, 2029 路 drug product, U-4330, U-4486
  • US 10081621 路 expires Mar 25, 2031 路 drug product, U-4075, U-3032, U-3157, U-4480
  • US 11578062 路 expires Mar 25, 2031 路 drug product, U-3544, U-4054, U-4490
  • US RE50453 路 expires Jul 10, 2031 路 drug substance, drug product
  • US 9012496 路 expires Jul 15, 2033 路 U-2649, U-3154
  • US 10758534 路 expires Oct 6, 2035 路 drug substance, drug product, U-3144, U-4073, U-3028, U-4475
  • US 11426407 路 expires Oct 6, 2035 路 drug substance, drug product, U-3425, U-4070, U-4475
  • US 10793547 路 expires Dec 8, 2037 路 drug substance, drug product, U-4073, U-3144, U-3028, U-4475
  • US 11179367 路 expires Dec 8, 2037 路 drug product, U-3253, U-4071, U-4487
  • US 11453655 路 expires Dec 8, 2037 路 drug substance, drug product
  • US 11517564 路 expires Dec 8, 2037 路 drug product, U-3498, U-4067, U-4069, U-4475
  • US 12350262 路 expires Jul 17, 2038 路 U-4221, U-4222, U-4475

Exclusivity: ODE-275 until Oct 21, 2026 (some products only: TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG); ODE* until Oct 21, 2026 (some products only: TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG); M-313 until Dec 20, 2027; ODE-323 until Dec 21, 2027 (some products only: TRIKAFTA (COPACKAGED) 100MG,75MG,50MG; 150MG); ODE* until Dec 21, 2027 (some products only: TRIKAFTA (COPACKAGED) 50MG,37.5MG,25MG; 75MG); ODE-357 until Jun 8, 2028; ODE-512 until Dec 20, 2031; ODE-543 until Mar 27, 2033 路 Orange Book entry

NDA217660 (Orange Book)

33 listed patents, latest expiry Jul 17, 2038
  • US 8410274 路 expires Dec 28, 2026 路 drug product
  • US 8754224 路 expires Dec 28, 2026 路 drug substance, drug product
  • US 9670163 路 expires Dec 28, 2026 路 drug product, U-4068, U-3591, U-4478
  • US 9931334 路 expires Dec 28, 2026 路 drug product, U-4068, U-3591, U-4478
  • US 10022352 路 expires Apr 9, 2027 路 drug product, U-3596
  • US 10239867 路 expires Apr 9, 2027 路 drug substance, drug product, U-3590, U-4053, U-4476
  • US 11639347 路 expires Apr 9, 2027 路 drug substance, drug product, U-3583, U-4053, U-4476
  • US 9974781 路 expires Apr 9, 2027 路 drug product, U-4066, U-3589, U-4476
  • US 7645789 路 expires May 1, 2027 路 drug substance, drug product
  • US 8598181 路 expires May 1, 2027 路 U-4066, U-3589, U-4476
  • US 8623905 路 expires May 1, 2027 路 drug substance, drug product
  • US 7495103 路 expires May 20, 2027 路 drug substance, drug product
  • US 7776905 路 expires Jun 3, 2027 路 drug substance, drug product
  • US 8324242 路 expires Aug 5, 2027 路 U-4066, U-3589, U-4476
  • US 8415387 路 expires Nov 12, 2027 路 U-3589, U-4066, U-4476
  • US 10646481 路 expires Aug 13, 2029 路 drug product
  • US 11564916 路 expires Aug 13, 2029 路 U-3585, U-4055, U-4485
  • US 12458635 路 expires Aug 13, 2029 路 drug product, U-4333, U-4493
  • US 10081621 路 expires Mar 25, 2031 路 drug product, U-4065, U-3600, U-4481
  • US 11578062 路 expires Mar 25, 2031 路 drug product, U-3584, U-4054, U-4488
  • US RE50453 路 expires Jul 10, 2031 路 drug substance, drug product
  • US 10272046 路 expires Feb 27, 2033 路 drug product, U-3599, U-4062, U-4482
  • US 11147770 路 expires Feb 27, 2033 路 drug product, U-3598, U-4060, U-4483
  • US 11752106 路 expires Feb 27, 2033 路 drug product, U-3696, U-4052, U-4489
  • US 12214083 路 expires Feb 27, 2033 路 drug product, U-4141, U-4492
  • US 8883206 路 expires Feb 27, 2033 路 drug product
  • US 10758534 路 expires Oct 6, 2035 路 drug substance, drug product, U-3589, U-4066, U-4476
  • US 11426407 路 expires Oct 6, 2035 路 drug substance, drug product, U-3595, U-4058, U-4476
  • US 10793547 路 expires Dec 8, 2037 路 drug substance, drug product, U-3588, U-4066, U-4476
  • US 11179367 路 expires Dec 8, 2037 路 drug product, U-3597, U-4059, U-4484
  • US 11453655 路 expires Dec 8, 2037 路 drug substance, drug product
  • US 11517564 路 expires Dec 8, 2037 路 drug product, U-3586, U-4057, U-4476
  • US 12350262 路 expires Jul 17, 2038 路 U-4220, U-4476 路 listed for some products only: TRIKAFTA (COPACKAGED) 100MG, 75MG, 50MG;75MG

Exclusivity: M-313 until Dec 20, 2027 (some products only: TRIKAFTA (COPACKAGED) 80MG, 60MG, 40MG;59.5MG); ODE-433 until Apr 26, 2030; ODE-512 until Dec 20, 2031; ODE-543 until Mar 27, 2033 路 Orange Book entry

Generics and biosimilars

The Orange Book lists no approved generic (ANDA).

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.

Boxed warning

Trikafta label

WARNING: DRUG-INDUCED LIVER INJURY AND LIVER FAILURE TRIKAFTA can cause serious and potentially fatal drug-induced liver injury. Cases of liver failure leading to transplantation and death have been reported in patients with and without a history of liver disease taking TRIKAFTA, in both clinical trials and the postmarketing setting [see Adverse Reactions (6) ]. Liver injury has been reported within the first month of therapy and up to 15 months following initiation of TRIKAFTA . Assess liver function tests (ALT, AST, alkaline phosphatase, and bilirubin) in all patients prior to initiating TRIKAFTA. Assess liver function tests every month during the first 6 months of treatment, then every 3 months for the next 12 months, then at least annually thereafter. Consider more frequent monitoring for patients with a history of liver disease or liver function test elevations at baseline [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) , Adverse Reactions (6) and Use in Specific Populations (8.7) ] . Interrupt TRIKAFTA for significant elevations in liver function tests or in the event of signs or symptoms of liver injury. Consider referral to a hepatologist. Follow patients closely with clinical and laboratory monitoring until abnormalities resolve. If abnormalities resolve, resume treatment only if the benefit is expected to outweigh the risk. Closer monitoring is advised after resuming TRIKAFTA [see Warnings and Precautions (5.1) ] . TRIKAFTA should not be used in patients with severe hepatic impairment (Child-Pugh Class C). TRIKAFTA is not recommended in patients with moderate hepatic impairment (Child-Pugh Class B). If used, use with caution at a reduced dosage and monitor patients closely [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) , Adverse Reactions (6) , Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ] .

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies 路 12 linked records.

Phase 3COMPLETEDNCT05882357

Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age

Vertex Pharmaceuticals Incorporated 路 Updated Oct 15, 2026

Phase 4RECRUITINGNCT07809867

Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis

Istituto Giannina Gaslini 路 Updated Oct 14, 2026

Phase 3ACTIVE NOT RECRUITINGNCT05331183

Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del

Vertex Pharmaceuticals Incorporated 路 Updated Oct 9, 2026

N/ACOMPLETEDNCT07841353

Impact of Trikafta on P2X7R and Clinical Outcomes in Cystic Fibrosis

Ain Shams University 路 Updated Oct 1, 2026

N/ARECRUITINGNCT06191640

Sinus Disease in Young Children With Cystic Fibrosis

University of California, Los Angeles 路 Updated Sep 10, 2026

Phase 4ACTIVE NOT RECRUITINGNCT04602468

Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER)

Royal College of Surgeons, Ireland 路 Updated Sep 9, 2026

Regulatory timeline

Approvals and agency activity

Verified regulatory records in reverse chronological order.

No regulatory event is available in this snapshot.

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial 路 Latest Oct 19, 202620
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.