ChromaDex to Launch Niagen+, the First-Of-Its-Kind Pharmaceutical-Grade Intravenous and Injectable Niagen® (Patented Nicotinamide Riboside Chloride or NRC)

Rhea-AI Summary

ChromaDex is set to launch Niagen+, the first pharmaceutical-grade intravenous and injectable Niagen (Nicotinamide Riboside Chloride or NRC).

FDA-approved for compounding by 503B outsourcing facilities, Niagen+ IV and injectable forms will be available at clinics nationwide starting August 2024. A clinical study showed no adverse side effects, superior tolerability, and a faster infusion time compared to NAD+ IV, with blood NAD+ levels peaking higher and sooner.

Niagen+ aims to transform the $2.32 billion global intravenous hydration therapy market. ChromaDex holds over 80 patents for its NAD+ precursors, ensuring robust IP protection.

Positive

• FDA approval for compounding by 503B outsourcing facilities.
• Superior tolerability and 75% shorter infusion time compared to NAD+ IV.
• No adverse side effects reported in clinical trials.
• Potential to transform the $2.32 billion global intravenous hydration therapy market.
• Strong IP protection with over 80 patents.

Negative

• initial availability at select clinics starting in August 2024.
• Need for additional data from larger participant groups to validate findings.

Insights

Medical Research Analyst

ChromaDex's launch of Niagen+ introduces a novel approach in the NAD+ enhancement sector, leveraging their patented nicotinamide riboside chloride (NRC) in an intravenous (IV) and injectable format. The clinical study results indicating superior tolerability and a shorter infusion time for Niagen IV versus NAD+ IV significantly bolster the product's value proposition. The study also found that blood NAD+ levels peak sooner and higher with Niagen IV, providing a distinct competitive edge.

For retail investors, it's important to note that the product's differentiation stems from its ability to deliver benefits more efficiently and with fewer side effects compared to existing options. This aspect is particularly meaningful given the growing demand among athletes, celebrities and those interested in longevity, who are likely to be early adopters.

Given the FDA's authorization for NRC compounding and the lack of adverse side effects reported in clinical trials, Niagen IV's market entry appears well-timed and strategically sound. However, the claim that NAD+ supplementation via IV may induce an immune response, contrasting with NRC's mechanism, underscores the importance of understanding the underlying biomedical nuances and potential long-term effects. Investors should watch for further clinical data as ChromaDex scales its research efforts.

Financial Analyst

From a financial perspective, ChromaDex's introduction of Niagen+ is positioned to capitalize on the expansive intravenous hydration therapy market, valued at 2.32 billion globally. This move into pharmaceutical-grade products indicates strategic diversification and a potential for significant revenue growth, especially given the exclusive nature of the product combined with existing direct-to-consumer offerings.

ChromaDex's robust intellectual property portfolio, with over 80 owned and licensed patents, provides a formidable barrier to entry for competitors. This strong IP position not only fortifies their market position but also assures investors of long-term revenue protection. The limited initial rollout in select clinics, with plans for broader availability, suggests a cautious but calculated approach to scaling the product, which minimizes risk while testing market receptivity.

Investors should monitor the adoption rate and feedback from the early clinic deployments closely. Additionally, tracking subsequent financial quarters for revenue impact and any incremental costs associated with this new vertical will be essential to gauge the financial viability and long-term profitability.

Market Research Analyst

Niagen+ entering the market as a pharmaceutical-grade NRC product taps into the growing trend of health optimization through advanced supplementation. The product's potential to differentiate itself through clinical efficacy and fewer side effects is notable, particularly within the high-value demographic of athletes and longevity enthusiasts. The claim of faster and higher NAD+ level peaking aligns well with consumer demand for efficient and effective health solutions.

However, the success of Niagen+ will depend on its market positioning and the ability to educate potential users about the distinct benefits of NRC over NAD+. The FDA authorization adds credibility, but the educational component will be vital given the complexities involved in understanding NAD+ biochemistry. Additionally, ChromaDex's strategy to utilize 503B compounding facilities ensures that the product reaches its target audience through a regulated and reliable distribution channel.

Investors should be aware of the potential market size, estimated by ChromaDex to exceed 100 million in North America, which provides a substantial growth opportunity. Observing how well ChromaDex can operationalize its strategy and penetrate this niche market will be key to assessing long-term value.

Clinical study results demonstrated that Niagen IV had no adverse side effects, provided superior tolerability, and a 75% shorter infusion time, with blood NAD+ levels peaking sooner and higher three hours post-infusion as compared to NAD+ IV.

The U.S. FDA authorized nicotinamide riboside chloride (NRC) for compounding by 503B outsourcing facilities, which will soon be available to ship to clinics nationwide.

LOS ANGELES--(BUSINESS WIRE)-- ChromaDex Corp. (NASDAQ:CDXC), the global authority on nicotinamide adenine dinucleotide (NAD+) research and its application to healthy aging, unveils Niagen+, the first-of-its-kind pharmaceutical-grade Niagen^® (patented nicotinamide riboside chloride or NRC). Authorized by the U.S. FDA for compounding by 503B outsourcing facilities, pharmaceutical-grade intravenous (IV) and injectable NRC will be available in IV, shot, and push forms exclusively at clinics, with a prescription. ChromaDex believes it will be the first company in the U.S. to offer a novel ingredient (Niagen) both as a direct-to-consumer dietary supplement, available globally as Tru Niagen^®, and as an intravenous and injectable pharmaceutical-grade product, available only at clinics. Various patents, including a pending patent covering NRC and other NAD+ precursors for intravenous use, offer extensive protection for pharmaceutical-grade Niagen.

“NAD+ IV has gained popularity amongst celebrities, athletes, and longevity experts because of the substantial benefits but the experience can be unpleasant,” said Rob Fried, CEO of ChromaDex. “Niagen IV is much faster, provides superior tolerability, and importantly elevates NAD+ levels quicker and higher¹. We believe Niagen IV will transform the NAD+ landscape.”

Pharmaceutical-grade Niagen, including Niagen IV, will debut in limited quantities at select clinics starting in August and will soon be available for shipping to additional clinics nationwide. Visit www.niagenplus.com to sign up for updates on future clinic availability.

Intravenous and injectable Niagen is the new 2024 vertical previously mentioned by ChromaDex. Niagen IV has the potential to reach the global intravenous hydration therapy market, which was valued at “USD $2.32 billion globally and USD $1.15 billion in North America (2022),” according to Grand View Research. This includes the NAD+ IV market, which ChromaDex estimates has the potential to be valued at over $100 million in North America alone (2023).

Findings from the first-ever human clinical trial recently published as a preprint in MedRxiv demonstrated that 500mg of Niagen IV was well-tolerated, with no adverse side effects. In a head-to-head comparison with the mainstream alternative, NAD+ IV, Niagen IV provided superior tolerability and a 75% shorter infusion time, with blood NAD+ levels peaking sooner and higher three hours post-infusion. In addition to a longer infusion time, study results showed that NAD+ IV was associated with a high prevalence of uncomfortable side effects such as headaches, stomach pain, diarrhea, and nausea, which were not observed with Niagen IV. ChromaDex looks forward to generating additional data from larger participant groups to quantify and validate these findings.

Dr. Charles Brenner, Alfred E. Mann Family Foundation Chair in Diabetes and Cancer Metabolism at the City of Hope, Chief Scientific Advisor to ChromaDex—and the world’s foremost NAD+ expert—commented, “I am pleased that ChromaDex has developed an impeccably pure Niagen IV formulation, which is demonstrating a less stressful experience than NAD+ IV. I am confident that Niagen IV will be the gold standard IV material used to test NAD+ boosting for health conditions, and I look forward to future research.”

Although a common misconception, supplementing with oral or intravenous NAD+ itself is not the most efficient and effective way to elevate cell and tissue NAD+ levels. As a large, phosphorylated molecule, NAD+ cannot pass through cell membranes and must first be broken down into other NAD+ precursors. Studies suggest that intact NAD+ causes an acute immune inflammatory response, which may be responsible for the uncomfortable side effects associated with NAD+ IV and injection. Oral and intravenous NAD+ supplementation is virtually untested in humans, thus risks, safety, and efficacy are unknown. Unlike the NAD+ molecule itself, or other common NAD+ precursors, NR is the most efficient way to elevate NAD+ levels because it crosses the cell membrane directly and requires fewer steps for conversion into NAD+. (Nikiforov et al., 2011, Mehmel et al. 2020, Kroptov et al., 2021).

“Niagen IV not only has the potential to help millions looking to support healthspan, but also may provide an option for those dealing with health-related conditions,” said Dr. Bal Nandra, Founder and Medical Director at IV Solution and Ketamine Centers of Chicago. “We are thrilled with the clinical study results and look forward to future research as Niagen IV sets a new standard in the NAD+ industry.”

ChromaDex has a robust intellectual property (IP) portfolio of 80+ owned and licensed patents protecting Niagen and other NAD+ precursors. Various patents offer extensive protection for pharmaceutical-grade Niagen. It would be difficult for a company to produce NR, including NR chloride and other salt forms of NR, commercially without violating one or more of these patents. ChromaDex has vigorously protected and will continue to protect the hard-earned assets of shareholders.

For additional updates, please visit www.niagenplus.com.

Forward-Looking Statements:

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as "expects," "anticipates," "intends," "estimates," "plans," "potential," "possible," "probable," "believes," "seeks," "may," "will," "should," "could" or the negative of such terms or other similar expressions, and include the statements regarding Niagen IV being available starting in August and nationwide thereafter; Niagen IV’s potential to reach the global intravenous hydration therapy market; the potential health benefits of Niagen IV; and the potential for Niagen IV to materially impact the overall NAD+ industry. These forward-looking statements are based on the Company’s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to the Company’s ability to secure adequate pharmaceutical grade quantities of Niagen IV in a timely manner; the Company’s ability to obtain appropriate contracts and arrangements with U.S. FDA-registered 503B outsourcing facilities required to distribute Niagen IV to IV clinics; the Company’s ability to remain on the U.S. FDA Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Category 1 list; the Company’s ability to maintain and enforce the Company’s existing intellectual property and obtain new patents related to Niagen IV; the Company’s ability to maintain sales, marketing and distribution capabilities; changing consumer perceptions of the Company’s products; the Company’s reliance on a single or limited number of third-party suppliers; and the risks and uncertainties associated with the Company’s business and financial condition. More detailed information about ChromaDex and the risk factors that may affect the realization of forward-looking statements is set forth in ChromaDex's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, ChromaDex's Quarterly Reports on Form 10-Q and other filings submitted by ChromaDex to the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.

About ChromaDex:

ChromaDex Corp. (NASDAQ:CDXC) is the global authority on nicotinamide adenine dinucleotide (NAD+), with a focus on the science of healthy aging. The ChromaDex team, comprised of world-renowned scientists, works with independent investigators from esteemed universities and research institutions around the globe to uncover the full potential of NAD+. A vital coenzyme found in every cell of the human body, NAD+ declines with age and exposure to other everyday stressors. NAD+ depletion is a contributor to age-related changes in health and vitality. Setting the benchmark as the gold standard in scientific rigor and quality in the dietary supplement space, ChromaDex is the innovator behind its clinically proven flagship ingredient, Niagen^® (patented nicotinamide riboside, or NR). Clinically proven to increase NAD+ levels, Niagen is the most efficient and superior-quality NAD+ booster helping people transform the way they age.

Food-grade Niagen is manufactured by Chromadex and is available in the consumer dietary supplement Tru Niagen^®, the number one healthy-aging oral NAD+ supplement in the United States* (available at www.truniagen.com). Pharmaceutical-grade Niagen will be available through FDA-registered 503B outsourcing facilities and will be administered at clinics pursuant to a valid prescription (www.niagenplus.com).

ChromaDex’s robust patent portfolio protects NR and other NAD+ precursors. ChromaDex maintains a website at www.chromadex.com, to which ChromaDex regularly publishes copies of its press releases, news, and financial information.

*Based on the top-selling dietary supplement brands by revenue per the largest U.S. e-commerce marketplace (as of 3/1/2023-2/29/2024).

¹ Hawkins, J., Idoine, R., Kwon, J., Shao, A., Dunne, E., Hawkins, E. et al. (2024) Randomized, placebo-controlled, pilot clinical study evaluating acute Niagen+ IV and NAD+ IV in healthy adults. https://doi.org/10.1101/2024.06.06.24308565

View source version on businesswire.com: https://www.businesswire.com/news/home/20240613823864/en/

ChromaDex Media Contact:

Kendall Knysch, Senior Director of Public Relations & Partnerships

310-388-6706 ext. 689

kendall.knysch@chromadex.com

ChromaDex Investor Relations Contact:

Ben Shamsian

Lytham Partners

646-829-9701

shamsian@lythampartners.com

Source: ChromaDex Corporation

FAQ

What is ChromaDex's new product Niagen+?

Niagen+ is a pharmaceutical-grade intravenous and injectable Nicotinamide Riboside Chloride (NRC) authorized by the FDA for compounding by 503B outsourcing facilities.

When will Niagen+ be available?

Niagen+ will debut in quantities at select clinics starting in August 2024 and will soon be available for shipping to additional clinics nationwide.

What are the benefits of Niagen IV compared to NAD+ IV?

Niagen IV offers superior tolerability, a 75% shorter infusion time, and higher blood NAD+ levels three hours post-infusion, with no adverse side effects reported.

How is ChromaDex protecting its Niagen product?

ChromaDex has a robust IP portfolio with over 80 owned and licensed patents protecting Niagen and other NAD+ precursors.

What is the market potential for Niagen+?

Niagen+ aims to reach the global intravenous hydration therapy market, valued at $2.32 billion globally, including an estimated $100 million potential in North America for NAD+ IV.