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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/25 | Phase 2 | Not yet recruiting | |||
2025/04/06 | Phase 2 | Not yet recruiting | |||
2025/03/19 | Phase 4 | Not yet recruiting | |||
2025/02/26 | Phase 3 | Completed | |||
2025/02/24 | Phase 4 | Recruiting | |||
2025/01/10 | Phase 1 | ENROLLING_BY_INVITATION | |||
2024/08/06 | Phase 2 | Recruiting | National Medical Research Center for Cardiology, Ministry of Health of Russian Federation | ||
2024/05/06 | Not Applicable | Active, not recruiting | National Cancer Institute, Egypt | ||
2023/10/30 | Not Applicable | Completed | Morten Hostrup, PhD | ||
2023/08/07 | Phase 1 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| ICU Medical Inc. | 0990-7715 | INTRAVENOUS | 20 g in 100 mL | 5/7/2020 | |
| ICU Medical Inc. | 0990-7981 | URETHRAL | 0.54 g in 100 mL | 4/7/2021 | |
| Baxter Healthcare Corporation | 0338-0357 | INTRAVENOUS | 20 g in 100 mL | 11/15/2018 | |
| Chiesi USA, Inc. | 10122-212 | RESPIRATORY (INHALATION) | 40 mg in 1 1 | 1/12/2024 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1468 | INTRAVENOUS | 12.5 g in 50 mL | 1/27/2024 | |
| B. Braun Medical Inc. | 0264-7578 | INTRAVENOUS | 20 g in 100 mL | 8/15/2023 | |
| Henry Schein, Inc. | 0404-9905 | INTRAVENOUS | 12.5 g in 50 mL | 11/9/2023 | |
| Hospira, Inc. | 0409-4031 | INTRAVENOUS | 12.5 g in 50 mL | 3/30/2020 | |
| Fresenius Kabi USA, LLC | 63323-024 | INTRAVENOUS | 250 mg in 1 mL | 3/16/2023 | |
| Baxter Healthcare Corporation | 0338-0353 | INTRAVENOUS | 10 g in 100 mL | 11/15/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/13/2012 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| OSMOFUNDIN INJECTION 20% | SIN05957P | INJECTION | 17.5 g/100 ml | 5/27/1991 | |
| MANNITOL INTRAVENOUS INJECTION 20% | SIN10315P | INJECTION | 20 g/100 ml | 10/29/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Mannitol Irrigation Solution | 国药准字H20093928 | 化学药品 | 冲洗剂 | 3/30/2020 | |
| Mannitol Injection | 国药准字H53020143 | 化学药品 | 注射剂 | 8/28/2020 | |
| Mannitol Injection | 国药准字H53020146 | 化学药品 | 注射剂 | 8/28/2020 | |
| Mannitol Injection | 国药准字H32020417 | 化学药品 | 注射剂 | 9/9/2020 | |
| Mannitol Injection | 国药准字H44022709 | 化学药品 | 注射剂 | 9/18/2020 | |
| Mannitol Injection | 国药准字H36020155 | 化学药品 | 注射剂 | 7/17/2022 | |
| Mannitol Injection | 国药准字H23020608 | 化学药品 | 注射剂 | 10/24/2020 | |
| Mannitol Injection | 国药准字H61020003 | 化学药品 | 注射剂 | 8/18/2020 | |
| Mannitol Injection | 国药准字H32020062 | 化学药品 | 注射剂 | 8/24/2020 | |
| Mannitol Injection | 国药准字H51023949 | 化学药品 | 注射剂(注射液) | 7/21/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| BRONCHITOL mannitol 40 mg powder for inhalation hard capsule | 437010 | Medicine | A | 1/23/2024 | |
| OSMITROL Mannitol 100g/500mL injection AHB3025 | 19496 | Medicine | A | 9/30/1991 | |
| OSMITROL Mannitol 100g/L injection AHB3026 | 19479 | Medicine | A | 9/30/1991 | |
| BRONCHITOL mannitol 40mg powder for inhalation hard capsule | 168002 | Medicine | A | 3/11/2011 | |
| Aridol mannitol inhalation powder, hard capsules 0 mg, 5 mg, 10 mg, 20 mg, 40 mg | 445506 | Medicine | A | 4/8/2024 | |
| ARIDOL mannitol powder for inhalation composite pack | 116832 | Medicine | A | 4/11/2006 | |
| Bronchitol mannitol 40 mg inhalation powder, hard capsules | 444241 | Medicine | A | 3/22/2024 | |
| ARIDOL mannitol powder for inhalation, hard capsules 0 mg, 5 mg, 10 mg, 20 mg, 40 mg | 439258 | Medicine | A | 2/1/2024 | |
| BRONCHITOL (mannitol) inhalation powder, 40mg per capsule, for oral inhalation | 443970 | Medicine | A | 3/19/2024 | |
| BRONCHITOL mannitol 40mg powder for inhalation hard capsule | 187575 | Medicine | A | 8/10/2011 |
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