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NiagenPlus · 1 trial · 2 indications
The incidence and severity of treatment-associated moderate and severe adverse events (AEs) will be assessed.
Blood pressure, systolic and diastolic, will be measured
Heart rate will be measured.
Pulse rate will be measured.
Respiratory rate will be measured.
Blood oxygen level will be measured.
A complete blood count with differential will be evaluated through whole blood samples
Comprehensive metabolic panel will be evaluated through whole blood samples
Homocysteine will be measured from venous blood samples as part of the primary safety laboratory panel. Levels will be analyzed as absolute values and change-from-baseline to evaluate any clinically significant elevations or shifts associated with repeat dosing of Niagen®Plus.
High-sensitivity C-reactive protein will be assessed from venous blood samples as part of the primary safety laboratory panel. hs-CRP is a sensitive biomarker of systemic inflammation and may signal acute or sub-acute inflammatory responses to repeated Niagen®Plus dosing. Levels will be analyzed as absolute values and change-from-baseline to identify any clinically meaningful elevations or trends. Data will be summarized descriptively by dose and route of administration to support safety evaluation.
| Arm | Type | Description |
|---|---|---|
| 50 mg Subcutaneous Niagen®Plus | EXPERIMENTAL | Participants receive 50 mg Niagen®Plus administered subcutaneously (under the skin) once daily for three consecutive days during in-clinic visits (Days 1-3). Participants then continue self-administered subcutaneous injections of the same dose three times per week (Monday, Wednesday, Friday) from Days 10-100. |
| 100 mg Subcutaneous Niagen®Plus | EXPERIMENTAL | Participants receive 100 mg Niagen®Plus administered subcutaneously once daily for three consecutive days during in-clinic visits (Days 1-3). Participants then continue self-administered subcutaneous injections of the same dose three times per week (Monday, Wednesday, Friday) from Days 10-100. |
| 50 mg Intramuscular Niagen®Plus | EXPERIMENTAL | Participants receive 50 mg Niagen®Plus administered intramuscularly (into the deltoid muscle) once daily for three consecutive days during in-clinic visits (Days 1-3). No further at-home injections are performed; participants return for follow-up visits on Days 10, 40, and 100. |
| 100 mg Intramuscular Niagen®Plus | EXPERIMENTAL | Participants receive 100 mg Niagen®Plus administered intramuscularly (into the deltoid muscle) once daily for three consecutive days during in-clinic visits (Days 1-3). No further at-home injections are performed; participants return for follow-up visits on Days 10, 40, and 100. |
| Name | Type | Description |
|---|---|---|
| Niagen®Plus | DRUG | Pharmaceutical-grade nicotinamide riboside chloride (NRCl), compounded for sterility and reconstituted in bacteriostatic water for injection. Administered by subcutaneous or intramuscular injection at 50 mg or 100 mg per dose. Participants receive three clinician-administered injections during clinic visits on Days 1-3, followed by at-home subcutaneous self-administration three times per week (Monday, Wednesday, Friday) from Days 10-100, depending on study arm. |
Inclusion Criteria: * Generally healthy adults, aged 18+ * Demonstrated baseline fatigue as determined by a below average score from the FAS (threshold prespecified in SAP). * NAD+ or NAD+ precursor injection naïve (including intravenous, intramuscular, subcutaneous, or other injection route) (i.e....
NiagenPlus is being studied for fatigue. It is an investigational small molecule developed by Niagen Bioscience, Inc. and is currently in Phase 1 clinical development. The research includes healthy adult volunteers alongside the fatigue indication, and the program remains in early-stage testing rather than approved clinical use.
NiagenPlus targets NAD+, or nicotinamide adenine dinucleotide. NAD+ is a coenzyme involved in cellular energy metabolism, and the drug is designed to act on this target. This mechanism underlies its investigation in fatigue, a condition often associated with altered cellular energy production.
NiagenPlus is developed by Niagen Bioscience, Inc., which trades under the ticker NAGE. The company is the sponsor of the clinical program evaluating the drug. No other developers or partners are associated with NiagenPlus based on the current development information.
NiagenPlus is in Phase 1 clinical development. It has not been approved by the FDA and remains an investigational drug. The Phase 1 program is designed to assess safety, and the single ongoing trial is currently recruiting participants.
NiagenPlus is being evaluated in one active clinical trial, NCT07251608, titled a randomized, open-label safety study of subcutaneous and intramuscular injections of Niagen Plus. The trial is recruiting 40 participants in the United States, including healthy volunteers and people with fatigue, and has no completed trials to date.