Asset profile

Insulin Efsitora Alfa

Protein / enzyme therapeutic

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Evidence outlook · lead readout

QWINT-1 (NCT05662332) · Type 2 Diabetes, T2D

The completed lead evidence is positive, with design limits that temper confidence; the rationale below says which.

QWINT-1 (NCT05662332): The trial was randomized and adequately sized, comparing efsitora with active-control insulin glargine in 795 participants, and its primary HbA1c endpoint met the prespecified noninferiority margin. However, the registry lists no participant or investigator masking, with only the sponsor blinded, so it does not have the fully double-blind design needed for the highest evidence grade.

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Competitive landscape

80 competitors in this universe: 19 direct rivals (same mechanism and indication), 1 same-class, 60 same-indication; 33 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Insulin Efsitora Alfa: this drugPhase 3Protein / enzyme therapeuticInsulin receptor (basal)
AfrezzaApprovedPeptideInsulin receptor (basal), Insulin
Insulin Degludec (Tresiba)ApprovedPeptideInsulin receptor (basal)
Insulin Detemir (Levemir)ApprovedPeptideInsulin receptor (basal)
Insulin Glargine (Lantus / Toujeo)ApprovedPeptideInsulin receptor (basal)
Insulin Glulisine (Apidra)ApprovedPeptideInsulin receptor (basal)
Insulin Icodec (Awiqli)ApprovedPeptideInsulin receptor (basal)
Insulin Lispro (Humalog)ApprovedPeptideInsulin receptor (basal)
LY2963016 (Basaglar)ApprovedPeptideInsulin receptor (basal)
LY900014 (Lyumjev)ApprovedPeptideInsulin receptor (basal)
SAR341402ApprovedPeptideInsulin receptor (basal)
GZR33Phase 3PeptideInsulin receptor (basal)
IcoSema (Kyinsu)Phase 3PeptideInsulin receptor (basal), GLP-1 receptor
INS068Phase 3PeptideInsulin receptor (basal)
ORMD-0801Phase 3PeptideInsulin receptor (basal)
THDB0206Phase 3PeptideInsulin receptor (basal)

…and 65 more. Research shows the complete landscape.

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Unlock the full comparison

Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Compare head-to-head

13 further head-to-head pairs are tracked; the rosters on each shared mechanism and indication page list every rival in the race.

Upcoming events

No upcoming readouts on record for this asset.

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 (5)
Phase 2 (3)
Phase 1 (11)