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.
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
Grafico Azioni ChromaDex (NASDAQ:CDXC)
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Da Dic 2024 a Gen 2025
Grafico Azioni ChromaDex (NASDAQ:CDXC)
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Da Gen 2024 a Gen 2025
