Overview
Mannitol is an osmotic diuretic that is metabolically inert in humans and occurs naturally, as a sugar or sugar alcohol, in fruits and vegetables. Mannitol elevates blood plasma osmolality, resulting in enhanced flow of water from tissues, including the brain and cerebrospinal fluid, into interstitial fluid and plasma. As a result, cerebral edema, elevated intracranial pressure, and cerebrospinal fluid volume and pressure may be reduced. Mannitol may also be used for the promotion of diuresis before irreversible renal failure becomes established; the promotion of urinary excretion of toxic substances; as an Antiglaucoma agent; and as a renal function diagnostic aid. On October 30, 2020, mannitol was approved by the FDA as add-on maintenance therapy for the control of pulmonary symptoms associated with cystic fibrosis in adult patients and is currently marketed for this indication under the name BRONCHITOL® by Chiesi USA Inc.
Indication
Used for the promotion of diuresis before irreversible renal failure becomes established, the reduction of intracranial pressure, the treatment of cerebral edema, and the promotion of urinary excretion of toxic substances. Mannitol is also indicated as add-on maintenance therapy for improving pulmonary function in cystic fibrosis patients aged 18 and over who have passed the BRONCHITOL tolerance test (BTT). It is recommended that patients take an orally inhaled short-acting bronchodilator 5-15 minutes prior to every inhaled mannitol dose.
Associated Conditions
- Acute Renal Failure (ARF)
- Cystic Fibrosis (CF)
- Edema of the cerebrum
- Increased Intra Ocular Pressure (IOP)
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/06/11 | Phase 2 | Recruiting | |||
2020/05/19 | Phase 2 | Completed | Raphael Heinzer | ||
2020/05/12 | Phase 2 | Withdrawn | Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland | ||
2020/02/05 | Phase 2 | Completed | Phramongkutklao College of Medicine and Hospital | ||
2020/01/03 | Phase 3 | Recruiting | dr. M.J.N.L. Benders | ||
2019/12/05 | N/A | Completed | Tribhuvan University Teaching Hospital, Institute Of Medicine. | ||
2019/10/22 | Phase 1 | Active, not recruiting | Beijing Tiantan Hospital | ||
2018/06/29 | Phase 4 | Completed | |||
2018/04/23 | Phase 3 | Completed | |||
2018/04/12 | Not Applicable | UNKNOWN | Shandong University |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Mannitol Injection | 国药准字H51020055 | 化学药品 | 注射剂(注射液) | 3/9/2021 | |
| Mannitol Injection | 国药准字H34020991 | 化学药品 | 注射剂 | 8/14/2020 | |
| Mannitol Injection | 国药准字H10983033 | 化学药品 | 注射剂 | 9/1/2020 | |
| Mannitol Injection | 国药准字H23020518 | 化学药品 | 注射剂 | 10/22/2020 | |
| Mannitol Injection | 国药准字H22022761 | 化学药品 | 注射剂 | 1/4/2024 | |
| Mannitol Injection | 国药准字H41022002 | 化学药品 | 注射剂 | 5/18/2020 | |
| Mannitol Injection | 国药准字H22021696 | 化学药品 | 注射剂 | 11/28/2023 | |
| Mannitol Injection | 国药准字H42020257 | 化学药品 | 注射剂 | 1/26/2024 | |
| Mannitol Injection | 国药准字H53021158 | 化学药品 | 注射剂 | 9/28/2020 | |
| Mannitol Injection | 国药准字H20056657 | 化学药品 | 注射剂 | 5/27/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
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