All therapiesEvidence snapshot 2026-09-13
Weight & glucose

HRS-7535 (KAI-7535)

An oral small molecule that activates GLP-1 receptors.

At a glance

Selected evidence in this atlas
Studied use & population

Chinese adults with overweight or obesity without diabetes

Study context
Approval & development

China obesity phase 3 positive; global phase 2 ongoing with 2027 data planned.

Status & indications
Selected efficacy evidence

9.8% reported weight loss · 2.4% loss with placebo · 44 weeks

HARBOR-1 / HRS-7535-303 · Phase 3 · sponsor · 180 mg once daily · Regardless of stopping treatment

Evidence & limitations
Important safety context

Most reported adverse events were mild or moderate gastrointestinal events.

Safety context
Next milestone

A next milestone is not summarized for this therapy.

Milestone details

Study results apply to their own population, dose and analysis. They do not establish a ranking between therapies.

Evidence in the atlas

2 results

Each result belongs to its own study population, dose and analysis. Open a result for its chart, comparator, safety findings and limitations.

Weight loss

HARBOR-1 / HRS-7535-303

9.8% reported weight loss · 2.4% loss with placebo · 44 weeks

180 mg once daily

Chinese adults with overweight or obesity without diabetes

Primary week 44 analysis including discontinuation and other obesity therapies. China obesity phase 3 positive; global phase 2 ongoing with 2027 data planned.

Safety context

Most reported adverse events were mild or moderate gastrointestinal events.

Limitations: Week 50 11.1% is ad hoc efficacy analysis, not primary TP. Sponsor topline.

Glucose control

Metformin add-on study

1.64 percentage-point HbA1c decrease · 0.25 pp decrease with Placebo · 16 weeks

90 mg daily after escalation

Adults with type 2 diabetes

Adjusted repeated-measures estimate from the published phase 2 trial.

Safety context

Across active arms, adverse events occurred in 71.8–84.6%, mainly mild/moderate gastrointestinal events. Nine participants had level 1 hypoglycemia; no level 2 or 3 events were reported.

Limitations: Highest dose shown; the 60 mg arm had a numerically larger decrease (1.82 pp). Dose response was not monotonic.

Biology & identity

Status in this atlas: China obesity phase 3 positive; global phase 2 ongoing with 2027 data planned.

Hormone activity

An oral small molecule that activates GLP-1 receptors.

No approved trade name verified as of September 13, 2026; the compound name and development codes are not trade names.

Hengrui Pharma · Originator and Greater-China developer.; Kailera Therapeutics · Exclusive development and commercialization licensee outside China, Hong Kong, Macau and Taiwan.

Uses, doses and availability depend on the formulation, indication and country. Study doses below describe research; they are not prescribing instructions.

The molecule

2D chemical structure

HRS-7535 (safiglipron) · 2D chemical structure

Chemical connectivity and stereochemistry of Safiglipron.

Shown: Active compound as represented in the named PubChem record; formulation excipients excluded.

A two-dimensional chemical diagram shows bonds and stereochemistry, not a measured three-dimensional shape. PubChem lists HRS-7535 as a synonym of safiglipron; the alias was verified in the downloaded synonyms record.

PubChem, National Library of Medicine

PubChem CID 166094939

Development timeline

Next milestone

A next milestone is not summarized for this therapy. This does not mean development has ended.

Development history3 selected milestones

HRS-7535 (KAI-7535) · compound history across indications

Selected milestones only. Earlier studies may be missing; the first listed date should not be interpreted as the start of development.

  1. Kailera acquires regional rights

    Hengrui licensed the metabolic portfolio to Kailera for worldwide development and commercialization outside Greater China.

    Source
  2. Global phase 2 trial underway

    Kailera reported initiation of a global obesity study evaluating doses up to 360 mg over 44 weeks.

    Source
  3. HARBOR-1 phase 3 topline results

    The Chinese obesity trial met its primary endpoint; the 180 mg arm reported 9.8% treatment-policy weight loss at 44 weeks.

    Source

Selected sources checked Sep 13, 2026. This is not an exhaustive history.