Company News
March, 2025 – Gateway Pharma received the FDA’s approval to proceed with the clinical investigation of the Phase 1 trial of Metronidazole Delayed-Release Capsules for treating Clostridioides difficile infection (CDI).
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November, 2024 – Gateway Pharma completed clinical batch manufacturing of Metronidazole 505(b)(2) product for Phase 1 study.
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July, 2023 – Gateway Pharma raised $300K co-development funds to move Metronidazole 505(b)(2) product forward into Phase 1 clinical study.
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September, 2020 – Gateway is working with the NIH NIAID on GMP manufacturing of Metronidazole 505(b)(2) product for treating Clostridium difficile Infection.
May, 2020 – Applied NIH NIAID grant on Metronidazole 505(b)(2) product Phase 1 human clinical study.
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March, 2020 – Our key colon-delivery patent 10,588,864 received approval from the US PTO.
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March, 2020 – Office response on China patent application CN107174572A entitled “Pharmaceutical Compositions for Colon-Specific Delivery”.
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​January, 2020 – Completed Type C meeting with the FDA on clinical study design of Metronidazole Delayed-Release Capsules.​
November, 2018 – Gateway won the BioSTL Award
on the 10th Startup Connection Venture Showcase
in St. Louis.
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August, 2018 – Received the NIH SBIR Phase I grant on Metronidazole Colon-Delivery for treating Clostridium difficile Infection.
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June, 2018 – Developed Buoy re-hydration dietary supplement for Better Tomorrow, and launched on the US market.
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February, 2018 – Received QIDP designation for Metronidazole 505(b)(2) product and additional
5-years of market exclusivity.
March, 2017 – Submitted Pre-IND package of Metronidzole 505(b)(2) product for treating Clostridium difficile Infection.
October, 2016 – Invited Speaker at "6th Annual Drug Delivery and Formulation Asia Summit" at Shanghai, China.
2015-2017 – Consulting services to Long Pharma
(Alkem Labs) on semi-solid product development including ointment, creams, and nasal sprays, and guided the company on five FDA submissions.
2012-2015 – Contract research services to DanSol Pharma, Princeton Pharma and PharmaMax on ANDA solid products including nanoparticle tablet, extended releases-tablets, bi-layer tablets and stability challenging delayed-release capsules.