MedPath

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

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)

Research Report

Published: Aug 3, 2025

An Expert Monograph on Mannitol: Chemistry, Pharmacology, and Clinical Applications

1. Drug Identification and Overview

1.1. Introduction to Mannitol

Mannitol is a small molecule drug, classified chemically as a six-carbon sugar alcohol, or polyol.[1] It is a versatile and critically important agent in modern medicine, primarily functioning as a potent osmotic diuretic.[3] Chemically, it is a hexahydric alcohol related to the sugar mannose and is a stereoisomer of sorbitol.[2] Its multifaceted utility spans a wide range of clinical scenarios. Therapeutically, it holds a vital role in emergency and critical care settings for the reduction of acutely elevated intracranial pressure (ICP) associated with cerebral edema and for lowering high intraocular pressure (IOP) in conditions like glaucoma.[1] It is also employed to promote diuresis in certain renal conditions, to facilitate the elimination of toxins, and as a diagnostic agent to measure kidney function.[1] In a distinct application, an inhaled formulation of Mannitol serves as an adjunctive therapy for managing the pulmonary symptoms of cystic fibrosis.[1]

Beyond its direct therapeutic roles, Mannitol is extensively utilized in the pharmaceutical and food industries. Its unique physicochemical properties, including chemical stability, non-hygroscopicity, and safety profile, make it a valuable pharmaceutical excipient in various dosage forms.[6] In the food sector, it functions as a low-calorie sweetener and texturizing agent.[4] The compound is identified by the DrugBank Accession Number DB00742 and the Chemical Abstracts Service (CAS) Registry Number 69-65-8.[1]

1.2. Chemical and Physical Profile

A thorough understanding of Mannitol's clinical and industrial applications begins with its fundamental chemical and physical characteristics.

Chemical Identity

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/23
Not Applicable
Recruiting
Emmanuel Carrera
2025/07/15
Not Applicable
Recruiting
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

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
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
MANNITOL INJECTION, USP
fresenius kabi canada ltd
02243176
Solution - Intravenous
25 %
4/9/2002
OSMITROL INJECTION 20%
baxter corporation
00060437
Solution - Intravenous
20 %
12/31/1989
SAG-M
02386925
Solution - 0-Unassigned
0.525 % / W/V
1/20/2013
MANNITOL INJ 5% ABBOVAC
ABBOTT LABORATORIES, LIMITED
00037982
Liquid - Intravenous
50 MG / ML
12/31/1963
MANNITOL INJ 25%
International Medication Systems Ltd.
00243809
Liquid - Intravenous
250 MG / ML
12/31/1971
MANNITOL INJ 25%
astra pharma inc.
00729183
Liquid - Intravenous
250 MG / ML
12/31/1987
MANNITOL INJ 10% ABBOVAC
ABBOTT LABORATORIES, LIMITED
00037990
Liquid - Intravenous
100 MG / ML
12/31/1963
ARIDOL
02489562
Powder ,  Kit - Inhalation
10 MG / CAP
6/15/2020
ARIDOL
02489562
Powder ,  Kit - Inhalation
40 MG / CAP
6/15/2020
ARIDOL
02489562
Powder ,  Kit - Inhalation
20 MG / CAP
6/15/2020

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
CELSIOR SOLUCION PARA LA CONSERVACION DE ORGANOS
Institut Georges Lopez
73767
SOLUCIÓN PARA CONSERVACIÓN DE ÓRGANOS
Uso Hospitalario
Commercialized
OSMOFUNDINA 10% SOLUCIÓN PARA PERFUSION
B Braun Medical S.A.
43559
SOLUCIÓN PARA PERFUSIÓN
Medicamento Sujeto A Prescripción Médica
Commercialized
CORHUM SOLUCIÓN PARA CARDIOPLEJIA
S.A.L.F. S.P.A. Laboratorio Farmacologico
89242
SOLUCION PARA CARDIOPLEJIA
Uso Hospitalario
Not Commercialized
CUSTODIOL SOLUCION PARA CARDIOPLEJIA Y PARA CONSERVACION DE ORGANOS
Dr. Franz Koehler Chemie Gmbh
84838
SOLUCION PARA CARDIOPLEJIA/CONSERVACION DE ORGANOS
Uso Hospitalario
Commercialized
MANITOL MEIN 10% solución para perfusión
Fresenius Kabi España, S.A.U.
42568
SOLUCIÓN PARA PERFUSIÓN
Medicamento Sujeto A Prescripción Médica
Commercialized
OSMOHALE POLVO PARA INHALACION (CAPSULAS DURAS)
69945
POLVO PARA INHALACIÓN (CÁPSULA DURA)
Uso Hospitalario
Commercialized
BRONCHITOL 40 MG POLVO PARA INHALACION, CAPSULAS DURAS
112760
POLVO PARA INHALACIÓN (CÁPSULA DURA)
Uso Hospitalario
Commercialized
HIDROFUNDIN GLUCOSADO SOLUCION PARA PERFUSION
B Braun Medical S.A.
69694
SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
HIDROFUNDIN FISIOLOGICO SOLUCION PARA PERFUSION
B Braun Medical S.A.
69695
SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
MANITOL MEIN 20% solución para perfusión
Fresenius Kabi España, S.A.U.
42569
SOLUCIÓN PARA PERFUSIÓN
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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