Aluminum hydroxide
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | GAVISCON | — | 1983-12-09 | fda.gov ↗ |
Trials 28 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 33 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 123 trials | ||||||
| Phase 1 | NCT06613789 Background | Jul 2026 → Jun 2027 expected | HIV infectious disease | HIV Vaccine Trials Network | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05983874 Background | Apr 2024 → Mar 2025 | HIV infectious disease | International AIDS Vaccine Initiative | Unknown | No outcome recorded |
| Phase 1 | NCT05561673 Background | Oct 2022 → Nov 2024 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT04985760 Background | Sep 2021 → Jan 2026 | HIV infectious disease | Madhu Chhanda Choudhary | Completed | No outcome recorded |
| Phase 1 | NCT05028673 Background | Aug → Dec 2021 | — | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT03776994 Background | Jul 2018 → Jul 2020 | Venezuelan equine encephalitis, viral encephalitis | SRI International | Unknown | No outcome recorded |
| Phase 1 | NCT02647489 Background | May 2016 → Nov 2017 | malaria | University Hospital Tuebingen | Completed | No outcome recorded |
| Phase 1 | NCT02476773 Background | Jan 2016 → Jun 2017 | hookworm infectious disease | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT02450838 Background | Apr → Oct 2015 | dengue disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT02337855 Background | Feb 2015 → Jan 2017 | intestinal schistosomiasis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT01995617 Background | Nov 2013 → Feb 2015 | pneumococcal infection | Genocea Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01717950 Background | Sep 2013 → Jun 2015 | hookworm infectious disease | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT01477580 Background | Jul 2012 → Jan 2014 | dengue disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01385189 Background | May 2012 → Jan 2015 | hookworm infectious disease | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT00974935 Background | Feb 2011 → Mar 2015 | staphylococcal toxic-shock syndrome | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00936429 Background | Jul 2009 → Jul 2010 | dengue disease | Hawaii Biotech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00740090 Background | Aug 2008 → Jun 2009 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00427167 Background | Jan 2007 → Nov 2008 | malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00246467 Background | Oct 2005 → Apr 2007 | plague | PharmAthene UK Limited | Completed | No outcome recorded |
| Phase 1 | NCT00587249 Background | Jul 2002 → Jul 2005 | Plasmodium falciparum malaria | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00002402 Background | — | HIV infectious disease | VaxGen | Completed | No outcome recorded |
| Phase 1 | NCT00000809 Background | — | HIV infectious disease, seronegative autoimmune hepatitis | National Institute of Allergy and Infectious Diseases (NIAID) | Withdrawn | No outcome recorded |
| Phase 1 | NCT00000868 Background | ? → May 2000 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT03284710 Comparator | Jun 2017 → Dec 2019 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT01627678 Background | Sep 2012 → Nov 2013 | HIV infectious disease | Bionor Immuno AS | Completed | No outcome recorded |
| Phase 1/2 | NCT00984763 Background | Jan → Sep 2010 | malaria | University of Oxford | Completed | No outcome recorded |
| Phase 24 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 2 | NCT02153112 Background | Jun 2015 → Jun 2018 | norovirus infectious disease | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT02116998 Background | Sep 2014 → Apr 2016 | streptococcal pneumonia | Genocea Biosciences, Inc. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01281501 Background | Jan → Oct 2011 | dyspepsia | Chulalongkorn University | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05876195 Comparator | Mar → Oct 2023 | — | University of Oxford | Unknown | No outcome recorded |
| — | NCT00031109 Background | ? → May 2005 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 67 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | aluminum hydroxide | “The toxoids, either alone or in combination with aluminum hydroxide (Al(OH)3), were administered to healthy adults 50-85 years of age at antigen dose levels of 50, 100, or 200...” PMID 26993331 ↗ Mar 201634“Aluminum hydroxide suspension 2% is a pyrogen free, sterilized aluminum hydroxide wet gel suspension, placed into 2 mL Type 1 vials, containing an aluminum concentration of 10 mg/mL.” NCT05983874 ↗ “We assessed an Alhydrogel (aluminum hydroxide)-adjuvanted vaccine formulation at three ICC-1132 dose levels, each injected intramuscularly (1.0 mL) on study days 0, 56 and 168.” PMID 18253503 ↗ Feb 2008 “Investigational vaccine composed of Trimer 4571 100mcg, alum (aluminum hydroxide suspension) adjuvant 500mcg, and phosphate buffered saline diluent” NCT04985760 ↗ “Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent” NCT02382640 ↗ “Norovirus GI.1/GII.4 (15 μg/15 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection” NCT02153112 ↗ “Each 5 ml consists of Aluminum Hydroxide - 200 mg, Magnesium Hydroxide - 200 mg, and Simethicone - 20 mg.” NCT06321796 ↗ “Each 5 ml consists of Aluminum Hydroxide - 200 mg, Magnesium Hydroxide - 200 mg, and Simethicone - 20 mg.” NCT06503978 ↗ “30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide)” NCT01281501 ↗ “admixed with Aluminum Hydroxide Suspension (~625 mcg aluminum content)” NCT03284710 ↗ “200 mg aluminum hydroxide/200 magnesium hydroxide/25 mg simethicone” NCT05109390 ↗ “Aluminum hydroxide and magnesium hydroxide” NCT05028673 ↗ “Adjuvant - Aluminum hydroxide, 5 mg/mL” NCT03776994 ↗ “350µg of aluminum hydroxide adjuvant” NCT01995617 ↗ “Drug: Aluminum hydroxide” NCT00974935 ↗ |
| Known as | Al(OH)3 | “The toxoids, either alone or in combination with aluminum hydroxide (Al(OH)3), were administered to healthy adults 50-85 years of age at antigen dose levels of 50, 100, or 200...” PMID 26993331 ↗ Mar 20161“with or without aluminum hydroxide adjuvant [Al(OH)(3)]” PMID 19773098 ↗ Mar 2009 |
| Known as | Alhydrogel | “Aluminum hydroxide adjuvant (Alhydrogel®);given with SARS vaccine; 2 intramuscular doses, 28 days apart, Cohort 1: 12 subjects given vaccine with adjuvant at 5 micrograms per...” NCT01376765 ↗25“Safety and immunogenicity of a recombinant Plasmodium falciparum AMA1-DiCo malaria vaccine adjuvanted with GLA-SE or Alhydrogel® in European and African adults: A phase 1a/1b,...” PMID 28947345 ↗ Sep 2017 “intramuscular administration to Swiss volunteers of Alhydrogel and P27A antigen (50 microg)” NCT01949909 ↗ “A single low dose of quadrivalent VLP vaccine mixed with Alhydrogel®” NCT02236052 ↗ |
| Known as | AlOH | “We evaluated the dose-sparing potential of aluminum hydroxide (AlOH) adjuvant.” PMID 18808338 ↗ Nov 2008 |
| Known as | Alum | “Investigational vaccine composed of Trimer 4571 100mcg, alum (aluminum hydroxide suspension) adjuvant 500mcg, and phosphate buffered saline diluent” NCT04985760 ↗2“Aluminum hydroxide suspension (Alum) to be administered as 250 mcg (aluminum content) admixed with 426c.Mod.Core-C4b with 3M-052-AF.” NCT06613789 ↗ “aluminum hydroxide (alum)” NCT00001042 ↗ |
| Known as | aluminum hydroxide adjuvant (alum) | “Alhydrogel®, aluminum hydroxide adjuvant (alum)” NCT02067676 ↗ |
| Known as | aluminum hydroxide gel | “V180 adjuvanted with Alhydrogel™ (aluminum hydroxide gel, Brenntag Biosector, Frederikssund, Denmark) (N = 8), or placebo (N = 4)” PMID 32394880 ↗ May 2020 |
| Known as | aluminum hydroxide suspension | “Alhydrogel® (aluminum hydroxide suspension)” NCT00705835 ↗ |
| Known as | MSP3-CRM-Vac4All/ Alhydrogel | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05197751 ↗ |
| Known as | Pfs25-EPA/Alhydrogel | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01867463 ↗ |
| Known as | Pfs25H-EPA/Alhydrogel | “Safety and immunogenicity of Pfs25H-EPA/Alhydrogel, a transmission-blocking vaccine against Plasmodium falciparum” PMID 30061051 ↗ Jul 2018 |
| Modality | Other / unclassified | “The vaccine is mixed with Alhydrogel® (Registered Trademark), a material that is commonly added to vaccines to make them work better (also called an adjuvant).” NCT00427167 ↗ |
| Route | Intramuscular | “with or without aluminum hydroxide adjuvant by intramuscular (IM) injection” NCT00296634 ↗ |