TheraRadar
Data updated: May 26, 2026

Aucatzyl (obecabtagene autoleucel)

Approved 2024-11-07
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Years on Market

Details

Status
Prescription
First Approved
2024-11-07
Patent Cliff
2036

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Routes
Intravenous
Dosage Forms
Suspension

Companies

Autolus, Inc.
Active Ingredient: Obecabtagene autoleucel

Aucatzyl Approval History

2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2024 to 2024
Nov 2024 ORIGINAL
Update · CBER biologic (Purple Book)

What Aucatzyl Treats

1 FDA approvals

Originally approved for its first indication in 2024 .

  • Other (1)
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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT07053059 2025-0580 NCI-2025-04660 Ph 2 recruiting Phase 2 Study Assessing the Clinical Activity and Safety of Obecabtagene Autoleucel as a Consolidation in Patients With Newly Diagnosed High-risk B-cell Acute Lymphocytic Leukemia (ALL)
NCT07053800 LUMINA AUTO1-SL2 2024-519941-32, 1011415 Ph 2 recruiting Obe-cel in Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis
NCT07400029 25-342 Ph 2 recruiting A Study of Obecabtagene Autoleucel in People With B-cell Acute Lymphoblastic Leukemia
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

Aucatzyl FDA Label Details

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Data Sources

FDA Approval: BLA125813 → Trials: ClinicalTrials.gov →

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