Asset profile

HRS-7535

Small molecule

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Reliablesignal

Evidence outlook · lead readout

OUTSTAND-2 (NCT06589765) · Type 2 Diabetes

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

OUTSTAND-2 (NCT06589765): This was a randomized, double-blind, active-controlled trial (n=810) comparing HRS-7535 against dapagliflozin, both added to metformin. The prespecified non-inferiority comparison for the primary endpoint, HbA1c change at 32 weeks, was met at all three HRS-7535 doses, and the highest dose additionally showed a statistically significant advantage over dapagliflozin.

Caveat: this result is taken from a company announcement or a news report of one, not from the trial registry or a peer-reviewed publication. Treat the figures as the sponsor's own statement, not as independently verified evidence.

Also in development:Hypertension · Phase 3Obesity · Phase 3Heart Failure · Phase 2

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Competitive landscape

275 competitors in this universe: 49 direct rivals (same mechanism and indication), 1 same-class, 225 same-indication; 59 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
HRS-7535: this drugPhase 3Small moleculeGLP-1 receptor
Dulaglutide (Trulicity)ApprovedPeptideGLP-1 receptor
Liraglutide (Saxenda / Victoza)ApprovedPeptideGLP-1 receptor
Lixisenatide (Adlyxin / Lyxumia)ApprovedPeptideGLP-1 receptor
Orforglipron (Foundayo)ApprovedSmall moleculeGLP-1 receptor
Semaglutide (Wegovy / Ozempic / Rybelsus)ApprovedPeptideGLP-1 receptor
AleniglipronPhase 3Small moleculeGLP-1 receptor
AmycretinPhase 3PeptideGLP-1 receptor, Amylin receptor
ASC30Phase 3Small moleculeGLP-1 receptor
Cagrilintide / Semaglutide (CagriSema)Phase 3PeptideAmylin receptor, GLP-1 receptor
CJC-1134-PCPhase 3PeptideGLP-1 receptor
CX11Phase 3Small moleculeGLP-1 receptor
DA-302168SPhase 3Small moleculeGLP-1 receptor
EcnoglutidePhase 3PeptideGLP-1 receptor
EfpeglenatidePhase 3PeptideGLP-1 receptor
ElecoglipronPhase 3Small moleculeGLP-1 receptor

…and 260 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

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

Upcoming events

(4 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 2ObesityRecruiting
Est. primary completion 2026-12 · NCT06820099 · CT.gov ↗
What to watch
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2027 (2)
July 2027 (1)
Phase 2ObesityActive not recruiting
Est. primary completion 2027-07-07 · NCT07497880 · CT.gov ↗
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December 2027 (1)
Phase 3HypertensionRecruiting
Est. primary completion 2027-12 · NCT07528027 · CT.gov ↗
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2031 (1)
May 2031 (1)
Phase 3Chronic Kidney DiseaseNot yet recruiting
Est. primary completion 2031-05 · NCT07625774 · 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 (5)
Phase 2 (7)
Phase 1/2 (1)
Phase 1 (9)