Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 141

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 141
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acetylates histones and nonhistone proteins including transcription factors. The SIRT1-regulated pathway affects metabolism, stress
resistance, cell survival, cellular senescence, inflammation/immune function, endothelial functions, and circadian rhythms. Resveratrol
has been documented in scientific literature to activate SIRT1, NrF2, NLR3P inflammasomes and have an epigenetic mechanism, and therefore,
is predicted to benefit diseases affected by abnormal metabolic control, inflammation, and cell cycle defects. Nonetheless, resveratrol
application is a major challenge for the pharmaceutical industry, due to its poor solubility and bioavailability, as well as severe gastro-intestinal
side effects when taken at effective dose levels (over 2,000 mg daily).

Resveratrol has never before
been developed with all the necessary steps to achieve an approval as a pharmaceutical product since the existing natural supplements
cannot provide high enough levels of resveratrol in blood plasma to be able to provide a therapeutically effective dose without generating
severe gastro-intestinal side effects. This means that we need to take JOTROL™ through the full regulatory NDA (New Drug
Application) requirement to obtain a prescription marketing approval in the USA.

JOTROL

JOTROL™ was
developed together with our technology partner Aquanova, headquartered in Darmstadt, Germany. JOTROL™ is formulated with
a unique patented micellar technology that is projected to increase the bioavailability profile of resveratrol. Manufacturing technology
transfers were completed in 2017, and manufacturing procedures and clinical trial supply manufacturing have been completed at Catalent
Pharmaceutical Services, Inc. (“Catalent”), St Petersburg, Florida. Catalent is also in process to manufacture the clinical
trial supplies for our Phase IIa trial in Parkinson’s Disease.

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JOTROL™ is a
micellar non-aqueous solution of resveratrol delivered in a softgel capsule. Each capsule includes 100mg of resveratrol. Pre-clinical
trials in mice and rats were conducted comparing JOTROL™ to micronized resveratrol, labeled to have the highest bioavailability
in the nutritional market, to demonstrate that we could achieve a significantly higher bioavailability. A Phase I dose finding pharmacokinetic
(“PK”) study in healthy volunteers was completed during the first half of 2021. The study results met our targeted