Asset profile

Omarigliptin · Marizev

Small molecule

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Reliablesignal

Evidence outlook · lead readout

NCT01755156 · Type 2 Diabetes Mellitus

The completed lead evidence has the design features that historically survive confirmatory trials: randomized, controlled, and adequately powered against a prespecified clinically accepted endpoint.

NCT01755156: This adequately powered (N=402), randomized, triple-blind, placebo-controlled trial used HbA1c - a hard, disease-defining measure for type 2 diabetes - as its primary efficacy endpoint. The primary comparison was statistically significant in favor of omarigliptin: HbA1c change from baseline was -0.54% with omarigliptin versus 0.00% with placebo (between-group difference -0.55%, 95% CI -0.75 to -0.34, p<0.001). The co-primary safety endpoints showed no statistically significant differences, but this does not detract from the efficacy result.

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Competitive landscape

79 competitors in this universe: 19 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 33 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Omarigliptin (Marizev): this drugPhase 3Small moleculeDPP-4
Alogliptin (Nesina)ApprovedSmall moleculeDPP-4
Linagliptin (Tradjenta)ApprovedSmall moleculeDPP-4
Saxagliptin (Onglyza)ApprovedSmall moleculeDPP-4
Sitagliptin (Januvia)ApprovedSmall moleculeDPP-4
Anagliptin (Suiny)Phase 3Small moleculeDPP-4
DBPR108Phase 3Small moleculeDPP-4
Evogliptin (Suganon)Phase 3Small moleculeDPP-4
Gemigliptin (Zemiglo)Phase 3Small moleculeDPP-4
GosogliptinPhase 3Small moleculeDPP-4
HenagliflozinPhase 3Small moleculeSodium-glucose cotransporter 2 (SGLT2), DPP-4
MP-513Phase 3Small moleculeDPP-4
SP2086Phase 3Small moleculeDPP-4
SYR-472Phase 3Small moleculeDPP-4
Teneligliptin (Tenelia)Phase 3Small moleculeDPP-4
Trelagliptin (Zafatek)Phase 3Small moleculeDPP-4

…and 64 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.

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 (11)
Phase 2 (1)
Phase 1 (3)
Phase 4 (2)
Early phase / not applicable (2)