Asset profile

Dorzagliatin · Huatangning

Small molecule

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Phase 3underway

Evidence outlook · registrational

Type 2 Diabetes: registrational readout pending

Entered Phase 3 on partial signal mid-stage evidence. The registry's posted readout date (2025-07-29) has passed without a status update. Check News for topline announcements.

NCT04531631: The study used randomized, triple-blind, placebo-controlled crossover treatment, but enrolled only 18 participants and measured a mechanistic insulin-response biomarker rather than a clinical diabetes outcome. Because the registry provides no primary-endpoint results, it is not possible to determine whether the comparison met its prespecified endpoint.

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Competitive landscape

65 competitors in this universe: 5 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
Dorzagliatin (Huatangning): this drugPhase 3Small moleculeGlucokinase
PB-201Phase 3Small moleculeGlucokinase
SY-004Phase 2Small moleculeGlucokinase
GK1-399 (formerly TTP399)Phase 1/2Small moleculeGlucokinase
Globalagliatin HydrochloridePhase 1Small moleculeGlucokinase
HMS1005Phase 1Small moleculeGlucokinase
AfrezzaApprovedPeptideInsulin receptor (basal), Insulin
Alogliptin (Nesina)ApprovedSmall moleculeDPP-4
Bexagliflozin (Brenzavvy)ApprovedSmall moleculeSGLT2
Canagliflozin (Invokana)ApprovedSmall moleculeSGLT2
Dapagliflozin (Farxiga / Forxiga)ApprovedSmall moleculeSGLT2
Dulaglutide (Trulicity)ApprovedPeptideGLP-1 receptor
Empagliflozin (Jardiance)ApprovedSmall moleculeSGLT2
Ertugliflozin (Steglatro)ApprovedSmall moleculeSGLT2
Glipizide (Glucotrol)ApprovedSmall moleculeSulfonylurea receptor (SUR1)
Glyburide (Diabeta / Micronase)ApprovedSmall moleculeSulfonylurea receptor (SUR1)

…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

(3 total)

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

2026 (1)
December 2026 (1)
Phase 2Diabetes Mellitus, Monogenic DiabetesRecruiting
Est. primary completion 2026-12-31 · NCT06976658 · CT.gov ↗
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2027 (1)
July 2027 (1)
Phase 1Pancreatic Insufficiency, Cystic Fibrosis-related DiabetesRecruiting
Est. primary completion 2027-07 · NCT06995651 · CT.gov ↗
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2029 (1)
March 2029 (1)
Early phase / not applicableType 2 DiabetesNot yet recruiting
Est. primary completion 2029-03-01 · NCT07786571 · 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 (3)
Phase 2 (3)
Phase 1/2 (1)
Phase 1 (12)
Phase 4 (1)
Early phase / not applicable (3)