ALYFTREK (deutivacaftor)
ALYFTREK is a next-generation CFTR modulator combination (vanzacaftor, tezacaftor, deutivacaftor) for cystic fibrosis in patients aged 6 years and older with at least one F508del mutation. Offers once-daily dosing.
How ALYFTREK Works
This combination therapy increases the quantity and function of the CFTR protein at the cell surface to improve chloride transport. Vanzacaftor and tezacaftor facilitate the cellular processing and trafficking of mutant CFTR proteins, which increases the amount of protein that reaches the cell membrane. Deutivacaftor acts as a potentiator by increasing the gating, or the probability that the CFTR protein channels remain open at the cell surface. The combined effect of these three components addresses the underlying cellular defects associated with specific CFTR mutations.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-12-20
- Patent Cliff
- 2043
- Revenue
- $380.1M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
ALYFTREK Approval History
What ALYFTREK Treats
1 indicationsALYFTREK is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cystic Fibrosis
ALYFTREK Boxed Warning
DRUG-INDUCED LIVER INJURY AND LIVER FAILURE Elevated transaminases have been observed in patients treated with ALYFTREK. Cases of serious and potentially fatal drug-induced liver injury and liver failure were reported in patients who were taking a fixed-dose combination drug containing elexacaftor, tezacaftor, and ivacaftor, which contains the same or similar active ingredients as ALYFTREK. Liver injury has been reported within the first month of therapy and up to 15 months following initiation ...
WARNING: DRUG-INDUCED LIVER INJURY AND LIVER FAILURE Elevated transaminases have been observed in patients treated with ALYFTREK. Cases of serious and potentially fatal drug-induced liver injury and liver failure were reported in patients who were taking a fixed-dose combination drug containing elexacaftor, tezacaftor, and ivacaftor, which contains the same or similar active ingredients as ALYFTREK. Liver injury has been reported within the first month of therapy and up to 15 months following initiation of elexacaftor/tezacaftor/ivacaftor [see Warnings and Precautions (5.1) and Adverse Reactions (6) ]. Assess liver function tests (ALT, AST, alkaline phosphatase, and bilirubin) in all patients prior to initiating ALYFTREK, 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 elevated liver function tests at baseline [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) , Adverse Reactions (6) , and Use in Specific Populations (8.7) ] . Interrupt ALYFTREK 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 ALYFTREK [see Warnings and Precautions (5.1) ] . ALYFTREK should not be used in patients with severe hepatic impairment (Child-Pugh Class C). ALYFTREK is not recommended in patients with moderate hepatic impairment (Child-Pugh Class B) and should only be considered when there is a clear medical need, and the benefit outweighs the risk. If used, monitor patients closely [see Dosage and Administration (2.4) , Warnings and Precautions (5.1) , Adverse Reactions (6) , Use in Speci
ALYFTREK Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ALYFTREK
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06154447 | VX23-828-001 | Ph 1 | recruiting | Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis |
| NCT03029455 | VX16-659-001 2016-003048-35 | Ph 1 | completed | A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic Fibrosis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ALYFTREK FDA Label Details
Indications & Usage
FDA Label (PDF)ALYFTREK is indicated for the treatment of Cystic Fibrosis.
WARNING: DRUG-INDUCED LIVER INJURY AND LIVER FAILURE Elevated transaminases have been observed in patients treated with ALYFTREK. Cases of serious and potentially fatal drug-induced liver injury and liver failure were reported in patients who were taking a fixed-dose combination drug containing elex...
ALYFTREK Patents & Exclusivity
Patents (33 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ALYFTREK
Revenue Insights
- • Q4-2025: $380.1M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2043
- • 188 active patents
Trial Analysis
- • 3 total trials
- • Stage: Growth
Competitive Landscape
- • 12 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment