What is tregzi used for?

tregzi is an FDA-approved medication. See full prescribing information for approved uses.

Is tregzi FDA approved?

Yes, tregzi is FDA approved (first approved 2026-06-30) and manufactured by Orca Biosystems Inc..

tregzi is manufactured by Orca Biosystems Inc..

Is tregzi a biologic?

Yes, tregzi is a biologic (BLA).

Data updated: Nov 8, 2026

tregzi (allogeneic regulatory t cell immunotherapy with hspc and t cells-vldq) · Orca Biosystems Inc.

Approved 2026-06-30

Jump to: Indications Approvals Trials Competitors Safety Patents

Indication

Phase 3 Trials

Years on Market

Details

Status: Prescription
First Approved: 2026-06-30
Routes: Intravenous
Dosage Forms: Solution

Companies

Orca Biosystems Inc.

Active Ingredient: allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq

Latest tregzi News

All tregzi news →

Nov 6, 2026 Trials · Orca Bio
Orca Bio to Present New Data on TREGZI® and the Company’s Clinical Pipeline at the 68th Annual American Society of Hematology Annual Meeting ↗
Sep 22, 2026 Trials · Orca Bio
Orca Bio Announces the Publication of TREGZI™ Long-Term Overall Survival Data in Transplantation and Cellular Therapy ↗
Sep 1, 2026 Trials · Orca Bio
Orca Bio to Present Clinical Data on TREGZI™ and Its Clinical Pipeline at the 14th Annual Meeting of the Society of Hematologic Oncology ↗

tregzi Approval History

Original

New Indication

New Form

Label Update

1 FDA actions from 2026 to 2026

Jun 2026 ORIGINAL

Update · CBER biologic (Purple Book)

What tregzi Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

Other (1)

🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

| Show all trials (incl. adjuvant)

Understanding FDA Approval Types

Count	Type	What it means
-	ORIG	Original approval - drug first enters market
-	SUPPL - Efficacy	New indication (new disease/condition approved)
-	SUPPL - Labeling	Label text changes (warnings, dosing updates)
-	SUPPL - Manufacturing	Production changes (new facility)
-	SUPPL - Chemistry	Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

tregzi FDA Label Details

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Data Sources

FDA Approval: BLA125868 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.