Ketotifen and Indomethacin Combination Treatment Clinical Trial for COVID-19 A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Proof-of-Concept Clinical Trial to Evaluate the Efficacy of Ketotifen and Indomethacin for Mild and Moderate COVID-19 in Adults

The purpose of this study is to evaluate the safety and effectiveness of ketotifen and indomethacin taken together to improve symptoms related with COVID-19. Ketotifen and indomethacin are medications approved by the Food and Drug Administration (FDA) to treat diseases other than COVID-19. Their use in this study is investigational, meaning they have not been approved by the FDA to treat COVID-19.

Start Date03 May 2022

Sponsor / Collaborator

Sen-Jam Pharmaceutical LLCStartup

[+1]

NCT03183297

/ Unknown statusPhase 1

A Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Pharmacokinetics and Pharmacodynamics at Two Dose Levels of JMI-001 in Comparison With Fexofenadine and Naproxen Administered in Conjunction With Alcohol.

This will be a double-blind, placebo-controlled study with a 4-way crossover design with subjects administered study drug (JMI-001), placebo, fexofenadine alone and naproxen alone on different study days, in conjunction with a quantity of alcohol estimated to be sufficient to produce a hangover the next day. The primary objective of the study is the evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of two different doses of JMI-001 administered in conjunction with alcohol to healthy adult subjects.

Start Date01 Aug 2017

Sponsor / Collaborator

Sen-Jam Pharmaceutical LLCStartup

NCT02737397

/ CompletedPhase 2

A Double-blind Placebo-controlled 4-Way Crossover Study to Evaluate the Efficacy of JMI-001 (an Over-the-counter Pain Medicine and an Antihistamine) in the Prophylaxis of Veisalgia in Healthy Volunteers

The purpose of this study is to determine the safety and efficacy of a combination product for the prevention of veisalgia. Common symptoms of veisalgia following the moderate consumption of alcohol includes headache, fatigue, and thirst. It is the investigators hypothesis that a combination of two drugs can alleviate or significantly reduce these symptoms when taken before the start of moderate alcohol consumption.

Start Date01 Mar 2016

Sponsor / Collaborator

Sen-Jam Pharmaceutical LLCStartup

100 Clinical Results associated with Sen-Jam Pharmaceutical LLC

0 Patents (Medical) associated with Sen-Jam Pharmaceutical LLC

Literatures (Medical) associated with Sen-Jam Pharmaceutical LLC

01 Jun 2021·PsychopharmacologyQ3 · MEDICINE

Functional observation after morphine withdrawal: effects of SJP-005

Q3 · MEDICINE

Article

Author: Dahl, Thomas A ; Verster, Joris C ; Iversen, Jacqueline M ; Scholey, Andrew

Abstract:

Rationale and objective:

SJP-005 (ketotifen and ibuprofen) is being developed as a potential new treatment for opioid withdrawal. Three studies were conducted to evaluate the early phase (acute, day 1) and late phase (days 2–12) effects of SJP-005 on discontinuation-induced morphine withdrawal.

Methods:

Sprague-Dawley rats received subcutaneous morphine twice daily for 18 days and ceased on day 19. Twice daily, oral dosages of placebo or SJP-005 (1 mg/kg ketotifen and 15 mg/kg ibuprofen) were administered starting 4 days before (study 1), 2 days before (study 2), or immediately after (study 3) morphine cessation. Functional observations were made up to 12 h after treatment cessation on day 19 (early phase), and immediately after treatment on days 20–30 (late phase). Treatment effects (mean overall score, and individual symptoms) were compared with placebo using ANOVA, and Tukey’s tests in case of multiple comparisons.

Results:

Across the studies, the number of withdrawal signs on day 19 (early phase) and days 20–30 (late phase) was lower with SJP-005 compared with placebo. The effects of SJP-005 when treatment was initiated 2 days before morphine cessation by discontinuation were most pronounced and statistically significant in the late phase (F(1,18) = 14.10, p = 0.001). In particular, a significant reduction was observed in hypersensitivity to touch (F(1,18) = 13.65, p = 0.002). A 50% reduction in withdrawal symptoms was observed 9.0 days after placebo versus 4.5 days after SJP-005. After 9.0 days, all withdrawal symptoms were absent in the SJP-005 group, while symptoms in the placebo group were still evident on day 18.

Conclusion:

Compared to placebo, SJP-005 significantly reduced the incidence and duration of discontinuation-induced morphine withdrawal symptoms when treatment was initiated 2 days before morphine cessation.

11 Jun 2018·Current drug abuse reviews

Proceeding of the 9th Alcohol Hangover Research Group Meeting

Author: van Schrojenstein Lantman, Marith ; Gunn, Craig ; Adams, Sally ; Merlo, Agnese ; Mackus, Marlou ; Verster, Joris C ; Wilod Versprille, Livia J F ; Scholey, Andrew ; Iversen, Jacqueline ; Devenney, Lydia ; Benson, Sarah ; Johnson, Sean J ; van de Loo, Aurora J A E ; Stock, Ann-Katrin

BACKGROUND:

Alcohol hangover is a common occurrence among individuals who have experienced an episode of heavy alcohol consumption the previous night. Until now defined as the general feeling of misery that develops once the Blood Alcohol Concentration approaches zero. Despite its prevalence and several related adverse consequences, insufficient research has been conducted with regards to this matter and further understanding of the pathology of alcohol hangover is necessary. During the 9th Alcohol Hangover Research Group meeting, held on April 29th 2017, Utrecht, The Netherlands, numerous aspects of alcohol hangover were presented and many advances with regards to determinants, biological and cognitive consequences and potential treatment have been presented.

CONCLUSION:

Precisely, a definition of alcohol hangover has been established and wider understandings of biological and cognitive effects, alcohol metabolism, immune functioning and potential treatment of alcohol hangover were presented and discussed. Further research and development are necessary to attain a wider understanding of the pathology of alcohol hangover.

Journal of clinical medicineQ3 · MEDICINE

The Effects of SJP-001 on Alcohol Hangover Severity: A Pilot Study

Q3 · MEDICINE

ArticleOA

Author: Verster, Joris C ; Iversen, Jacqueline M ; Dahl, Thomas A ; Scholey, Andrew

Background. Despite a clear market need and many hangover products available, currently there is no hangover treatment that is supported by substantial scientific evidence demonstrating its efficacy and safety. A pilot study was conducted to investigate the effects of a potential new hangover treatment, SJP-001, and its constituents (220 mg naproxen and 60 mg fexofenadine) on hangover severity. Methods. N = 13 healthy social drinkers (36.3 ± 8.9 years old) participated in a double-blind, factorial design, cross-over study. On each test day, they consumed their own choice of alcohol up to a self-reported level sufficient to elicit a next-day hangover. Treatments were administered prior to onset of drinking. Next morning, hangover severity was assessed with the Acute Hangover Scale (AHS). Subjects were included in the efficacy analysis only if they reported a hangover after placebo. Results. N = 5 subjects (60% male, 35.2 ± 9.0 years old) were included in the analysis. They consumed a mean (SD) of 4.6 ± 1.1 units of alcohol and had an average peak breath alcohol concentration (BrAC) of 0.065% across conditions. Compared to placebo, SJP-001 significantly improved the AHS overall hangover severity score (0.8 ± 0.3 versus 1.5 ± 0.9, p = 0.042). Compared to placebo, SJP-001 also reduced scores on the individual item ‘hangover’, although the observed improvement (−1.6) did not reach statistical significance (p = 0.102). The differences from placebo after naproxen alone and fexofenadine alone were not statistically significant. SJP-001 also improved scores for the individual hangover symptoms tired, thirsty, headache, dizziness, nausea, and loss of appetite, but these effects did not reach statistical significance. Discussion. Compared to placebo, SJP-001 significantly reduced overall hangover severity. The effects of SJP-001 should be further examined in a double-blind, placebo-controlled trial with a larger sample size and controlled administration of sufficient amounts of alcohol to provoke a more substantial alcohol hangover.

News (Medical) associated with Sen-Jam Pharmaceutical LLC

10 Feb 2025

·www.prnewswire.com

Sen-Jam Pharmaceutical Engages Destum Partners to Source Strategic Partnerships for SJP-001 & SJP-002C

HUNTINGTON, N.Y., Feb. 10, 2025 /PRNewswire/ -- Sen-Jam Pharmaceutical, a pioneering biotech company dedicated to innovative anti-inflammatory solutions, is pleased to announce its engagement with Destum Partners, a leading advisory firm specializing in biopharma transactions. This strategic collaboration will focus on securing licensing, co-development, and potential M&A opportunities for Sen-Jam's two lead assets, SJP-001 (Overindulgence of Food and Alcohol) and SJP-002C (COVID-19/Upper Respiratory Infections). Strategic Growth Through Partnerships This engagement with Destum Partners aligns with Sen-Jam's mission to bring groundbreaking treatments to market while maximizing shareholder value. Key objectives of the collaboration include: Identifying and securing strategic licensing and co-development partners to accelerate commercialization. Leveraging Destum Partners' extensive industry network across Big Pharma, mid-sized biotech, and consumer health companies. Exploring potential M&A transactions to enhance company growth and investor returns. Executing a structured transaction process, including outreach, due diligence, valuation modeling, term-sheet negotiations, and deal closure. Investor Benefits: Fractional Royalty Rights (FRR) on SJP-001 A critical component of this initiative is its direct impact on Sen-Jam's Fractional Royalty Right (FRR) program. Investors participating in the FRR program stand to benefit from licensing revenue generated by SJP-001. A successful licensing agreement would initiate royalty-based revenue streams, with the first investor royalty distributions targeted within 6-12 months post-licensing. This structured approach ensures tangible financial benefits for FRR holders, tying investment success to Sen-Jam's commercial achievements. Why Destum Partners? Destum Partners brings an impressive track record of over $5.0 billion in completed transactions and 80+ years of combined experience in pharmaceutical and healthcare deal-making. Their expertise in valuation modeling, strategic advisory services, and transaction execution will be instrumental in securing optimal partnerships for SJP-001 and SJP-002C. "We are thrilled to be partnering with Sen-Jam Pharmaceutical at such a pivotal moment in their journey," said Matt Vanderberg, Managing Director & Partner at Destum Partners. "Their innovative approach to inflammation management has the potential to redefine patient care, and we look forward to leveraging our expertise to secure the right partners to bring these groundbreaking therapeutics to market." Next Steps & Strategic Milestones Destum Partners has already initiated a formal transaction process, beginning with the completion of the Market Analysis and Valuation for SJP-001 and SJP-002C in 2024. Key upcoming milestones include: BIO-Europe Spring – March 2025 (Milan) BIO International – June 2025 (Boston) BIO-Europe Fall – November 2025 (Vienna) These events, coupled with Destum Partners' extensive industry network, provide vital opportunities for discussions, due diligence, and negotiations with potential strategic partners. Maximizing Investor Value & Commercial Impact This partnership underscores Sen-Jam's commitment to delivering long-term shareholder value by advancing SJP-001 and SJP-002C toward commercialization through strategic collaborations. By engaging Destum Partners, Sen-Jam is accelerating its path to market, unlocking new revenue opportunities, and positioning itself as a leader in the next generation of anti-inflammatory therapeutics. Sen-Jam Pharmaceutical will continue to update stakeholders as discussions progress, milestones are achieved, and pivotal licensing opportunities materialize. With each strategic step, the company solidifies its trajectory toward market success and capital return to investors. "We are ecstatic to see our therapeutics moving closer to commercialization, and to create significant value for our investors and the broader healthcare community," said Jim Iversen, Co-Founder/CEO at Sen-Jam Pharmaceutical. About Sen-Jam Pharmaceutical Sen-Jam Pharmaceutical is committed to revolutionizing inflammation treatment with its Pleiotropic Anti-Inflammatory Remedies (PAIR) technology, targeting mast cell modulation for superior patient outcomes. Sen-Jam delivers precision therapies that work in harmony with the body's immune system to mitigate systemic risks associated with chronic inflammation while supporting long-term health and vitality. Sen-Jam aims to disrupt traditional approaches to inflammation management and redefine pharmaceutical care. To learn more visit wefunder.com/senjam. About Destum Partners Destum Partners is a premier life sciences advisory firm specializing in M&A, licensing, and strategic partnerships. With extensive expertise in biopharma deal-making, Destum Partners supports companies in achieving transformative growth through strategic transactions. CONTACT INFORMATION: Sen-Jam Pharmaceutical Christine Leonard [email protected] 781-913-1902 SOURCE Sen-Jam Pharmaceutical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/in

27 Jan 2025

·www.prnewswire.com

Sen-Jam Pharmaceutical Answers Surgeon General's Alarm with a New Therapeutic Aimed at Tackling Alcohol Related Risks

HUNTINGTON, N.Y., Jan. 27, 2025 /PRNewswire/ -- A newly published paper in the Global Journal of Addiction & Rehabilitation Medicine further expands on the U.S. Surgeon General's advisory, linking frequent alcohol consumption and hangovers to chronic systemic inflammation and heightened cancer risk. Fortunately, Sen-Jam Pharmaceutical's innovative therapeutic, SJP-001, is specifically designed to target this inflammatory pathway, offering a groundbreaking solution to mitigate alcohol-induced health risks. Continue Reading Sen-Jam Pharmaceutical "The Surgeon General's advisory highlights inflammation as a mechanism linking alcohol consumption to cancer formation, a connection aligned with our research," said Jacqueline Iversen, RPh, MS, Founder and CCO of Sen-Jam Pharmaceutical. "Our therapeutic under development, SJP-001, is designed to intervene in this inflammatory process, reducing both immediate effects like hangovers and long-term health risks. This would be a significant step forward in reducing disease burden to the millions of people who enjoy consuming alcohol." The paper, published on the heels of the Surgeon General's advisory, underscores that frequent hangovers can lead to chronic systemic inflammation, a major risk factor for developing cancers and other diseases. SJP-001 directly targets this inflammatory cascade, providing dual-action benefits: immediate relief from hangover symptoms and potential long-term reduction of systemic chronic inflammation. "Sen-Jam's research represents a major advancement in understanding and potentially mitigating alcohol-related risks," said Joris Verster, PhD, Sen-Jam Scientific Advisor and lead author of the newly published paper. "Our findings support the development of innovative therapies like SJP-001, which not only address the immediate symptoms of alcohol hangover but also target the root causes of chronic inflammation." Early clinical data from testing SJP-001, a novel combination of two pharmaceutical agents, revealed significant reductions in hangover severity. A larger double-blind, placebo-controlled trial is currently underway with Novotech, a global full-service clinical Contract Research Organization (CRO). Beyond immediate symptom relief, the therapeutic potential to address chronic inflammation positions it as a breakthrough in mitigating long-term health risks associated with alcohol consumption. The market potential for SJP-001 is substantial. The global hangover remedy market was valued at $2.34 billion in 2023 and is projected to grow to over $6 billion by 2030 at a compound annual growth rate (CAGR) of 14.9%. According to Destum Partners' - Market Analysis & Valuation, SJP-001's current projected valuation of $107 million in the U.S. and Europe is anticipated to surge to $688 million by 2027, fueled by the successful completion of clinical trials and securing commercial approval. These projections underscore the economic and societal value of bringing the first FDA-approved, scientifically validated hangover remedy to market. "Our mission is to develop safe, effective solutions for the millions impacted by alcohol-induced inflammation," said Jim Iversen, CEO of Sen-Jam Pharmaceutical. "The Surgeon General's advisory reinforces the importance of innovations like SJP-001 to address both immediate and long-term health risks." To learn more about Sen-Jam Pharmaceutical and SJP-001, visit . About Sen-Jam Pharmaceutical Sen-Jam Pharmaceutical is a pioneering biotech company transforming the treatment landscape for inflammation and metabolic disorders. Through its proprietary "Pleiotropic Anti-Inflammatory Remedies" (PAIR) technology, Sen-Jam delivers precision therapies that work in harmony with the body's immune system to mitigate systemic risks associated with chronic inflammation while supporting long-term health and vitality. To learn more visit wefunder.com/senjam. CONTACT INFORMATION: Sen-Jam Pharmaceutical Christine Leonard [email protected] 781-913-1902 SOURCE Sen-Jam Pharmaceutical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

10 Jan 2025

·www.prnewswire.com

Sen-Jam Pharmaceutical Announces Planned AI Initiative for Molecule Repurposing

HUNTINGTON, N.Y., Jan. 10, 2025 /PRNewswire/ -- Sen-Jam Pharmaceutical ("Sen-Jam"), a pioneer in innovative inflammatory care, today announced a planned new initiative for use of leading-edge AI tools to accelerate the discovery and development of repurposed molecular combinations. This forward-thinking approach, combined with Sen-Jam's proprietary "Pleiotropic Anti-Inflammatory Remedies" (or "PAIR") technology, is expected to enable the rapid identification and optimization of therapeutic candidates—shortening development timelines and improving success rates for complex inflammatory conditions. In an industry where traditional drug development can take decades and cost billions, Sen-Jam's planned AI-driven approach to molecular repurposing is intended to represent a paradigm shift in pharmaceutical innovation. By leveraging artificial intelligence to analyze vast datasets of existing molecules, taking into consideration their mechanism of action and efficacy data as it relates to inflammatory driven disease, Sen-Jam hopes to be able to identify promising combinations that work synergistically with the body's natural inflammatory responses. By leveraging state-of-the-art AI tools, Sen-Jam plans to rapidly evaluate millions of potential molecular combinations, assessing their safety profiles, interaction patterns, and therapeutic promise. Early prototypes of this data-driven approach have already revealed several promising candidates in Sen-Jam's pipeline, suggesting its promise to streamline the development of safe, effective, and affordable treatments. "Our planned AI-driven approach to molecular repurposing isn't just about finding new uses for existing drugs – it's about understanding the complex interplay between inflammation and human health at a fundamental level," said Jim Iversen, Co-Founder and CEO of Sen-Jam Pharmaceutical. "By combining artificial intelligence with our PAIR technology, we plan to identify and optimize therapeutic combinations that work in harmony with the body's natural processes, potentially revolutionizing treatment options for millions of patients worldwide." Sen-Jam's planned integrated approach promises substantial advantages over traditional drug development strategies: Reduced candidate optimization timelines by up to 60% through AI-driven insights Lower overall costs via strategic repurposing Enhanced safety profiles by leveraging well-characterized molecules Improved success rates in clinical development Accelerated path to market through the 505(b)(2) pathway By leveraging advanced AI tools, Sen-Jam expects to excel at identifying molecular combinations that complement its proprietary PAIR technology—enabling precision therapies that target inflammation at its source without compromising immune system function. This approach may prove especially valuable in treating complex inflammatory conditions where traditional single-molecule strategies have come up short. "The future of pharmaceutical development lies in intelligent combination therapies that work with the body's natural processes," Iversen continued. "Our planned AI-driven approach to molecular repurposing, combined with our PAIR technology, will position us at the forefront of this revolution in therapeutic development. We're not just developing new treatments – we're hoping to redefine how modern medicines are discovered and developed." "The intersection of artificial intelligence and molecular repurposing represents one of the most promising frontiers in pharmaceutical innovation," added Dr. Alexander Wissner-Gross, Scientific Advisor to Sen-Jam Pharmaceutical. "Sen-Jam's plan to combine AI-driven insights with their PAIR technology platform has the potential to transform how new treatments for complex inflammatory conditions are identified." Sen-Jam is actively seeking strategic partnerships to leverage its platform across multiple therapeutic areas. The company's commitment to innovation in drug development represents a significant step forward in making effective treatments more accessible to patients worldwide. About Sen-Jam Pharmaceutical Sen-Jam Pharmaceutical ("Sen-Jam") is pioneering a revolutionary approach to inflammatory care with our proprietary "Pleiotropic Anti-Inflammatory Remedies" (or "PAIR") technology. By working with the body's innate immune system, its precision remedies modulate inflammation at its source, offering transformative solutions that reduce systemic risks without suppressing the immune system. Sen-Jam is leading the next evolution in healthcare, delivering innovative treatments that enhance vitality, extend health spans, and redefine how the world heals. CONTACT INFORMATION: Sen-Jam Pharmaceutical Christine Leonard [email protected] 781-913-1902 SOURCE Sen-Jam Pharmaceutical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 Deals associated with Sen-Jam Pharmaceutical LLC

100 Translational Medicine associated with Sen-Jam Pharmaceutical LLC

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Pipeline Snapshot as of 26 Apr 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Phase 1

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

SJP-005	Opioid-Related Disorders More	Phase 1
SJP-001	Hangover from alcohol More	Phase 1
lbuprofen/Ketotifen ( COXs x H1 receptor )	Pain More	Preclinical
SJP-101	Arthritis More	Preclinical
SJP-004 (Sen-Jam Pharmaceutica)	Arthritis More	Preclinical

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