Chemistry:Revakinagene taroretcel
| Clinical data | |
|---|---|
| Trade names | Encelto |
| Other names | NTC-201-6A, revakinagene taroretcel-lwey |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a625063 |
| License data | |
| Routes of administration | Intravitreal implantation |
| ATC code |
|
| Legal status | |
| Legal status | |
| Identifiers | |
| UNII | |
| KEGG | |
Revakinagene taroretcel, sold under the brand name Encelto, is an allogeneic encapsulated cell-based gene therapy used for the treatment of macular telangiectasia type 2.[1][3] Revakinagene taroretcel is administered into the recipient's eye during a single surgical procedure.[4]
Revakinagene taroretcel works by expressing recombinant human ciliary neurotrophic factor, which is a factor that may promote the survival and maintenance of the macular photoreceptors.[4]
Revakinagene taroretcel was approved for medical use in the United States in March 2025.[4][2]
Medical uses
Revakinagene taroretcel is indicated for the treatment of adults with idiopathic macular telangiectasia type 2.[1][2]
Macular telangiectasia type 2 is a rare progressive disease of the macula (portion of the eye that process sharp central vision), leading to degeneration of the photoreceptors which are specialized light-detecting cells in the back of the eye.[4]
Society and culture
Legal status
Revakinagene taroretcel was approved for medical use in the United States in March 2025.[2][5]
Names
Revakinagene taroretcel is the international nonproprietary name[6] and the United States Adopted Name.[7]
References
- ↑ 1.0 1.1 1.2 "Encelto- revakinagene taroretcel-lwey implant". 21 March 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ae9482a-b478-4e21-9166-b5fd52d3ef9c.
- ↑ 2.0 2.1 2.2 2.3 "Encelto". 1 October 2024. https://www.fda.gov/vaccines-blood-biologics/center-biologics-evaluation-and-research-cber-product-approval-information/encelto.
- ↑ "Recent and anticipated novel drug approvals (3Q 2024 through 2Q 2025)". American Journal of Health-System Pharmacy 81 (22): 1103–1108. November 2024. doi:10.1093/ajhp/zxae242. PMID 39194065.
- ↑ 4.0 4.1 4.2 4.3 "FDA Roundup: March 7, 2025". 7 March 2025. https://www.fda.gov/news-events/press-announcements/fda-roundup-march-7-2025.
This article incorporates text from this source, which is in the public domain.
- ↑ "Neurotech's Encelto (revakinagene taroretcel-lwey) Approved by the FDA for the Treatment of Macular Telangiectasia Type 2 (MacTel)" (Press release). Neurotech. 6 March 2025. Retrieved 7 March 2025 – via Business Wire.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85". WHO Drug Information 35 (1). 2021.
- ↑ "Revakinagene taroretcel". https://searchusan.ama-assn.org/finder/usan/search/LM-47/relevant/1/.
External links
- Clinical trial number NCT03316300 for "A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol A" at ClinicalTrials.gov
- Clinical trial number NCT03319849 for "A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol B" at ClinicalTrials.gov
 |  |
