Aucatzyl (obecabtagene autoleucel) · Autolus, Inc.
Details
- Status
- Prescription
- First Approved
- 2024-11-07
- Patent Cliff
- 2036
- Routes
- Intravenous
- Dosage Forms
- Suspension
Aucatzyl Approval History
What Aucatzyl Treats
1 FDA approvalsOriginally approved for its first indication in 2024 .
- Other (1)
Other
(1 approval)- • Approved indication (Nov 2024)
Aucatzyl Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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 (SLE) With Active Lupus Nephritis (LN) |
| NCT07400029 | 25-342 | Ph 2 | recruiting | A Study of Obecabtagene Autoleucel in People With B-cell Acute Lymphoblastic Leukemia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
Data sourced from official FDA and NIH databases. Click links to verify on original sources.