This section highlights FDA-related milestones and regulatory updates for drugs developed by ChromaDex (CDXC).
Over the past two years, ChromaDex has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Niagen and nicotinamide. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Niagen - FDA Regulatory Timeline and Events
Niagen is a drug developed by ChromaDex for the following indication: Nicotinamide Riboside Chloride or NRC.
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:
- Niagen
- Announced Date:
- September 10, 2024
- Indication:
- Nicotinamide Riboside Chloride or NRC
Announcement
ChromaDex Corp. announce the second wave of intravenous (IV) wellness clinics that will offer pharmaceutical-grade Niagen® (nicotinamide riboside chloride or NRC), branded Niagen+, in intravenous (IV) and injectable forms.
AI Summary
ChromaDex Corp. announced the second wave of intravenous (IV) wellness clinics that will now offer its pharmaceutical-grade Niagen® (nicotinamide riboside chloride), branded as Niagen+, in both IV and injectable forms. This new rollout is part of an expansion where an FDA-registered 503B outsourcing facility, Wells Pharma of Houston, will compound and distribute the product to 14 additional clinics across key U.S. regions. Niagen+ is designed to support enhanced cellular energy production and DNA repair by rapidly elevating NAD+ levels, which are essential for cell health. ChromaDex is excited about the strong interest and rapid adoption of Niagen+ among leading wellness clinics, with plans to announce even more locations soon. The IV and injection forms offer quicker administration and improved patient tolerability, making them a promising option for those seeking advanced wellness and longevity solutions.
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nicotinamide adenine dinucleotide - FDA Regulatory Timeline and Events
nicotinamide adenine dinucleotide is a drug developed by ChromaDex for the following indication: for the Treatment of Ataxia Telangiectasia (AT).
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:
- nicotinamide adenine dinucleotide
- Announced Date:
- June 7, 2024
- Indication:
- for the Treatment of Ataxia Telangiectasia (AT)
Announcement
ChromaDex Corp announced that the U.S. Food & Drug Administration (FDA) granted Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) Designation for NRC, the company's product candidate for the treatment of Ataxia Telangiectasia (AT).
AI Summary
ChromaDex Corp has received strong support from the FDA, which granted both Orphan Drug Designation and Rare Pediatric Disease Designation for its product candidate, NRC, aimed at treating Ataxia Telangiectasia (AT). This significant milestone recognizes NRC’s potential as a treatment option for a serious disorder that affects children, leading to symptoms like poor coordination, balance issues, and a drastically reduced life expectancy.
The designations offer important benefits, including tax credits and potential market exclusivity, to help bring this treatment to patients more quickly. In addition, ChromaDex is preparing to file an Investigational New Drug (IND) application, marking a crucial step toward starting human clinical trials under expert guidance. These efforts promise to enhance hope and treatment options for those suffering from AT.
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