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Encelto FDA Approval History

Last updated by Judith Stewart, BPharm on March 6, 2025.

FDA Approved: Yes (First approved March 5, 2025)
Brand name: Encelto
Generic name: revakinagene taroretcel-lwey
Dosage form: Intravitreal Implant
Previous Name: NT-501
Company: Neurotech Pharmaceuticals, Inc.
Treatment for: Macular Telangiectasia Type 2

Encelto (revakinagene taroretcel-lwey) is an allogeneic encapsulated cell-based gene therapy indicated for the treatment of adults with idiopathic macular telangiectasia type 2.

Development timeline for Encelto

DateArticle
Mar  6, 2025Approval FDA Approves Encelto (revakinagene taroretcel-lwey) for the Treatment of Macular Telangiectasia Type 2 (MacTel)
Nov  8, 2024Neurotech Provides Update on BLA for NT-501 as a Treatment for Macular Telangiectasia Type 2 (MacTel)
Jun 20, 2024Neurotech Pharmaceuticals, Inc. Receives Priority Review of Biologics License Application (BLA) for NT-501 (revakinagene taroretcel) as a Treatment for Macular Telangiectasia Type 2 (MacTel)
Nov  2, 2022Neurotech Pharmaceuticals, Inc. Announces Positive Phase 3 Topline Results for NT-501 Implant in Macular Telangiectasia Type 2

Further information

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