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Mannitol

Generic Name
Mannitol
Brand Names
Aridol, Bronchitol, Cystosol, Osmitrol, Sag-M
Drug Type
Small Molecule
Chemical Formula
C6H14O6
CAS Number
69-65-8
Unique Ingredient Identifier
3OWL53L36A
Background

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)
Associated Therapies
Bladder irrigation therapy

A Pharmacokinetic and Bioavailability Study of Mannitol for Inhalation Using Normal Subjects

Phase 1
Completed
Conditions
Healthy Volunteers
First Posted Date
2007-03-13
Last Posted Date
2007-03-13
Lead Sponsor
Syntara
Target Recruit Count
18
Registration Number
NCT00446771

Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study

Phase 3
Completed
Conditions
Cystic Fibrosis
Interventions
Drug: placebo
Drug: Mannitol
First Posted Date
2007-03-13
Last Posted Date
2010-06-25
Lead Sponsor
Syntara
Target Recruit Count
340
Registration Number
NCT00446680
Locations
🇮🇪

National Children's Hospital, Dublin, Ireland

🇮🇪

Our Lady's Hospital for Sick Children, Dublin, Ireland

🇦🇺

Royal Childrens Hospital, Melbourne, Victoria, Australia

and more 26 locations

A Pilot Safety Study of Inhaled Dry Powder Mannitol in Acute Exacerbations of COPD

Phase 1
Withdrawn
Conditions
COPD
Exacerbation
Interventions
First Posted Date
2007-03-13
Last Posted Date
2016-09-28
Lead Sponsor
Syntara
Registration Number
NCT00446667
Locations
🇦🇺

St George Hospital, Sydney, New South Wales, Australia

🇦🇺

Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

Phase 2
Completed
Conditions
Renal Dysfunction
Acute Renal Failure
Mortality
First Posted Date
2006-10-20
Last Posted Date
2008-06-03
Lead Sponsor
Rocky Mountain Cancer Centers
Target Recruit Count
20
Registration Number
NCT00390624
Locations
🇺🇸

Rocky Mountain Cancer Centers 1800 Williams Street, Suite 200, Denver, Colorado, United States

Carboplatin, Melphalan, Etoposide Phosphate, Mannitol, and Sodium Thiosulfate in Treating Patients With Previously Treated Brain Tumors

Phase 1
Completed
Conditions
Anaplastic Oligoastrocytoma
Anaplastic Oligodendroglioma
Mixed Glioma
Oligoastrocytoma
Interventions
Drug: Carboplatin
Drug: Etoposide
Drug: Etoposide Phosphate
Other: Laboratory Biomarker Analysis
Drug: Mannitol
Drug: Melphalan
Other: Quality-of-Life Assessment
Drug: Sodium Thiosulfate
First Posted Date
2006-03-17
Last Posted Date
2022-03-17
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
33
Registration Number
NCT00303849
Locations
🇺🇸

University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States

🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

Phase 1
Conditions
Central Nervous System Lymphoma
Interventions
Drug: Carboplatin
Drug: Mannitol
Drug: Methotrexate
Other: Quality-of-Life Assessment
Biological: Rituximab
Drug: Sodium Thiosulfate
First Posted Date
2006-02-17
Last Posted Date
2021-09-22
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
81
Registration Number
NCT00293475
Locations
🇺🇸

Cleveland Clinic Foundation, Cleveland, Ohio, United States

🇺🇸

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

🇺🇸

Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, United States

and more 1 locations

Safety and Efficacy of Bronchitol in Bronchiectasis

Phase 3
Completed
Conditions
Bronchiectasis
Interventions
Drug: placebo
Drug: Mannitol
First Posted Date
2006-01-16
Last Posted Date
2008-08-29
Lead Sponsor
Syntara
Target Recruit Count
354
Registration Number
NCT00277537
Locations
🇦🇺

Royal Perth Hospital, Perth, Western Australia, Australia

🇬🇧

Belfast City Hospital, Belfast, Northern Ireland, United Kingdom

🇦🇺

St George Hospital, Kogarah, New South Wales, Australia

and more 19 locations

Ability of Aridol to Detect Bronchial Hyperresponsiveness in Suspected Asthmatics

Phase 3
Completed
Conditions
Asthma
First Posted Date
2005-11-11
Last Posted Date
2009-12-01
Lead Sponsor
Syntara
Target Recruit Count
240
Registration Number
NCT00252291
Locations
🇺🇸

Colorado Asthma and Allergy Centers, 125 Rampart Way, Denver, Colorado, United States

Mannitol Dose Response Study in Cystic Fibrosis

Phase 2
Completed
Conditions
Cystic Fibrosis
Interventions
First Posted Date
2005-11-09
Last Posted Date
2008-08-29
Lead Sponsor
Syntara
Target Recruit Count
48
Registration Number
NCT00251056
Locations
🇨🇦

Hamilton Health Sciences Corporation, Hamilton, Ontario, Canada

🇦🇷

Hospital Pediatrico Dr Humberto J Notti, Mendoza, Argentina

🇦🇷

Hospital de Niños Superiora Sor María Ludovica, La Plata, Buenos Aires, Argentina

and more 9 locations

Acetylcysteine, Mannitol, Combination Chemotherapy, and Sodium Thiosulfate in Treating Children With Malignant Brain Tumors

Phase 1
Terminated
Conditions
Bone Marrow Suppression
Brain and Central Nervous System Tumors
Drug/Agent Toxicity by Tissue/Organ
Long-term Effects Secondary to Cancer Therapy in Children
First Posted Date
2005-10-13
Last Posted Date
2017-04-21
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
2
Registration Number
NCT00238173
Locations
🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

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