NCT06813651 (Co-STARS) is a Phase 2 clinical trial of TBO-309: 60 mg in Ischemic Stroke, sponsored by ThromBio Pty. Ltd..

Who is sponsoring NCT06813651?

NCT06813651 is sponsored by ThromBio Pty. Ltd..

What drugs are being tested in NCT06813651?

Interventions in NCT06813651: TBO-309: 60 mg, TBO-309: 120 mg, TBO-309: 30 mg.

What condition does NCT06813651 study?

NCT06813651 studies Ischemic Stroke, Tandem Occlusion.

Is NCT06813651 still recruiting?

NCT06813651 is currently recruiting now. Last updated 25 November 2025.

Last reviewed 2025-11-25 · How we verify

NCT06813651: Co-STARS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety, Tolerability and Efficacy of Adjunctive TBO-309 in Reperfusion for Stroke With Tandem Occlusion

Recruiting now Phase 2 Last updated 25 November 2025

What this trial tests

Phase 2 trial testing TBO-309: 60 mg in Ischemic Stroke in 78 participants. Currently enrolling.

Timeline

4 October 2025

Primary endpoint
30 December 2026

31 December 2026

Quick facts

Lead sponsor	ThromBio Pty. Ltd.
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	single
Primary purpose	treatment
Enrollment	78
Start date	4 October 2025
Primary completion	30 December 2026
Estimated completion	31 December 2026
Sites	2 locations across Australia

Drugs / interventions tested

TBO-309: 60 mg — full drug profile →
TBO-309: 120 mg — full drug profile →
TBO-309: 30 mg — full drug profile →

Conditions studied

Ischemic Stroke — all drugs for Ischemic Stroke →
Tandem Occlusion — all drugs for Tandem Occlusion →

Sponsor

ThromBio Pty. Ltd. — full company profile →

Who can join

18 and older, any sex, with Ischemic Stroke or Tandem Occlusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Co-STAR is a multicenter, prospective, open-label, Bayesian Optimal Phase 2 (BOP2) trial that aims to assess the safety and efficacy of adjunctive intravenous TBO-309 in Acute Ischaemic Stroke (AIS) patients with tandem occlusion receiving intra-cranial endovascular thrombectomy (EVT) and acute extracranial carotid artery stenting. Co-STARS study will test the hypothesis that patients with tandem occlusion treated with EVT and acute stenting in conjunction with TBO-309 will: * have persistent stent patency without requiring rescue therapy with GPIIb/IIIa inhibitors and * not experience high rates of symptomatic intra-cranial haemorrhage (sICH). Patients with tandem occlusion undergoing EVT and acute stenting will receive intravenous TBO-309 bolus and infusion. TBO-309 is a potent, selective and ATP competitive PI3K\[beta\] inhibitor which reduces platelet activation adhesion/aggregation particularly under conditions of disturbed blood flow and promotes platelet disaggregation. By targeting PI3K\[beta\], TBO-309 specifically inhibits thrombosis whilst minimizing the impact on normal hemostasis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Ischemic Stroke

Currently open trials in the same condition.

NCT07509645 — Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Post · Phase 3 · recruiting
NCT07375953 — Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK) · Phase 2 · recruiting
NCT07375966 — Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours · Phase 2 · recruiting
NCT07491952 — Continuous Dual Aspiration Technique With Zoom System for Stroke · recruiting
NCT07371455 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06813651 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ThromBio Pty. Ltd.
Last refreshed: 25 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06813651.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing