Asset profile

Pralsetinib

Small molecule

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Acceleratedaccelerated approval

Evidence outlook

Accelerated approval: Non-Small Cell Lung Cancer (label: metastatic RET fusion-positive NSCLC)

Accelerated approval is granted on surrogate endpoints; confirmatory clinical benefit is being verified in ongoing trials. Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.

track record: Partial signal

How the evidence outlook works ↗

Competitive landscape

65 competitors in this universe: 5 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Pralsetinib: this drugApprovedSmall moleculeRET
SelpercatinibApprovedSmall moleculeRET
EP0031Phase 1/2Small moleculeRET
HEC169096Phase 1/2Small moleculeRET
KL590586Phase 1/2Small moleculeRET
TAS0953Phase 1/2Small moleculeRET
Afatinib (Gilotrif)ApprovedSmall moleculeEGFR/HER1, HER2, HER4
Alectinib (Alecensa)ApprovedSmall moleculeALK
Alymsys (bevacizumab-Maly)ApprovedMonoclonal antibodyVEGF-A
AmivantamabApprovedMultispecific antibodyEGFR x c-MET
AtezolizumabApprovedMonoclonal antibodyPD-L1
BAT1706 (Avzivi)ApprovedMonoclonal antibodyVEGF-A
BAY2927088 (Hyrnuo)ApprovedSmall moleculeHER2 (ERBB2) exon 20 insertions and point mutations; also mutant-selective EGFR
BevacizumabApprovedMonoclonal antibodyVEGF-A, Vascular Endothelial Growth Factor Inhibitor
Bevacizumab-Awwb (MVASI)ApprovedMonoclonal antibodyVEGF-A
BinimetinibApprovedSmall moleculeMEK1/2

…and 50 more. Research shows the complete landscape.

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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

(7 total)

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

2026 (2)
November 2026 (1)
Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2026-11-30 · NCT04302025 · CT.gov ↗
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December 2026 (1)
Phase 4Advanced Thyroid Cancer Patients Who Received Target TherapyRecruiting
Est. primary completion 2026-12-31 · NCT06195228 · CT.gov ↗
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2027 (4)
July 2027 (1)
Phase 4Non-Small Cell Lung CancerRecruiting
Est. primary completion 2027-07-30 · NCT07704658 · CT.gov ↗
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November 2027 (1)
Phase 2Lung Cancer Stage III, MutationRecruiting
Est. primary completion 2027-11-01 · NCT06563999 · CT.gov ↗
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December 2027 (2)
Phase 4Thyroid NeoplasmsNot yet recruiting
Est. primary completion 2027-12-31 · NCT07010393 · CT.gov ↗
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Early phase / not applicableNon-Small Cell Lung CancerNot yet recruiting
Est. primary completion 2027-12-31 · NCT07418879 · CT.gov ↗
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2032 (1)
September 2032 (1)
Phase 2Solid TumorsActive not recruiting
Est. primary completion 2032-09-25 · NCT04589845 · 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 (2)
Phase 2 (6)
Phase 1/2 (1)
Phase 4 (3)
Early phase / not applicable (1)