Open label, randomised, one period one sequence, single dose, pharmacokinetic study to evaluate the bioavailability of Resveratrol and Pterostilbene after administration of single dose of NOVAGENERE-XAR and NOVAGENERE-XAP capsules in six healthy, adult, male human subjects under fasting conditions

Start Date15 Jul 2022

Sponsor / Collaborator

Epigeneres Biotech Pvt Ltd.

JPRN-jRCTs031210153

/ CompletedNot ApplicableIIT

A randomized, double-blind, controlled study of pterostilbene in aging infertile patients

Start Date16 Jun 2021

Sponsor / Collaborator-

100 Clinical Results associated with Pterostilbene

100 Translational Medicine associated with Pterostilbene

100 Patents (Medical) associated with Pterostilbene

1,307

Literatures (Medical) associated with Pterostilbene

01 May 2026·COLLOIDS AND SURFACES B-BIOINTERFACES

Design, characterization, and in vitro evaluation of Eudragit-coated aminated mesoporous silica nanoparticles loaded with pterostilbene for colon delivery

Article

Author: Raut, Nikhil ; Panda, Swornahuti ; N, Manasa ; Natesan, Subramanian ; Hmingthangsanga, Victor

Ulcerative colitis (UC), a chronic inflammatory colon disease, often requires long-term care. Pterostilbene (PTB), a naturally occurring substance with strong anti-inflammatory and antioxidant properties, has shown therapeutic potential; however, its poor aqueous solubility and instability at stomach pH limit its clinical application. A colon-targeted drug delivery system loaded with PTB and coated with Eudragit S100 (EU) was developed using mesoporous silica nanoparticles (MSN). The MSN were surface-aminated using 3-aminopropyl triethoxysilane (APTES) to obtain aminated mesoporous silica nanoparticles (AMSN), which provided pH-responsive release and enhanced drug binding. FT-IR spectroscopy confirmed the encapsulation of the drug and amine functionalization through characteristic spectral shifts. X-ray diffraction (XRD) showed decreased crystallinity of PTB, suggesting effective molecular dispersion within the MSN matrix. Differential scanning calorimetry (DSC) was used to confirm the amorphous form of the encapsulated medication. Morphological study using SEM and TEM revealed consistently spherical, porous nanoparticles. Thermogravimetric analysis (TGA) demonstrated the formulation's thermal stability, and Brunauer-Emmett-Teller (BET) analysis showed high surface area and pore volume, both of which are advantageous for efficient drug loading. In vitro release investigations confirmed a pH-dependent, extended release of the drug under intestinal conditions. Additionally, pro-inflammatory cytokines (TNF-α and IL-6) were significantly reduced in the ELISA assays of LPS-stimulated HT-29 cells, demonstrating the formulation's anti-inflammatory efficacy. The development of colon-specific delivery of pterostilbene, the Eudragit-coated PTB-loaded AMSN (Eu-PTB-AMSN), effectively addresses the primary shortcomings of conventional PTB formulations, including low solubility, stomach instability, and systemic adverse effects, while offering a practical therapeutic approach for the treatment of UC.

01 Apr 2026·BIORESOURCE TECHNOLOGY

Integrated dynamic control and enzyme co-localization strategies enable high-efficiency stilbenoid biosynthesis

Article

Author: Liu, Lin ; Zhang, Qiang ; Zi, Lihan ; Zhao, Guofu ; Li, Pengpai ; Liu, Rongming ; Ding, Xinyao ; Lv, Jiugong ; Yang, Ying ; Liang, Liya

Stilbenoids are plant-derived polyphenols with potent bioactivities, which makes them promising for pharmaceutical and nutraceutical use. Their production remains challenging due to their low natural abundance in plants and the inherent toxicity associated with chemical synthesis. Here, we developed an integrated strategy to engineer Escherichia coli for efficient biosynthesis of multiple stilbenoids. A p-coumaric acid-responsive CRISPRi system dynamically regulated malonyl-CoA allocation, balancing host metabolism and stilbenoid production. We systematically explored enzyme co-localization strategies and used structure-informed in silico analysis to support dual-enzyme fusion design. Orthogonal SpyTag/SpyCatcher and SnoopTag/SnoopCatcher systems enabled optimal intermediate channeling and significantly enhanced pathway flux. As a result, we achieved the highest reported titers of piceatannol (494.30 mg/L from glycerol, increased to 583.10 mg/L with l-tyrosine supplementation) and pterostilbene (563.89 mg/L from glycerol, reaching 1110.92 mg/L with l-tyrosine feeding). Techno-economic analysis indicated that combined optimization of metabolic regulation, enzyme co-localization, and process design contributes substantially to the overall feasibility of stilbenoid manufacturing. Altogether, this study demonstrates the potential of stilbenoid biosynthesis and provides a valuable paradigm for the efficient synthesis of other complex natural products.

01 Mar 2026·INTERNATIONAL IMMUNOPHARMACOLOGY

Hidden oral-joint-lung axis: Porphyromonas gingivalis Infection promotes the EMyT of RA-ILD by inhibiting the JUN-regulated palmitoylation balance

Article

Author: Li, Chunfeng ; Wang, Hongxing ; Zhang, Yi ; Liu, Zhipu ; Zhao, Na ; Pan, Hongwei

BACKGROUND:

Rheumatoid arthritis-associated interstitial lung disease (RA-ILD) is a major cause of mortality among patients with rheumatoid arthritis (RA), yet the pathological mechanism linking joint and lung involvement remains poorly understood. The pathogenic role of Porphyromonas gingivalis (P.g) in RA has been established. This study investigated how P.g infection drives RA-ILD through palmitoylation-mediated epithelial-myofibroblast transition (EMyT), thereby uncovering a mechanistic basis for the oral-joint-lung connection.

METHODS:

Metagenomic next-generation sequencing (mNGS) of bronchoalveolar lavage fluid and 16S rRNA sequencing of fecal samples from patients with RA-ILD were analyzed to assess the association between P.g and RA-ILD. A collagen-induced arthritis (CIA) mouse model and human lung epithelial cell lines (A549 and BEAS-2B) infected with P.g were established. Palmitoylation dynamics, EMyT marker expression, and the function of the hub gene JUN were evaluated using immunopathology, qPCR, western blotting (WB), single-cell sequencing, and molecular docking. Mechanistic studies employed the JUN activator c2-ceramide, the JUN inhibitor pterostilbene, and the palmitoylation inhibitor 2-BP to determine how P.g regulates palmitoylation in promoting RA-ILD.

RESULTS:

Both mNGS and 16S rRNA analyses revealed a strong association between Porphyromonas spp. infection and RA/RA-ILD. P.g infection significantly increased EMyT marker expression (collagen I, fibronectin, and vimentin) in vitro and induced pulmonary fibrosis in CIA-ILD mice, with palmitoylation playing a central role. Mechanistically, JUN was identified as a key regulator of palmitoylation. P.g suppressed JUN level, activated ZDHHC3, and inhibited PPT1, leading to palmitoylation imbalance. Activation of JUN by c2-ceramide, combined with inhibition of palmitoylation by 2-BP, effectively suppressed EMyT progression in RA-ILD.

CONCLUSION:

This study identifies a novel "oral-joint-lung axis" in which P.g infection promotes EMyT and fibrosis in RA-ILD by disrupting JUN-regulated palmitoylation homeostasis. Modulation of this axis provides a promising therapeutic strategy for RA-ILD.

News (Medical) associated with Pterostilbene

03 Jan 2024

·www.biospace.com

Therapeutic Solutions International Subsidiary Immunotherapy Company Res Nova Bio, Inc. Announces Positive Data on First Four Advanced Cancer Patients Treated with FloraStilbene™

Clinical Stage Oncology Biotech Leverages Active Ingredient in Abortion Pill to Induce Immunity to Cancer ELK CITY, Idaho--(BUSINESS WIRE)-- Therapeutic Solutions International, Inc. (TSOI), announced today that its Subsidiary Company Res Nova Biologics, successfully treated four advanced cancer patients with FloraStilbene™. The patients had no adverse events from drug administration and clinical signals of tumor response were observed. All patients have been followed-up with for more than three months. FloraStilbene™ is a drug comprising of a proprietary formulation of the abortion pill’s active ingredient (RU486) and pterostilbene. The drug is manufactured by Compounding Pharmacy Cure Stat1 and is available by prescription under Right To Try. Previously, the Company has demonstrated efficacy of FloraStilbene in stimulating immune responses in animal models of various cancers, with an emphasis on triple negative breast tumor models2. The use of pterostilbene for cancer immunotherapy was patented by Therapeutic Solutions International in 20173, subsequent to which, numerous independent groups have shown the ability of this compound to block prostate4, breast5, melanoma6, glioma7, and lung cancers8. “This is a major step forward in Res Nova’s development plan for FloraStilbene™. These data, combined with existing preclinical and animal studies will serve as the basis for future clinical trials which will provide the basis for FDA sales approval,” said Dr. James Veltmeyer, Chief Medical Officer and the Physician who administered the drug. “From an ethical perspective, we are proud to have the support of several major leaders of the Pro-Life Movement including Bishop Joseph L Coffey (of the Military Archdiocese)9 and Dr. George Delgado (Inventor of the Abortion Pill Reversal) who sit on the Company’s Advisory Board10.” “The brilliant founders of Res Nova, with a miraculous stroke of genius, are turning a drug that destroys life into a 'weapon' that destroys cancer to saves lives,” said Deacon Keith Esshaki, Member of the Company’s Advisory Board. “The rapid translation of FloraStilbene™ from a laboratory discovery to a compounded drug speaks volumes to the power of the team that Ms Ramos has assembled,” said Timothy Dixon, President and CEO of Therapeutic Solutions International. “Through leveraging relationships and resources provided by TSOI, we anticipate accelerated availability of FloraStilbene™ to the multitude of drug resistant cancer patients.” “Breast cancer is a major epidemic for which novel treatments and research directions are urgently needed. We are thankful to our colleagues but most importantly to the brave patients who participated in this study, which we anticipate will be the foundation for a paradigm shifting approach to this dreadful disease,” said Famela Ramos, President and CEO of Res Nova Bio, Inc. About Therapeutic Solutions International, Inc. Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is . 1 Therapeutic Solutions International Spin-Off Res Nova Bio Partners with Cure Stat Rx to Manufacture First in Class Breast Cancer Immunotherapy Product FloraStilbene™ (yahoo.com) 2 Therapeutic Solutions International Subsidiary Res Nova Bio Inc Discovers New Mechanism of Action for Breast Cancer Immunotherapy Adjuvant FloraStilbene™ | BioSpace 3 US9682047B2 - Augmentation of oncology immunotherapies by pterostilbene containing compositions - Google Patents 4 Inhibition of miR-20a by pterostilbene facilitates prostate cancer cells killed by NK cells via up-regulation of NKG2D ligands and TGF-β1down-regulation: Heliyon 5 Differential Anticancer Activity of Pterostilbene Against Three Subtypes of Human Breast Cancer Cells | Anticancer Research (iiarjournals.org) 6 Pterostilbene supresses inflammation-induced melanoma metastasis by impeding neutrophil elastase-mediated thrombospondin-1 degradation – ScienceDirect 7 Pterostilbene promotes mitochondrial apoptosis and inhibits proliferation in glioma cells | Scientific Reports (nature.com) 8 Pterostilbene exerts anticancer activity on non-small-cell lung cancer via activating endoplasmic reticulum stress | Scientific Reports (nature.com) 9 Bishop Coffey - Archdiocese for the Military, USAArchdiocese for the Military, USA (milarch.org) 10 Res Nova Biologics Recruits Abortion Pill Reversal Founder to Scientific Advisory Board (yahoo.com)

Immunotherapy

20 Oct 2023

·www.biospace.com

Res Nova Biologics Announces First Cancer Patient Treated with FloraStilbene™

Therapeutic Solutions International Immuno-Oncology Subsidiary Makes Abortion Pill-Based Drug Available by Prescription through Cure Stat Rx Compounding Pharmacy ELK CITY, Idaho--(BUSINESS WIRE)-- Therapeutic Solutions International, Inc. (TSOI), announced today the successful first treatment of a patient with FloraStilbene™, a patent pending formulation of the abortion pill’s active ingredient, RU486, and pterostilbene. The Company has been utilizing pterostilbene, a naturally occurring analog of resveratrol, found in blueberries, for the treatment of cancer and immune modulation for several years, including being granted a patent on synergies with conventional immunotherapies1. In May of this year, Res Nova signed a collaborative agreement with compounding pharmacy Cure Stat Rx for developing a compounded formulation of FloraStilbene™2. “I have worked with Dr. Ramesh Chigurupati, President, and CEO of Cure Stat Rx for many years and have always been impressed by the efficiency and excellence in ability to provide compounded drugs and formulations,” said Dr. James Veltmeyer, Chief Medical Officer of Res Nova Bio. “We look forward to offering FloraStilbene™ to all patients taking immunotherapy, chemotherapy, or radiation therapy that can benefit from immune stimulation of NK cells, T cells, and dendritic cells.” FloraStilbene™ has previously been shown to enhance immunotherapy of various tumors3, as well as chemotherapy efficacy4. “The strategic objective of Therapeutic Solutions International is to develop intellectual property, use it to seed a subsidiary company, and let the subsidiaries grow and flourish,” stated Timothy Dixon, President, and CEO of Therapeutic Solutions International. “I am extremely proud of the leadership role of Ms. Ramos who in the period of less than a year was able to take FloraStilbene™ from concept to patient. This is literally unheard of in traditional biotechnology development models.” In addition to Res Nova, Therapeutic Solutions International has multiple subsidiaries including a) Campbell Neurosciences, focused on the identification of suicidal propensities using a proprietary test and various interventions5; b) Breath Biologics, which is in discussions with the FDA for its filed Phase I/II trial in COPD6; c) CTE Biologics, which is advancing its clinical stage technology for treating Chronic Traumatic Encephalopathy7; and d) VasoSome Vascular, which is in preclinical development of mesenchymal stem cell derived exosomes for treatment of aortic aneurysms8. “I am thankful for our translational medicine team that has worked closely with Drs Veltmeyer and Chigurupati for making this first patient treatment a reality,” said Famela Ramos, President, and CEO of Res Nova Bio. “Although we plan on performing clinical trials to formally establish a level of efficacy, we believe it is imperative to get this drug into the hands of physicians as soon as possible, and we are thankful for having the opportunity to do this today.” About Therapeutic Solutions International, Inc. Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is . 1 US9682047B2 - Augmentation of oncology immunotherapies by pterostilbene containing compositions - Google Patents 2 Therapeutic Solutions International Spin-Off Res Nova Bio Partners with Cure Stat Rx to Manufacture First in Class Breast Cancer Immunotherapy Product FloraStilbene™ | Business Wire 3 Novel Mechanism of Action of FloraStilbene Suggests Potential for Enhancing Efficacy of Checkpoint Inhibitor, CAR-T Therapies (pharmacytimes.com) 4 FloraStilbene™ Demonstrates Synergy with Conventional Chemotherapy and Immunotherapy in Reducing Triple Negative Breast Cancer | BioSpace 5 Therapeutic Solutions International Spin-Off Campbell Neurosciences Provides Progress Update in Quest for Addressing Suicide as a Medical Condition | Business Wire 6 Spinoff Breathe Biologics to Lead TSOI's Stem Cell Therapy Research | COPD News Today 7 Therapeutic Solutions International Launches Subsidiary Company to Commercialize Clinical Data and IND for Treatment of Chronic Traumatic Encephalopathy (CTE) with JadiCell Universal Adult Stem Cells | Business Wire 8 Therapeutic Solutions Launches VasoSome Vascular Inc. to Commercialize Aortic Aneurysm Treatment - Endovascular Today (evtoday.com)

ImmunotherapyClinical Study

21 Aug 2023

·www.biospace.com

FloraStilbene™ Demonstrates Synergy with Conventional Chemotherapy and Immunotherapy in Reducing Triple Negative Breast Cancer

Res Nova Bio Reports Landmark Oncology Findings Supporting Clinical Translation of its Pterostilbene-Abortion Pill Cancer Adjuvant ELK CITY, Idaho--(BUSINESS WIRE)-- Therapeutic Solutions International, Inc. (TSOI) reported that its breast cancer immunotherapy spin-off company, Res Nova Bio, released data showing synergistic suppression of breast cancer growth when used in combination with anti-PD1 and anti-CTLA4 antibodies, which represent clinically used checkpoint inhibitors such as Keytruda and Yervoy, respectively. Additionally, the Company demonstrated that FloraStilbene™ administration increased efficacy of the standard chemotherapies Taxotere and Cytotoxan which are used in breast cancer. The data were filed in a patent application covering adjuvant use of FloraStilbene™ in radiotherapy, oncolytic virus therapy, adoptive cellular therapy, chimeric antigen receptor therapy, chemotherapy and immunotherapy. “I have witnessed first-hand the devastating suffering, both mental and physical, that patients with advanced breast cancer go through,” said Dr. James Veltmeyer, Chief Medical Officer of the Company. “The findings announced today are a major accomplishment in our development of non-toxic immunotherapies of breast cancer. By leveraging similarities between pregnancy and cancer we have successfully been able to turn the abortion pill, a drug associated with death, into something that potentially saves lives.” Studies have shown that the abortion pill reduces activity of the cytokine TGF-beta1,2, which is involved in protecting the fetus from the maternal immune response, as well as protecting cancer cells from immunity of the body3. At a cellular level immature dendritic cells, which are found in both cancer and pregnancy seem to be stimulated to maturation by treatment with the abortion pill4. “I congratulate Ms. Famela Ramos and her team who has already initiated treating advanced breast cancer patients with ValloVax and is now rapidly racing towards the clinic with FloraStilbene™,” said Timothy Dixon, President, and CEO of Therapeutic Solutions International. “The fact that Res Nova already has secured a manufacturing and distribution partner for FloraStilbene™, Cure Stat5 supports our hope of rapidly entering the clinic and perhaps even accelerated sales through a 505b2 mechanism.” “At Res Nova Bio we are fixated on providing hope for patients who currently have very limited hope,” said Famela Ramos, President, and CEO of Res Nova Bio. “Knowing the detailed mechanisms of action of our products ensures not only solid intellectual property protection but also respect and credibility of potential acquisition partners and regulators. I am thankful to our scientific team and collaborators for their unceasing dedication to patients and shareholders.” About Therapeutic Solutions International, Inc. Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is . 1 Rearte et al. Mifepristone (RU486) restores humoral and T cell-mediated immune response in endotoxin immunosuppressed mice. Clin Exp Immunol. 2010 Dec; 162(3): 568–577. 2 Li et al. Mifepristone regulates Tregs function mediated by dendritic cells through suppressing the expression of TGF-β. Immunopharmacol Immunotoxicol . 2021 Feb;43(1):85-93. 3 Latifi et al. Dual role of TGF-β in early pregnancy: clues from tumor progression. Biol Reprod. 2019 Jun 1;100(6):1417-1430. 4 Xia et al. Dexamethasone enhances CTLA-4 expression during T cell activation. Cell Mol Life Sci. 1999 Sep;55(12):1649-56. 5 Therapeutic Solutions International Spin-Off Res Nova Bio Partners with Cure Stat Rx to Manufacture First in Class Breast Cancer Immunotherapy Product FloraStilbene™ | BioSpace

Immunotherapy

100 Deals associated with Pterostilbene

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Endometrioid intraepithelial neoplasia	Phase 2	United States	City of Hope National Medical Center	21 Jan 2019
Cystitis, Interstitial	Preclinical	China	Beijing Hospital of the Ministry of Health	08 Jun 2025
Cystitis, Interstitial	Preclinical	China	Peking University	08 Jun 2025
Neurodegenerative Diseases	Preclinical	Netherlands	APeT Holding B.V.	14 Mar 2022
Acute Myeloid Leukemia	Preclinical	Canada	University of British Columbia	01 Jul 2021
Prostatic Cancer	Preclinical	United States	Long Island University	15 Aug 2020
Renal fibrosis	Preclinical	China	West China Hospital	26 May 2017
Multiple Myeloma	Preclinical	United States	Institute for Myeloma & Bone Cancer Research	20 Nov 2009

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03671811 (CTgov)	Phase 2	Endometrioid intraepithelial neoplasia	44	megestrol acetate+Pterostilbene (Arm I (Pterostilbene, Megestrol Acetate))	plkfrbyrox(hsmfhqtqqb) = euhedfouvg cjofkhvkcg (cnvdiorqhn, 34.1) View more	-	06 Jan 2026
				megestrol acetate (Arm II (Megestrol Acetate))	plkfrbyrox(hsmfhqtqqb) = plkpwysllg cjofkhvkcg (cnvdiorqhn, 36.3) View more
NCT03671811 (ASCO2023)	Phase 2	Endometrial Carcinoma	44	Megestrol acetate + Pterostilbene	fnsvocnjsi(rjatbylddk) = nqeiqqsjxj msvlarsjtk (mxxberlhli )	Positive	31 May 2023
				Megestrol acetate	fnsvocnjsi(rjatbylddk) = sicwhzmuct msvlarsjtk (mxxberlhli )

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