Mannitol 20%, Bronchitol(mannitol)
Aridol, Bronchitol, 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, Osmitrol (generic drugs available since 1982-01-01, discontinued: Resectisol)
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
Mannitol
+
Sorbitol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SORBITOL-MANNITOL IN PLASTIC CONTAINER | ICU Medical | N-018316 RX | 1982-01-01 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| aridol bronchial challenge test kit | New Drug Application | 2020-09-02 |
| bronchitol | New Drug Application | 2020-11-10 |
| osmitrol | New Drug Application | 2018-11-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| anuria | EFO_0009530 | D001002 | R34 |
| brain edema | EFO_1000845 | D001929 | G93.6 |
| ocular hypertension | EFO_1001069 | D009798 | H40.0 |
| oliguria | — | D009846 | — |
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
146 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 | — | 2 | 2 | 8 | 14 |
| Intracranial hypertension | D019586 | EFO_1000992 | 1 | 1 | 3 | 2 | 4 | 10 | |
| Traumatic brain injuries | D000070642 | S06 | 1 | 2 | 3 | 1 | 2 | 7 | |
| Brain edema | D001929 | EFO_1000845 | G93.6 | 1 | 2 | — | 2 | 1 | 5 |
| Anesthesia | D000758 | — | — | — | 1 | 1 | 2 | ||
| Intracranial pressure | D007427 | — | — | — | 1 | 1 | 2 | ||
| Headache | D006261 | HP_0002315 | R51 | — | — | — | 1 | — | 1 |
| Constipation | D003248 | HP_0002019 | K59.0 | — | — | — | 1 | — | 1 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | — | — | 1 | — | 1 | |
| Inflammation | D007249 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 2 | 5 | 3 | — | — | 10 |
| Bronchiectasis | D001987 | HP_0002110 | J47 | 2 | 2 | 2 | — | — | 4 |
| Covid-19 | D000086382 | U07.1 | — | 2 | 1 | — | — | 2 | |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | — | — | 1 | — | 1 | 2 |
| Drug-related side effects and adverse reactions | D064420 | T88.7 | — | 1 | 1 | — | 1 | 2 | |
| Pulpitis | D011671 | EFO_1001139 | K04.0 | — | 1 | 1 | — | — | 1 |
| Respiratory sounds | D012135 | HP_0010307 | R06.1 | — | — | 1 | — | — | 1 |
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | — | — | 1 | — | — | 1 |
| Neuroprotection | D000066829 | — | — | 1 | — | — | 1 | ||
| Newborn infant diseases | D007232 | — | — | 1 | — | — | 1 |
Show 14 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | 2 | — | — | 4 | 6 |
| Healthy volunteers/patients | — | 5 | 1 | — | — | — | 5 | ||
| Glioblastoma | D005909 | EFO_0000515 | 1 | 2 | — | — | 1 | 3 | |
| Obstructive lung diseases | D008173 | HP_0006536 | 1 | 1 | — | — | — | 2 | |
| Glioma | D005910 | EFO_0000520 | 1 | 2 | — | — | — | 2 | |
| Astrocytoma | D001254 | EFO_0000271 | 1 | 2 | — | — | — | 2 | |
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | 1 | — | — | — | 2 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 2 | — | — | — | 2 |
| Craniocerebral trauma | D006259 | S00 | 2 | 2 | — | — | — | 2 | |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 2 | 2 | — | — | — | 2 |
Show 15 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | 1 | — | — | — | 1 | 2 |
| Central nervous system neoplasms | D016543 | 2 | — | — | — | — | 2 | ||
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
| Burns | D002056 | T30.0 | 1 | — | — | — | — | 1 | |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute liver failure | D017114 | — | — | — | — | 3 | 3 | ||
| Cough | D003371 | HP_0012735 | R05 | — | — | — | — | 3 | 3 |
| Supratentorial neoplasms | D015173 | C71.0 | — | — | — | — | 3 | 3 | |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | — | 2 | 2 |
| Wheelchairs | D014910 | — | — | — | — | 1 | 1 | ||
| Dietary supplements | D019587 | — | — | — | — | 1 | 1 | ||
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Body weight | D001835 | EFO_0004338 | — | — | — | — | 1 | 1 | |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | — | — | 1 | 1 |
| Nutrition disorders | D009748 | EFO_0001069 | — | — | — | — | 1 | 1 |
Show 18 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 |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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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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31,601 adverse events reported
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