Niagen Bioscience's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Niagen Bioscience (NAGE).
Over the past two years, Niagen Bioscience has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
NB4168. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
NB4168 FDA Regulatory Events
NB4168 is a drug developed by Niagen Bioscience for the following indication: Treatment Of Ataxia Telangiectasia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NB4168
- Announced Date:
- August 3, 2026
- Indication:
- Treatment Of Ataxia Telangiectasia
Announcement
Niagen Bioscience, Inc announced that it has selected Evotec a global life science company specializing in drug discovery and development, as a contract research organization to support the advancement of NB4168.
AI Summary
Niagen Bioscience reported new human research suggesting that its nicotinamide riboside (NR) supplement, Niagen, may help reduce biological aging in skeletal muscle. The study found changes in epigenetic aging markers, indicating that NR may affect how genes linked to aging are regulated, rather than only raising NAD+ levels or supporting mitochondrial activity. Researchers compared the effects of NR and exercise, including high-intensity interval training, across several biological clocks and tissue types. The findings support further study of NAD+ restoration as a potential way to promote healthier muscle aging, although the results remain preliminary and the effects appear complex.
Separately, Niagen Bioscience announced that it selected Evotec, a global life science company specializing in drug discovery and development, as a contract research organization for NB4168. Evotec will support the program’s advancement, adding specialized research and development expertise as Niagen continues investigating the candidate.
Read Announcement- Drug:
- NB4168
- Announced Date:
- July 13, 2026
- Indication:
- Treatment Of Ataxia Telangiectasia
Announcement
NNiagen Bioscience Receives FDA Rare Pediatric Disease Designation For Its Drug Candidate NB4168 For The Treatment Of Ataxia Telangiectasia
AI Summary
NNiagen Bioscience said its drug candidate NB4168 received Rare Pediatric Disease designation from the U.S. Food and Drug Administration for the treatment of ataxia telangiectasia, a rare and serious disease that mainly affects children. The company said the recognition supports its plan to develop a therapy for a condition with no approved treatments. It also sees the designation as an important sign of support for NB4168 and its broader work in rare disease medicines.
Ataxia telangiectasia is a progressive disorder that can cause trouble with movement, immune problems, and other health issues. NNiagen Bioscience said the FDA designation may help speed development and give the program added visibility. The company said it believes NB4168 could become an important new option for patients and families facing this unmet medical need.
Read Announcement
Niagen Bioscience FDA Events - Frequently Asked Questions
As of now, Niagen Bioscience (NAGE) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Niagen Bioscience (NAGE) has reported FDA regulatory activity for NB4168.
The most recent FDA-related event for Niagen Bioscience occurred on August 3, 2026, involving NB4168. The update was categorized as "Provided Update," with the company reporting: "Niagen Bioscience, Inc announced that it has selected Evotec a global life science company specializing in drug discovery and development, as a contract research organization to support the advancement of NB4168."
Currently, Niagen Bioscience has one therapy (NB4168) targeting the following condition: Treatment Of Ataxia Telangiectasia.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:NAGE last updated on 8/3/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
