Drugs / Mannitol
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | MANNITOL 25% | — | 2020-03-17 | fda.gov ↗ |
| Label expansion | US (FDA) | MANNITOL 20% IN PLASTIC CONTAINER | — | 2019-09-24 | fda.gov ↗ |
| Label expansion | US (FDA) | OSMITROL 20% IN WATER IN PLASTIC CONTAINER | — | 2018-11-15 | fda.gov ↗ |
| Approved | EU (EMA) | Bronchitol | — | 2012-04-13 | europa.eu ↗ |
| Approved | US (FDA) | OSMITROL 20% IN WATER IN PLASTIC CONTAINER | — | 1964-06-08 | fda.gov ↗ |
Trials 65 · started per year
today
US approved 1964
EU approved 2012
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05761405 | Jan 2024 → Oct 2025 | urinary tract infection | Centre Hospitalier Universitaire Vaudois | Unknown | No outcome recorded |
| Phase 0 | NCT02306473 | Oct 2015 → Dec 2017 | allergic disease, asthma, obstructive lung disease, reactive airway disease | University of Rochester | Completed | No outcome recorded |
| Phase 18 trials | ||||||
| Phase 1 | NCT05154968 | Nov → Dec 2021 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01887197 | Jun 2013 → Dec 2017 | cystic fibrosis | Tim Corcoran | Completed | No outcome recorded |
| Phase 1 | NCT01843088 | May 2013 | — | University of British Columbia | Completed | No outcome recorded |
| Phase 1 | NCT01204866 | Jul → Aug 2010 | allergic disease | PharmAthene, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00792714 | Dec 2008 → Sep 2009 | cystic fibrosis | Syntara | Completed | No outcome recorded |
| Phase 1 | NCT01233492 | Oct 2007 → Sep 2013 | central nervous system neoplasm | Cancer Research UK | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT00446771 | Oct → Nov 2006 | — | Syntara | Completed | No outcome recorded |
| Phase 1 | NCT00359697 | — | intracranial hypertension | Thomas Jefferson University | Unknown | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT04135456 | Apr 2019 → Nov 2023 | acquired aneurysmal subarachnoid hemorrhage | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT02728687 | Mar 2017 → Mar 2020 | diabetic polyneuropathy | University of British Columbia | Completed | No outcome recorded |
| Phase 1/2 | NCT01076491 | Jan → Mar 2009 | bronchiectasis | Syntara | Completed | No outcome recorded |
| Phase 1/2 | NCT00730977 | Aug → Sep 2008 | bronchiectasis | Syntara | Completed | No outcome recorded |
| Phase 1/2 | NCT00446667 | Oct 2006 → Jun 2008 | chronic obstructive pulmonary disease | Syntara | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 25 trials | ||||||
| Phase 2 | NCT05129748 | Feb 2023 → Jan 2027 expected | platinum-induced ototoxicity | Sunnybrook Health Sciences Centre | Recruiting | No outcome recorded |
| Phase 2 | NCT00117208 | Nov 2005 → Feb 2008 | cystic fibrosis | Syntara | Completed | No outcome recorded |
| Phase 2 | NCT00117182 | Jul 2005 → Aug 2006 | chronic obstructive pulmonary disease | Syntara | Completed | No outcome recorded |
| Phase 2 | NCT00455130 | Mar 2004 → Aug 2005 | cystic fibrosis | Syntara | Completed | No outcome recorded |
| Phase 2 | NCT00390624 | Jul 2003 → Dec 2006 | acute kidney injury, impaired renal function disease | Rocky Mountain Cancer Centers | Completed | No outcome recorded |
| Phase 2/35 trials | ||||||
| Phase 2/3 | NCT07064720 | Jul 2024 → Dec 2025 | — | Cairo University | Completed | No outcome recorded |
| Phase 2/3 | NCT04842331 | Sep 2021 → Jan 2022 | COVID-19, viral respiratory tract infection | Thirty Respiratory Limited | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT04428372 | Apr 2021 → Dec 2024 | — | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 2/3 | NCT04251689 | Dec 2018 → Jul 2020 | cisplatin toxicity | Phramongkutklao College of Medicine and Hospital | Completed | No outcome recorded |
| Phase 2/3 | NCT00319345 | Nov 2003 → Nov 2005 | intracranial hypertension, traumatic brain injury | Institut d'Anesthesiologie des Alpes Maritimes | Terminated | No outcome recorded |
| Phase 314 trials · 2 met primary · 5 missed | ||||||
| Phase 3 | NCT07465705 | Sep 2025 → Mar 2026 overdue | — | NTC srl | Recruiting | No outcome recorded |
| Phase 3 | NCT04870073 | Sep 2022 | coronary artery disorder | Hamilton Health Sciences Corporation | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT04386070 | May 2022 → Dec 2026 | COVID-19, severe acute respiratory syndrome | University of Birmingham | Suspended | No outcome recorded |
| Phase 3 | NCT03505489 | Jun 2018 → Apr 2019 | asthma | University of Saskatchewan | Completed | Missed primary |
| Phase 3 | NCT02705573 | Jan → Jun 2018 | — | Medical University of Vienna | Completed | No outcome recorded |
| Phase 3 | NCT02570971 | Oct 2015 → Jun 2018 | ciguatera fish poisoning | University of South Florida | Unknown | No outcome recorded |
| Phase 3 | NCT02134353 | Sep 2014 → Feb 2017 | cystic fibrosis | Syntara | Completed | Met primary |
| Phase 3 | NCT01606787 | May 2012 → Feb 2018 | kidney cancer | Memorial Sloan Kettering Cancer Center | Completed | Missed primary |
| Phase 3 | NCT00669331 | Nov 2009 → Jan 2014 | bronchiectasis | Syntara | Completed | Missed primary |
| Phase 3 | NCT00630812 | Sep 2008 → Apr 2010 | cystic fibrosis | Syntara | Completed | Missed primary |
| Phase 3 | NCT00446680 | Mar 2007 → May 2010 | cystic fibrosis | Syntara | Completed | Met primary |
| Phase 3 | NCT00277537 | Mar 2006 → Jul 2008 | bronchiectasis | Syntara | Completed | Mixed |
| Phase 3 | NCT00252291 | Nov 2005 → Sep 2006 | asthma | Syntara | Completed | No outcome recorded |
| Phase 3 | NCT00113854 | Oct 2004 → May 2005 | cerebral malaria | Makerere University | Unknown | Missed primary |
| Phase 410 trials · 1 met primary | ||||||
| Phase 4 | NCT05740618 | Mar 2023 → Jan 2025 | cystic fibrosis | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 4 | NCT03105843 | Mar 2022 → Jun 2026 overdue | cough variant asthma | Dr. Diane Lougheed | Recruiting | No outcome recorded |
| Phase 4 | NCT02677623 | Mar 2015 → Aug 2016 | — | Columbia University | Completed | No outcome recorded |
| Phase 4 | NCT02037815 | Jan → Apr 2014 | brain edema | Capital Medical University | Completed | Met primary |
| Phase 4 | NCT04534465 | Feb → Mar 2013 | constipation disorder | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT02091180 | Jan → Nov 2013 | — | Imam Abdulrahman Bin Faisal University | Completed | No outcome recorded |
| Phase 4 | NCT01745081 | Sep 2012 → Sep 2014 | intracranial hypertension | University of Sherbrooke | Unknown | No outcome recorded |
| Phase 4 | NCT01642745 | Nov 2011 → Feb 2013 | asthma | University of Saskatchewan | Completed | No outcome recorded |
| Phase 4 | NCT00426192 | Oct 2003 → Nov 2004 | — | University Hospital, Saarland | Unknown | No outcome recorded |
| Phase 4 | NCT00447018 | Oct 2002 → Jun 2005 | intracranial hypertension | University Hospital, Grenoble | Completed | No outcome recorded |
| Phase not applicable16 trials · 1 met primary · 1 missed | ||||||
| — | NCT07817706 | Sep 2026 → Jun 2027 expected | — | Mayo Clinic | Recruiting | No outcome recorded |
| — | NCT07605260 | Sep 2024 → Feb 2025 | cataract | Muhammad Aamir Latif | Completed | No outcome recorded |
| — | NCT06304181 | Mar → Aug 2024 | — | The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Unknown | No outcome recorded |
| — | NCT06105671 | Jan → Jul 2024 | — | Morten Hostrup, PhD | Completed | No outcome recorded |
| — | NCT05912114 | Jun 2023 → Dec 2024 | — | Ningbo No. 1 Hospital | Unknown | Met primary |
| — | NCT04705402 | Feb 2022 | — | Rabin Medical Center | Unknown | No outcome recorded |
| — | NCT03808649 | Jan → Mar 2019 | chronic thromboembolic pulmonary hypertension | Shandong University | Unknown | No outcome recorded |
| — | NCT03444519 | Mar 2018 → Mar 2019 | supratentorial cancer | Huashan Hospital | Completed | No outcome recorded |
| — | NCT03818126 | Jul 2016 → Jun 2018 | aortic valve disorder, ischemic disease | Pawel Buszman | Completed | No outcome recorded |
| — | NCT02630511 | Dec 2015 → Dec 2020 | asthma | University of Alberta | Completed | No outcome recorded |
| — | NCT02168075 | Jun 2014 → May 2016 | supratentorial cancer | Seoul National University Hospital | Unknown | No outcome recorded |
| — | NCT02460510 | Jun 2014 → Nov 2015 | acute liver failure | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| — | NCT01699594 | Oct 2012 → May 2014 | allergic asthma | University of Saskatchewan | Completed | No outcome recorded |
| — | NCT01048684 | Apr 2010 → May 2011 | brain neoplasm, intracranial hypertension | University of Montreal Hospital Centre (CHUM) | Completed | No outcome recorded |
| — | NCT00199511 | Jan 2005 → Apr 2007 | primary brain neoplasm | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | No outcome recorded |
| — | NCT00175227 | May 1996 → Oct 2000 | acute kidney injury, chronic kidney disease | University of Alberta | Completed | Missed primary |
| Comparator or background therapy50 trials | ||||||
| Phase 0 | NCT05277623 Comparator | Apr → Nov 2022 | liver disorder | Ain Shams University | Completed | No outcome recorded |
| Phase 1 | NCT01180816 Background | Aug 2010 → Dec 2017 | anaplastic astrocytoma, glioblastoma | Northwell Health | Completed | No outcome recorded |
| Phase 1 | NCT01238237 Background | Dec 2009 → Jan 2016 | anaplastic astrocytoma, glioblastoma | Northwell Health | Completed | No outcome recorded |
| Phase 1 | NCT00238173 Background | Dec 2004 → Feb 2006 | bone marrow disorder, central nervous system cancer, chemotherapy-induced toxicity | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT06768268 Comparator | Jan → Dec 2025 overdue | female breast carcinoma | National Taiwan University Hospital | Enrolling by invitation | No outcome recorded |
| Phase 1/2 | NCT02861898 Background | Jun 2016 → Dec 2028 expected | brain cancer, glioblastoma | Northwell Health | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02484170 Comparator | Sep 2015 → Apr 2016 | postherpetic neuralgia | University of British Columbia | Completed | No outcome recorded |
| Phase 1/2 | NCT01605357 Comparator | Jul 2012 → Jul 2013 | brain edema, traumatic brain injury | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT00810940 Comparator | Oct 2010 → Dec 2011 | brain injury | Abela Pharmaceuticals, Inc. | Unknown | No outcome recorded |
| Phase 1/2 | NCT00983398 Background | Jul 2009 → Dec 2021 | childhood supratentorial embryonal tumor with multilayered rosettes, C19MC-altered, malignant germ cell tumor, medulloblastoma, medulloepithelioma | OHSU Knight Cancer Institute | Unknown | No outcome recorded |
| Phase 1/2 | NCT00293475 Background | Oct 2005 → Jan 2022 | primary central nervous system lymphoma | OHSU Knight Cancer Institute | Unknown | No outcome recorded |
| Phase 1/2 | NCT00303849 Background | Sep 2005 → Mar 2021 | anaplastic oligoastrocytoma, anaplastic oligodendroglioma | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT02819479 Background | Nov 2016 → Jun 2019 | radiation-induced disorder | Norton Healthcare | Completed | Mixed |
| Phase 2 | NCT02800486 Background | May 2016 → May 2035 expected | anaplastic astrocytoma, anaplastic oligoastrocytoma, brain cancer, glioblastoma | Northwell Health | Recruiting | No outcome recorded |
| Phase 2 | NCT01954290 Comparator | Sep 2015 | brain edema, stroke disorder | University of Florida | Withdrawn | No outcome recorded |
| Phase 2 | NCT02760901 Comparator | Nov 2013 → Oct 2015 | cisplatin toxicity | Ain Shams University | Completed | No outcome recorded |
| Phase 2 | NCT01883531 Comparator | Jun 2013 → Oct 2015 | cystic fibrosis | Syntara | Completed | No outcome recorded |
| Phase 2 | NCT01520207 Comparator | May 2012 → Jul 2016 | — | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00569088 Comparator | Nov 2007 → Apr 2010 | stroke disorder | Nanjing University of Traditional Chinese Medicine | Unknown | No outcome recorded |
| Phase 2 | NCT00251056 Comparator | Oct 2005 → Aug 2008 | cystic fibrosis | Syntara | Completed | No outcome recorded |
| Phase 2/3 | NCT06914310 Background | Mar → Aug 2025 overdue | traumatic brain injury | Mansoura University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT03749408 Comparator | Dec 2012 → Jun 2014 | pulpitis | Cairo University | Completed | No outcome recorded |
| Phase 3 | NCT06473779 Background | Sep 2024 → Jun 2027 expected | asthma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06846307 Comparator | Nov 2023 → Jan 2024 | traumatic brain injury | Universitas Diponegoro | Completed | No outcome recorded |
| Phase 3 | NCT05707442 Comparator | Feb 2023 → Jan 2027 expected | spontaneous intracranial hypotension | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT04488874 Comparator | Sep 2020 → May 2023 | intracranial hypertension | Centre Hospitalier Universitaire de Besancon | Completed | Missed primary |
| Phase 3 | NCT01111682 Comparator | Apr → Nov 2010 | intracranial hypertension, traumatic brain injury | University of Cincinnati | Terminated | No outcome recorded |
| Phase 3 | NCT01028339 Comparator | Jul 2008 → Jun 2012 | traumatic brain injury | Central Directorate of the Army Health Service | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00313872 Background | May 2003 → Jun 2009 | gastric cancer, metastatic neoplasm | Samsung Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT06884657 Comparator | Mar → Oct 2025 overdue | — | Cukurova University | Recruiting | No outcome recorded |
| Phase 4 | NCT04243655 Background | Dec 2019 → Oct 2020 | liver disorder | Asian Institute of Gastroenterology, India | Unknown | No outcome recorded |
| Phase 4 | NCT03573999 Comparator | Jun 2018 → Oct 2019 | brain edema, disorder of acid-base balance | Aristotle University Of Thessaloniki | Completed | No outcome recorded |
| Phase 4 | NCT02386449 Comparator | Feb → Dec 2015 | — | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT02760862 Comparator | Oct 2014 → Nov 2015 | headache disorder | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT00795587 Comparator | Oct 2008 → Aug 2011 | intracranial hypertension, traumatic brain injury | University Hospital, Grenoble | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT07726134 Comparator | Sep 2026 → Aug 2028 expected | — | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Recruiting | No outcome recorded |
| — | NCT06400355 Comparator | Mar → Jun 2024 overdue | — | National Cancer Institute, Egypt | Active not recruiting | No outcome recorded |
| — | NCT05647057 Background | Jul 2023 → Jul 2024 | — | Amsterdam UMC, location VUmc | Completed | No outcome recorded |
| — | NCT04314674 Comparator | Apr 2020 → Apr 2022 | adult glioblastoma, metastatic malignant neoplasm in the brain | Istanbul University | Unknown | No outcome recorded |
| — | NCT05914896 Comparator | Apr 2019 → Jun 2020 | acute kidney injury | Umeå University | Completed | No outcome recorded |
| — | NCT03495804 Comparator | Nov 2017 → Sep 2018 | chronic thromboembolic pulmonary hypertension | Shandong University | Unknown | No outcome recorded |
| — | NCT02924922 Comparator | May 2016 → Dec 2018 | kidney neoplasm | Luzerner Kantonsspital | Completed | No outcome recorded |
| — | NCT02719210 Comparator | Jan 2016 → Nov 2018 | acute liver failure | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| — | NCT01963910 Comparator | Dec 2013 → Jan 2014 | — | University of British Columbia | Completed | No outcome recorded |
| — | NCT02712476 Comparator | Jul 2013 → May 2015 | brain neoplasm | Istanbul University | Completed | No outcome recorded |
| — | NCT02140450 Comparator | Feb 2012 → Jan 2014 | — | Mashhad University of Medical Sciences | Completed | No outcome recorded |
| — | NCT01108744 Comparator | Jan 2012 → Jan 2014 | intracranial hypertension | Beth Israel Deaconess Medical Center | Withdrawn | No outcome recorded |
| — | NCT01215019 Comparator | Oct 2010 → Oct 2020 | traumatic brain injury | Indiana University | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT01554930 Comparator | May → Nov 2010 | hand, foot and mouth disease | Jiangxi Qingfeng Pharmaceutical Co. Ltd. | Completed | No outcome recorded |
| — | NCT00042367 Background | Apr 2000 → Dec 2005 | brain cancer | Baylor College of Medicine | Completed | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 115 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mannitol | “The medical treatment consisted of acetazolamide (0.5-4 g/day) and short-term mannitol (bolus of 0.25-1 g/kg body weight) for a duration of about 1 week or repeated lumbar...” NCT05707442 ↗114“A single dose of Intraarterial Mannitol to open the blood brain barrier followed by Intra-arterial Temozolomide single dose (starting at 75mg/m2 and up to 250mg/m2)” NCT01180816 ↗ “The del Nido components are: Plasma-Lyte A (1000ml), Mannitol 20% (16.3ml), MgSO4 50% (4ml) , NaHCO3 8.4% (13ml) , KCl 2mEq/mL (13ml), Lidocaine 1% (13ml).” NCT03818126 ↗ “prime solution containing Ringer-Acetate 1000 ml + Mannitol 400 ml (60 g) + Sodium-Chloride 40 ml (160 mmol) and Heparin 2 ml (10 000 IU)” NCT05914896 ↗ “RESP301 is a formulation consisting of three agents already used in clinical practice: mannitol, sodium nitrite and citric acid.” NCT04386070 ↗ “RESP301 is a formulation consisting of 3 agents currently used in clinical practice: mannitol, sodium nitrite and citric acid.” NCT04842331 ↗ “Intraarterial Mannitol 25% 3-10 ml to open the blood brain barrier followed by Intraarterial Cetuximab single dose” NCT01238237 ↗ “Mannitol (30 mg/mL) will be diluted in saline to the following concentrations: 1:1000, 1:100, 1:10, and 1:1” NCT01204866 ↗ “administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure” NCT04243655 ↗ “Cisplatin 3.5 mg/kg + mannitol 0.4 g/kg in D5 NS (1000 ml/m2) over 6 hrs” NCT00042367 ↗ “20% Mannitol 70 mL IV full dripping, 30 mins before cisplatin” NCT00313872 ↗ |
| Known as | Aridol | “The purpose of this study is to determine whether the Aridol (mannitol) challenge test can predict response to treatment with inhaled corticosteroids in COPD subjects.” NCT00117182 ↗ |
| Known as | Bronchitol | “Treatment With Bronchitol (Dry Powder Mannitol) in the Symptomatic Treatment of Bronchiectasis.” NCT00277537 ↗ |
| Known as | IDPM | “A Pilot Study to Investigate the Tolerability of Inhaled Dry Powder Mannitol (IDPM) Administered Via a Novel Dry Powder Inhaler Device in Healthy Individuals and Subjects With...” NCT00730977 ↗ |
| Known as | Osmitrol | “Mannitol (Israeli Brand Name: Osmitrol) is in the osmotic diuretic pharmacologic categoryaccording to the American Hospital Formulary Service (AHFS) database.” NCT04705402 ↗ |
| Action | Inhibit | “mannitol down-regulates or blocks the TRPV1 (transient receptor potential vanilloid 1) receptor” NCT01963910 ↗ |
| Modality | Diagnostic / imaging agent | “Aridol (mannitol) challenge test” NCT00117182 ↗ |
| Route | Intravenous | “intravenous mannitol given to children with cerebral malaria” NCT00113854 ↗ |
| Target | TRPV1 | “mannitol down-regulates or blocks the TRPV1 (transient receptor potential vanilloid 1) receptor” NCT01963910 ↗ |