magnesium hydroxide
Approved
Oct 16, 2000
Magnesium hydroxide is an inorganic compound with the chemical formula Mg(OH)2. It occurs in nature as the mineral brucite. It is a white solid with low solubility in water (Ksp = 5.61×10−12). Magnesium hydroxide is a common component of antacids, such as milk of magnesia. — Wikipedia
Clinical trial activity
21 trials · 39 clinical orgs · 3 marketing orgs
Earliest trial started Apr 1, 2007 (NCT00446316)
Timeline
2000s
- Oct 16, 2000
Johnson and Johnson — Earliest FDA Approval
- Oct 16, 2000
Johnson and Johnson — NDA Secondary Org
- Oct 16, 2000
Johnson and Johnson — NDA Organization
- Mar 24, 2006
Santarus — NDA Secondary Org
- Jan 1, 2007
Earliest Phase 1 Sponsor(trial)
- Feb 6, 2008
Perrigo — Marketing Organization
- Jan 1, 2009
Earliest Phase 2 Sponsor(trial)
2010s
- Jan 1, 2011
Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Unspecified targetOTHER
Saline laxative
- magnesiumSupplementation
magnesium supplementation
Combination products
pepcid complete
with calcium carbonate, famotidine
Approval history
- approvedOct 16, 2000
Chemistry & pharmacology
SMILES
[Mg+2].[OH-].[OH-]- Mol. weight
- 58.32 g/mol
- Chirality
- Achiral Molecule
- Inorganic
- Yes
- Polymer
- No
- Delivery
- Oral
- Availability
- Over the Counter
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaMagnesium hydroxide ↗
- ChEMBLCHEMBL1200718 ↗
Also known as
- cremaffin
- crm of magnesia
- e528
- e528
- hydro-magna
- magnalax
- magnesia magma
- magnesia magma
- magnesia, [milk of]
- magnesia, [milk of]
- magnesium dihydroxide
- magnesium dihydroxide
- magnesium hydroxide
- magnesium hydroxide
- magnesium hydroxide
- magnesium hydroxide
- magnesium hydroxide
- magnesium hydroxide
- magnesium hydroxide
- magnesium hydroxide
- magnesium hydroxide
- magnesium hydroxide
- milk of magnesia
- milk of magnesia
- milk of magnesia
- milk of magnesia
- milk of magnesia
- mil-par
- mint-o-mag
- mint-o-mag
- mintox
- oxaine m
- oxaine m
- phillips magnesia tablets
- phillips magnesia tablets
- phillips milk of magnesia
- phillips milk of magnesia liquid
- phillips milk of magnesia liquid
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07235878 | N/A | Nov 17, 2025 | Northumbria University, Vitabiotics |
| NCT05216328 | Phase 3 | Dec 2, 2022 | Erasmus University Rotterdam, Flevoziekenhuis, Free University of Amsterdam, Jeroen Bosch Ziekenhuis, Leiden University, Radboud University, Rijnstate Hospital, Spaarne Gasthuis, University of Groningen, Utrecht University |
| NCT04802785 | Phase 2/Phase 3 (Phase 3) | Jun 30, 2021 | lurye Clinic |
| NCT04368585 | Phase 1 | May 31, 2020 | Spero Therapeutics |
| NCT04269356 | Phase 1 | Feb 14, 2020 | Bristol-Myers Squibb |
| NCT05109390 | Phase 1 | Jul 27, 2018 | Alexion |
| NCT03490396 | Phase 4 | May 15, 2018 | Midatech Pharma, PharPoint Research, Inc. |
| NCT01982201 | Phase 1 | Nov 1, 2013 | Ardea Biosciences |
| NCT01773096 | Phase 4 | May 1, 2013 | Shriners Hospitals for Children |
| NCT01691742 | N/A | Sep 1, 2012 | American Urogynecologic Society, Duke University |
| NCT01622673 | Phase 1 | Jun 1, 2012 | Merck |
| NCT01336530 | Phase 3 | Apr 1, 2011 | Clinipace LTD, Gottfried Wilhelm Leibniz Universität Hannover, ICON, Meda, Trium Analysis Online GmbH |
| NCT01291030 | N/A | Jan 1, 2011 | Astellas, Ghent University |
| NCT01281501 | Phase 4 | Jan 1, 2011 | Chulalongkorn University |
| NCT01118936 | N/A | Oct 1, 2010 | Aarhus University, Gunnar Kjems APS |
| NCT01118923 | N/A | Oct 1, 2010 | Aarhus University, Gunnar Kjems APS |
| NCT01156129 | Phase 1 | Sep 1, 2010 | University of Nebraska |
| NCT01037452 | Phase 2 | Dec 1, 2009 | Novartis |
| NCT00858455 | Phase 1 | Jan 1, 2009 | GlaxoSmithKline, Shionogi |
| NCT00944671 | Phase 1 | Feb 1, 2008 | Johnson and Johnson, Merck |
Organizations
Research & Development (39)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Aarhus University | Academic/Hospital | 2 | 2 | 1 | 2010 |
| Gunnar Kjems APS | Academic/Hospital | 2 | 0 | 1 | 2010 |
| Merck | For profit | 2 | 1 | 1 | 2008 |
| Novartis | For profit | 2 | 1 | 2 | 2007 |
| Alexion | For profit | 1 | 1 | 1 | 2018 |
| American Urogynecologic Society | Academic/Hospital | 1 | 0 | 1 | 2012 |
| Ardea Biosciences | For profit | 1 | 1 | 1 | 2013 |
| Astellas | For profit | 1 | 0 | 1 | 2011 |
| Bristol-Myers Squibb | For profit | 1 | 1 | 1 | 2020 |
| Chulalongkorn University | Academic/Hospital | 1 | 1 | 1 | 2011 |
| Clinipace LTD | For profit | 1 | 0 | 1 | 2011 |
| Duke University | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Erasmus University Rotterdam | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Flevoziekenhuis | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Free University of Amsterdam | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Ghent University | Academic/Hospital | 1 | 1 | 1 | 2011 |
| GlaxoSmithKline | For profit | 1 | 1 | 1 | 2009 |
| Gottfried Wilhelm Leibniz Universität Hannover | Academic/Hospital | 1 | 0 | 1 | 2011 |
| ICON | For profit | 1 | 0 | 1 | 2011 |
| Jeroen Bosch Ziekenhuis | Academic/Hospital | 1 | 0 | 1 | 2022 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Johnson and Johnson | For profit | NDA2 | Oct 16, 2000 |
| Johnson and Johnson | For profit | NDA | Oct 16, 2000 |
| Perrigo | For profit | MKTG | Feb 6, 2008 |
| Santarus | For profit | NDA2 | Mar 24, 2006 |