Mannitol 25%, Bronchitol(mannitol)
Aridol, Bronchitol, Mannitol, Osmitrol (mannitol) is a small molecule pharmaceutical. Mannitol was first approved as Mannitol 20% on 1982-01-01. It is used to treat anuria, brain edema, ocular hypertension, and oliguria in the USA. It has been approved in Europe to treat cystic fibrosis.
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Commercial
Trade Name
FDA
EMA
Aridol, Bronchitol, Mannitol, Osmitrol (discontinued: Mannitol, Resectisol)
CombinationsSorbitol-mannitol (discontinued: Sorbitol-mannitol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mannitol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MANNITOL 5% IN PLASTIC CONTAINER | B. Braun Medical | N-020006 RX | 1993-07-26 | 1 products |
| MANNITOL 10% IN PLASTIC CONTAINER | B. Braun Medical | N-020006 RX | 1993-07-26 | 1 products |
| MANNITOL 15% IN PLASTIC CONTAINER | B. Braun Medical | N-020006 RX | 1993-07-26 | 1 products |
| MANNITOL 20% IN PLASTIC CONTAINER | B. Braun Medical | N-020006 RX | 1993-07-26 | 1 products |
| OSMITROL 5% IN WATER | Baxter | N-013684 RX | 1982-01-01 | 1 products |
| OSMITROL 10% IN WATER | Baxter | N-013684 RX | 1982-01-01 | 1 products |
| OSMITROL 20% IN WATER | Baxter | N-013684 RX | 1982-01-01 | 1 products |
| OSMITROL 15% IN WATER | Baxter | N-013684 RX | 1982-01-01 | 1 products |
| OSMITROL 5% IN WATER IN PLASTIC CONTAINER | Baxter | N-013684 RX | 1982-01-01 | 1 products |
| OSMITROL 10% IN WATER IN PLASTIC CONTAINER | Baxter | N-013684 RX | 1982-01-01 | 1 products |
Show 6 marketed
Show 22 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| aridol bronchial challenge test kit | New Drug Application | 2025-02-13 |
| bronchitol | New Drug Application | 2024-09-03 |
| curestem cell healer c10 program | unapproved drug other | 2020-06-08 |
| curestem cell healer c20 | unapproved drug other | 2020-06-05 |
| curestem cell healer c5 program | unapproved drug other | 2020-06-05 |
| gd11 rx scm c5 | unapproved drug other | 2017-08-24 |
| imuflex wb-rp blood bag system with integral whole blood leukocyte reduction filter (saving platelets) with diversion blood sampling arm anticoagul... | New Drug Application | 2024-10-21 |
| imuflex wb-sp blood bag system with integral whole blood leukocyte reduction filter (saving platelets) with diversion blood sampling arm anticoagul... | New Drug Application | 2024-12-17 |
| leuprolide acetate depot | New Drug Application | 2024-08-27 |
| lutrate depot | New Drug Application | 2025-06-03 |
Show 7 more
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
MANNITOL, BRONCHITOL, CHIESI | |||
| 2027-10-30 | ODE-327 | ||
| 2023-10-30 | NP | ||
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A06: Drugs for constipation
— A06A: Drugs for constipation
— A06AD: Osmotically acting laxatives
— A06AD16: Mannitol
B: Blood and blood forming organ drugs
— B05: Blood substitutes and perfusion solutions
— B05B: Iv solutions used in parenteral administration of fluids, electrolytes and nutrients
— B05BC: Solutions producing osmotic diuresis
— B05BC01: Mannitol
— B05C: Irrigating solutions, blood substitutes and perfusion
— B05CX: Other irrigating solutions in atc
— B05CX04: Mannitol
R: Respiratory system drugs
— R05: Cough and cold preparations
— R05C: Expectorants, excl. combinations with cough suppressants
— R05CB: Mucolytics
— R05CB16: Mannitol
V: Various drug classes in atc
— V04: Diagnostic agents
— V04C: Other diagnostic agents in atc
— V04CX: Other diagnostic agents in atc
— V04CX04: Mannitol
Clinical
Clinical Trials
500 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | 2 | 4 | 4 | 7 | 13 | 30 |
| Intracranial hypertension | D019586 | EFO_1000992 | — | 1 | 1 | 4 | 2 | 9 | 16 |
| Brain injuries | D001930 | — | S06.9 | 1 | 3 | 6 | 2 | 6 | 15 |
| Traumatic brain injuries | D000070642 | — | S06 | 1 | 3 | 5 | 2 | 5 | 13 |
| Infections | D007239 | EFO_0000544 | — | 2 | 5 | 5 | 1 | 1 | 12 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 3 | 5 | 3 | 1 | — | 12 |
| Syndrome | D013577 | — | — | 2 | 4 | 1 | 1 | 4 | 11 |
| Brain edema | D001929 | EFO_1000845 | G93.6 | 2 | 2 | — | 2 | 6 | 11 |
| Communicable diseases | D003141 | — | — | 1 | 4 | 5 | 1 | — | 10 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 4 | 1 | 1 | 1 | 3 | 9 |
Show 58 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibrosis | D005355 | — | — | 3 | 5 | 3 | — | 1 | 12 |
| Glioblastoma | D005909 | EFO_0000515 | — | 7 | 5 | 1 | — | 2 | 11 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | 3 | 5 | — | 2 | 11 |
| Covid-19 | D000086382 | — | U07.1 | — | 4 | 8 | — | — | 10 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | 2 | 5 | — | 1 | 9 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 4 | 1 | — | 2 | 8 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 2 | 5 | 2 | — | — | 8 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 3 | 4 | — | — | 7 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 5 | 1 | — | 1 | 7 |
| Ischemia | D007511 | EFO_0000556 | — | 1 | 2 | 4 | — | 1 | 7 |
Show 98 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 35 | 3 | — | — | 4 | 41 |
| Neoplasms | D009369 | — | C80 | 9 | 10 | — | — | 3 | 15 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 4 | 3 | — | — | 6 | 11 |
| Astrocytoma | D001254 | EFO_0000271 | — | 6 | 4 | — | — | — | 7 |
| Acute kidney injury | D058186 | — | N17 | — | 2 | — | — | 5 | 7 |
| Obstructive lung diseases | D008173 | — | — | 2 | 2 | — | — | 2 | 6 |
| Central nervous system neoplasms | D016543 | — | — | 6 | 4 | — | — | — | 6 |
| Renal insufficiency | D051437 | — | N19 | — | 1 | — | — | 5 | 6 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | 1 | 1 | — | — | 3 | 5 |
| Carcinoma | D002277 | — | C80.0 | 2 | 2 | — | — | — | 4 |
Show 123 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 2 | — | — | — | 2 | 4 |
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 1 | — | — | — | 1 | 2 |
| Lung neoplasms | D008175 | — | C34.90 | 2 | — | — | — | — | 2 |
| Cerebral hemorrhage | D002543 | — | — | 1 | — | — | — | 1 | 2 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 2 | — | — | — | — | 2 |
| Phenylketonurias | D010661 | — | E70.0 | 2 | — | — | — | — | 2 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | — | — | — | — | 1 |
| Preleukemia | D011289 | — | — | 1 | — | — | — | — | 1 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | — | — | — | — | 1 |
Show 28 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | — | — | — | 8 | 8 |
| Cardiac surgical procedures | D006348 | — | — | — | — | — | — | 4 | 4 |
| Supratentorial neoplasms | D015173 | — | C71.0 | — | — | — | — | 4 | 4 |
| Diabetes insipidus | D003919 | — | E23.2 | — | — | — | — | 3 | 3 |
| Acute liver failure | D017114 | — | — | — | — | — | — | 3 | 3 |
| Middle cerebral artery infarction | D020244 | EFO_1001045 | G46.0 | — | — | — | — | 3 | 3 |
| Infarction | D007238 | EFO_0009463 | — | — | — | — | — | 3 | 3 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | — | — | — | 2 | 2 |
| Memory | D008568 | — | — | — | — | — | — | 2 | 2 |
| Intestinal diseases | D007410 | — | K63.9 | — | — | — | — | 2 | 2 |
Show 78 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Mannitol |
| INN | — |
| Description | D-mannitol is the D-enantiomer of mannitol. It has a role as an osmotic diuretic, a sweetening agent, an antiglaucoma drug, a metabolite, an allergen, a hapten, a food bulking agent, a food anticaking agent, a food humectant, a food stabiliser, a food thickening agent, an Escherichia coli metabolite and a member of compatible osmolytes. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO |
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Estimated US medical usage
Mannitol
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Safety
Black-box Warning
Black-box warning for: Aridol bronchial challenge test kit
Adverse Events
Top Adverse Reactions
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3,698 adverse events reported
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