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.
November, 2024 – Gateway Pharma completed clinical batch manufacturing of Metronidazole 505(b)(2) product for Phase 1 study.
July, 2023 – Gateway Pharma raised $300K co-development funds to move Metronidazole 505(b)(2) product forward into Phase 1 clinical study.
September, 2020 – Gateway is working with the NIH NIAID on GMP manufacturing of Metronidazole 505(b)(2) product for treating Clostridium difficile Infection.
March, 2020 – Our key colon-delivery patent 10,588,864 received approval from the US PTO.
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.
August, 2018 – Received the NIH SBIR Phase I grant on Metronidazole Colon-Delivery for treating Clostridium difficile Infection.
June, 2018 – Developed Buoy re-hydration dietary supplement for Better Tomorrow, and launched on the US market.
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.