Drugs / magnesium hydroxide

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) PEPCID COMPLETE 2000-10-16 fda.gov

Trials 7 · a red edge is where a trial was stopped

200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT04368585 Jul → Aug 2020 Spero Therapeutics Completed No outcome recorded
Phase 1 NCT04324905 Apr → Oct 2020 Hanmi Pharmaceutical Company Limited Completed No outcome recorded
Phase 1 NCT05109390 Jul → Oct 2018 Alexion Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT02382640 Mar → May 2015 Takeda Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT04382157 Feb 2020 → Aug 2022 magnesium deficiency Oslo University Hospital Unknown No outcome recorded
Phase 21 trial
Phase 2 NCT01037452 Dec 2009 → Jan 2010 dyspepsia Novartis Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04802785 Jun → Jul 2021 Dinara Zhumanbayeva Unknown No outcome recorded
Also used as a comparator or background therapy in 7 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT05028673 Background Aug → Dec 2021 H. Lundbeck A/S Completed No outcome recorded
Phase 22 trials
Phase 2 NCT06503978 Background Aug 2024 → Jul 2025 overdue autism spectrum disorder, constipation disorder, diarrheal disease Gut-Brain-Axis Therapeutics Inc. Active not recruiting No outcome recorded
Phase 2 NCT06321796 Background Feb 2024 → Feb 2025 Pitt-Hopkins syndrome Gut-Brain-Axis Therapeutics Inc. Unknown No outcome recorded
Phase 31 trial
Phase 3 NCT01336530 Comparator Apr 2011 → Jan 2017 radiation-induced disorder MEDA Pharma GmbH & Co. KG Terminated No outcome recorded
Phase 43 trials
Phase 4 NCT05216328 Comparator Dec 2022 → Dec 2025 overdue opioid-induced constipation Amsterdam UMC, location VUmc Recruiting No outcome recorded
Phase 4 NCT01773096 Background May 2013 → May 2015 constipation disorder Shriners Hospitals for Children Completed No outcome recorded
Phase 4 NCT01281501 Background Jan → Oct 2011 dyspepsia Chulalongkorn University Completed No outcome recorded

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 14 sources stand behind the page.

FieldValueCited text
Known as magnesium hydroxide “The fixed-dose combination of esomeprazole and magnesium hydroxide showed rapid absorption and quicker gastric acid suppression than enteric-coated esomeprazole with comparable...” PMID 39289057 Sep 2024
13

“Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent” NCT02382640

“Each 5 ml consists of Aluminum Hydroxide - 200 mg, Magnesium Hydroxide - 200 mg, and Simethicone - 20 mg.” NCT06503978

“Each 5 ml consists of Aluminum Hydroxide - 200 mg, Magnesium Hydroxide - 200 mg, and Simethicone - 20 mg.” NCT06321796

“30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide)” NCT01281501

“Aluminum hydroxide and magnesium hydroxideNCT05028673

“Slow-released magnesium hydroxideNCT04382157

NCT01037452

NCT01336530

NCT04368585

NCT05216328

NCT01773096

NCT04802785

NCT05109390

Route Oral “30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide)” NCT01281501