Asset profile

Ivacaftor · Kalydeco

Small molecule

Approved / Phase 4Mechanism not established
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Approvedregulatory verdict

Evidence outlook

Approved: Cystic Fibrosis

Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.

track record: Reliable signal

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Competitive landscape

7 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 7 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Ivacaftor (Kalydeco): this drugApprovedSmall molecule—
Elexacaftor / Tezacaftor / Ivacaftor (Trikafta)ApprovedSmall molecule—
LumacaftorApprovedSmall moleculeCFTR
Tezacaftor / Ivacaftor (Symdeko)ApprovedSmall molecule—
Vanzacaftor / Tezacaftor / Deutivacaftor (Alyftrek)ApprovedSmall molecule—
VX-522Phase 1/2RNA / oligonucleotide—
KB407Phase 1Gene therapy / editing—
VX-828Phase 1Small molecule—
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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(8 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (1)
November 2026 (1)
Phase 2Cystic FibrosisActive not recruiting
Est. primary completion 2026-11 · NCT06237335 · CT.gov ↗
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2027 (4)
February 2027 (1)
Early phase / not applicableCystic FibrosisRecruiting
Est. primary completion 2027-02-02 · NCT07314229 · CT.gov ↗
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April 2027 (2)
Phase 1Chronic Rhinosinusitis (Diagnosis)Recruiting
Est. primary completion 2027-04 · NCT03439865 · CT.gov ↗
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Phase 3Cystic FibrosisActive not recruiting
Est. primary completion 2027-04-06 · NCT05331183 · CT.gov ↗
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November 2027 (1)
Early phase / not applicableCystic FibrosisRecruiting
Est. primary completion 2027-11 · NCT06457451 · CT.gov ↗
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2028 (1)
April 2028 (1)
Phase 4Cystic FibrosisNot yet recruiting
Est. primary completion 2028-04 · NCT07809867 · CT.gov ↗
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2029 (1)
July 2029 (1)
Phase 4Cystic FibrosisActive not recruiting
Est. primary completion 2029-07-01 · NCT04602468 · CT.gov ↗
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2030 (1)
December 2030 (1)
Phase 4Cystic FibrosisRecruiting
Est. primary completion 2030-12 · NCT07148739 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (38)
Phase 2 (22)
Phase 1 (17)
Phase 4 (9)
Early phase / not applicable (8)
Used as active comparator (2)
Appears in other studies (2)