Osmitrol

(Mannitol)

ApprovedSmall molecule

Mannitol is used to reduce swelling in the brain and eyes, and to help prevent kidney failure by increasing urine production. It works by drawing fluid out of tissues and into the bloodstream where it can be filtered out by the kidneys.[2] Osmitrol is currently approved and in use across 53 indications[4].[1]

Osmitrol is one of 1155 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

1,154

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseApproved

Ciguatera PoisoningApproved

DyspepsiaActive, not recruiting

PoisoningActive, not recruiting

Cerebral PalsyActive, not recruiting

Liver TransplantActive, not recruiting

ToxicityActive, not recruiting

Kidney CancerApproved

IschemiaActive, not recruiting

StrokeActive, not recruiting

Coronary Artery DiseaseApproved

Approved

Ciguatera PoisoningApproved

Approved

DyspepsiaApproved

Active, not recruiting

PoisoningPhase 3

Active, not recruiting

Cerebral PalsyPhase 2

Active, not recruiting

Liver TransplantPhase 1

Active, not recruiting

ToxicityPhase 2

Active, not recruiting

Kidney CancerApproved

Approved

IschemiaPhase 3

Active, not recruiting

StrokePhase 2

Active, not recruiting

Showing 10 of 50 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Osmitrol

BB. Braun Medical Inc.

Approved

2 2

Spikevax

Moderna

Preclinical

21 3

Aquasol E

NNational Eye Institute (NEI)

Preclinical

1 4

Tricor

JJagotec

Preclinical

1 5

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

1 6

Piperacillin/tazobactam

Pfizer

Preclinical

1 7

Biological Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

1 8

Blood Taken

HHospices Civils de Lyon

Preclinical

1 9

Pfizer-COVID-19 Vaccine

Moderna

Preclinical

1 10

Netakimab

SSPH-BIOCAD (HK) Limited

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Dyspepsia

NCT06841406

Q4 2027

Phase 2Recruiting

Stroke

NCT07080567

Q4 2028

Phase 3Recruiting

Congenital Heart Disease

NCT04217421

Q1 2029

Phase 2Not yet recruiting

Cerebral Palsy

NCT07433023

Clinical

Trials by Indication[1]

ESS4 trials

Change in Airway Responsiveness After Allergen Exposure

Completed·UUniversity of Saskatchewan·N/A·NCT01699594·11 enrolled

Hypertonic Saline vs. Mannitol for Elevated Intercranial Pressure

Terminated·UUniversity of Cincinnati·Phase 3·NCT01111682·5 enrolled

Mannitol (Aridol) and Methacholine (Provocholine) Responsiveness

Completed·UUniversity of Saskatchewan·Phase 4·NCT01642745·20 enrolled

Show 1 more trial

The Effect of Deep Inhalation on Mannitol Responsiveness

Completed·UUniversity of Saskatchewan·Phase 3·NCT03505489·26 enrolled

Cystic Fibrosis4 trials

Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis

Completed·SSyntara·Phase 2·NCT00117208·20 enrolled

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

Completed·SSyntara·Phase 3·NCT00446680·340 enrolled

Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients

Completed·SSyntara·Phase 1·NCT00792714·18 enrolled

Show 1 more trial

Mannitol Dose Response Study in Cystic Fibrosis

Completed·SSyntara·Phase 2·NCT00251056·48 enrolled

Brain Injury3 trials

The Effect of Mannitol Volume with Changes in Osmolarity in Traumatic Brain Injury

Completed·UUniversitas Diponegoro·Phase 3·NCT06846307·32 enrolled

Effect of Allopurinol for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome

Unknown status·UUniversity Hospital Tuebingen·Phase 3·NCT03162653·760 enrolled

Memantine as an Additive Therapy in Patients With Traumatic Brain Injury

Not yet recruiting·MMansoura University·Phase 2/3·NCT06914310·80 enrolled

Intracranial Pressure3 trials

Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF

Completed·IInstitute of Liver and Biliary Sciences, India·N/A·NCT02460510·52 enrolled

Adding Dexmedetomidine to Mannitol to Attenuate the Increase of Intracranial Pressure

Completed·—·Phase 2/3·NCT07064720·60 enrolled

Double Blind Study of Hypertonic Saline vs Mannitol in the Management of Increased Intracranial Pressure (ICP).

Withdrawn·—·N/A·NCT01108744

COVID-192 trials

Assessment of the Efficacy of Calcium Dobesilate vs. Placebo on SARS-CoV-2 Viral Load Amongst Outpatients With COVID-19.

Completed·HHervé SPECHBACH·Phase 2·NCT05305508·74 enrolled

#StayHome: Early Hydroxychloroquine to Reduce Secondary Hospitalisation and Household Transmission in COVID-19

Withdrawn·—·Phase 2/3·NCT04385264

58 more indications

Intracranial Hypertension2 trials

Coagulation Activation by Hyperosmolar Agents in Intracranial Hypertension

Withdrawn·NNeuromed IRCCS··NCT03409237

Osmotic Therapy for Treatment of Intracranial Hypertension for Traumatic Brain Injury

Withdrawn·IIndiana University·N/A·NCT01215019

Toxicity2 trials

The Effect of Intravenous Mannitol Plus Saline on the Prevention of Cisplatin-induced Nephrotoxicity: A Randomized, Double-blind, Placebo Controlled Trial

Completed·PPhramongkutklao College of Medicine and Hospital·Phase 2/3·NCT04251689·48 enrolled

Evaluation of the Effect of Acetazolamide, Mannitol and N-acetylcysteine on Cisplatin-Induced Nephrotoxicity

Completed·—·Phase 2·NCT02760901·52 enrolled

Craniotomy2 trials

Comparison of Two Doses of Mannitol on Brain Relaxation During Supratentorial Craniotomy

Completed·—·N/A·NCT01048684·80 enrolled

The Therapeutic Time Window of Mannitol During Craniotomy for Optimal Brain Relaxation in Patients With Supratentorial Tumours

Completed·HHuashan Hospital·N/A·NCT03444519·100 enrolled

Stroke2 trials

Manipulating the Peri-Infarct Area Using Maraviroc to Enhance Motor Skills After Stroke

Recruiting·EEmmanuel Carrera·Phase 2·NCT07080567·80 enrolled

Study of Stroke Related Edema Treatments

Withdrawn·UUniversity of Florida·Phase 2·NCT01954290

Orthognathic Surgery1 trial

Effect of Mannitol on Recovery Pattern After Orthognathic Surgery

Active, not recruiting·NNational Cancer Institute, Egypt·N/A·NCT06400355·60 enrolled

Malignant Brain Tumors1 trial

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

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT00238173·2 enrolled

ART1 trial

A Study of Two Formulations (Both Refrigerated and Room Temperature) Using an Autoinjector Device in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05154968·44 enrolled

Functional Outcomes1 trial

Assessment of Oncological and Functional Outcomes After Robot Assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy

Completed·LLuzerner Kantonsspital·N/A·NCT02924922·85 enrolled

Bronchiectasis1 trial

Safety and Efficacy of Bronchitol in Bronchiectasis

Completed·SSyntara·Phase 3·NCT00277537·354 enrolled

Germ Cell Tumor1 trial

Melphalan, Carboplatin, Mannitol, and Sodium Thiosulfate in Treating Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors

Unknown status·OOHSU Knight Cancer Institute·Phase 1/2·NCT00983398·17 enrolled

Acceptability1 trial

Study to Gather Information on the Acceptability of a New Flavor System With Increasing Levels of 2, 4, 6 g or Higher of Mannitol for PEG 3350 in Subjects Having Infrequent Bowel Movements.

Completed· Bayer logo

Bayer·Phase 4·NCT04534465·50 enrolled

Central Nervous System Lymphoma1 trial

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

Unknown status·OOHSU Knight Cancer Institute·Phase 1/2·NCT00293475·81 enrolled

Subarachnoid Hemorrhage1 trial

The Optimal Dose of Mannitol for Intraoperative Brain Relaxation During the Operation of Aneurysmal Subarachnoid Hemorrhage

Unknown status·—·Phase 1/2·NCT04135456·99 enrolled

Malaria1 trial

Mannitol as Adjunct Therapy for Childhood Cerebral Malaria

Unknown status·MMakerere University·Phase 3·NCT00113854·156 enrolled

Obstructive Sleep Apnea1 trial

Effect of AD128 to Treat Obstructive Sleep Apnea

Completed·RRaphael Heinzer·Phase 2/3·NCT04394143·15 enrolled

Glaucoma1 trial

Effect of Antiglaucoma Agents on Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection

Completed·MMashhad University of Medical Sciences·N/A·NCT02140450·70 enrolled

Oxygenation1 trial

Effect of Mannitol 20% Versus Hypertonic Saline 7.5% in Brain Metabolism and Oxygenation

Completed·—·Phase 4·NCT03573999·54 enrolled

Coagulation1 trial

Effects of Copaxone in the Retinal Function in Diabetic Patients After Panphotocoagulation

Unknown status·FFederal University of São Paulo·Phase 4·NCT00677664·30 enrolled

CHOP1 trial

Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN

Completed·UUniversity of Wisconsin, Madison·Phase 1·NCT00585260·66 enrolled

Prostatectomy1 trial

Effect of Mannitol on Optic Nerve Sheath Diameter in Patients Undergoing Robotic Prostatectomy

Completed·—··NCT03214055·39 enrolled

Atrial Fibrillation1 trial

A Study to Select the Dose and Evaluate the Effectiveness and Safety of the Drug Refralon®, Tablets, 1 mg for Long-term Use to Prevent Recurrence of Atrial Fibrillation/Flutter After Terminating Its Persistent Form

Recruiting·NNational Medical Research Center for Cardiology, Ministry of Health of Russian Federation·Phase 2·NCT06540352·200 enrolled

Glioblastoma Multiforme1 trial

Boron Phenylalanine With or Without Mannitol in Treating Patients With Glioblastoma Multiforme

Terminated·CCancer Research UK·Phase 1·NCT01233492·36 enrolled

Poisoning1 trial

Mannitol Versus Supportive Care in Ciguatera Fish Poisoning

Unknown status·UUniversity of South Florida·Phase 3·NCT02570971·200 enrolled

Exercise1 trial

U-LABA/ICS Effects on Exercise Performance, Formoterol

Completed·MMorten Hostrup, PhD·N/A·NCT06105671·20 enrolled

Opioid Dependence1 trial

Acute Effects of Cortisol on Heroin Craving in Opioid Dependence (Ghost-Basel)

Completed·PProf. Dominique de Quervain, MD·Phase 2·NCT01718964·30 enrolled

Head Injury1 trial

Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

Unknown status·AAbela Pharmaceuticals, Inc.·Phase 1/2·NCT00810940·30 enrolled

Bone Marrow Transplantation1 trial

Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

Completed·RRocky Mountain Cancer Centers·Phase 2·NCT00390624·20 enrolled

CAR1 trial

Evaluation of Ureteral Patency in the Post-indigo Carmine Era

Completed·—·Phase 4·NCT02677623·140 enrolled

Kidney Transplant1 trial

Mannitol Use During Cadaveric Kidney Transplantation

Unknown status·RRabin Medical Center·N/A·NCT04705402·32 enrolled

Asthma1 trial

Asthma Exacerbations and Vascular Function

Completed·UUniversity of Alberta·N/A·NCT02630511·52 enrolled

Acute1 trial

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

Withdrawn·SSyntara·Phase 1/2·NCT00446667

Congenital Heart Disease1 trial

Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass

Recruiting·Ddr. M.J.N.L. Benders·Phase 3·NCT04217421·236 enrolled

Colonoscopy1 trial

A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy

Completed· Ferring logo

Ferring·Phase 4·NCT02386449·184 enrolled

Bowel Preparation1 trial

Effectiveness of Mannitol Versus Polyethylene Glycol Electrolyte Dispersion as a Salve for Patients With Inadequate Bowel Preparation: a Randomized Controlled Clinical Trial

Unknown status·NNingbo No. 1 Hospital·N/A·NCT05912114·134 enrolled

Propofol1 trial

Effect of Mannitol on Propofol Level

Recruiting·—·Phase 4·NCT06884657·40 enrolled

Chronic Liver Failure1 trial

High Volume Plasma Exchange in Children With Acute Liver Failure and Acute on Chronic Liver Failure

Completed·IInstitute of Liver and Biliary Sciences, India·N/A·NCT02719210·75 enrolled

Ischemia1 trial

Mannitol Use During Partial Nephrectomy Prior to Renal Ischemia and Impact on Renal Function Outcomes

Completed·MMemorial Sloan Kettering Cancer Center·Phase 3·NCT01606787·210 enrolled

Intravenous Administration1 trial

Effect of Intravenous Administration of Mannitol on ONSD in Patients With Raised ICP

Completed·TTribhuvan University Teaching Hospital, Institute Of Medicine.··NCT04188353·40 enrolled

Treatment1 trial

Wheeze and Intermittent Treatment

Completed·QQueen Mary University of London·Phase 3·NCT01142505·1,358 enrolled

Hypotension1 trial

Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension

Completed·—·Phase 2·NCT01520207·52 enrolled

Neuralgia1 trial

Mannitol Cream for Post Herpetic Neuralgia

Completed·UUniversity of British Columbia·Phase 1/2·NCT02484170·20 enrolled

Indocyanine Green1 trial

A Dose-Image Optimization Trial Evaluating Mannitol and Voluven as Adjuncts for Indocyanine Green

Enrolling by invitation·NNational Taiwan University Hospital·Phase 1/2·NCT06768268·30 enrolled

Trial1 trial

Trial of Mannitol Cream for Pain Relief After a Long Run

Completed·UUniversity of British Columbia·Phase 1·NCT01843088·170 enrolled

Fetal Hypoxia1 trial

Antenatal Allopurinol During Fetal Hypoxia

Unknown status·UUMC Utrecht·Phase 3·NCT00189007·222 enrolled

Contrast Agent1 trial

Evaluation of the Performance of Two Neutral Oral Contrast Agents in CT Enterography

Unknown status·SShandong University·N/A·NCT03495804·60 enrolled

Brain Tumors1 trial

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

Completed·OOHSU Knight Cancer Institute·Phase 1/2·NCT00303849·33 enrolled

Peripheral Neuropathy1 trial

Topical Menthol +/- Mannitol for Painful Diabetic Peripheral Neuropathy

Completed·UUniversity of British Columbia·Phase 1/2·NCT02728687·72 enrolled

Cerebral Oxygen Saturation1 trial

Mannitol Improves Cerebral Oxygen Saturation

Completed·IImam Abdulrahman Bin Faisal University·Phase 4·NCT02091180·40 enrolled

Cerebral Palsy1 trial

tSCS and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy

Not yet recruiting·SShirley Ryan AbilityLab·Phase 2·NCT07433023·80 enrolled

Liver Transplant1 trial

Effect of Mannitol on Postreperfusion Syndrome During Living Donor Liver Transplant

Completed·—·Phase 1·NCT05277623·60 enrolled

Dyspepsia1 trial

Budesonide as a Treatment for Functional Dyspepsia

Recruiting·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT06841406·56 enrolled

Delayed Graft Function1 trial

Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation

Completed·MMedical University of Vienna·Phase 3·NCT02705573·34 enrolled

Completed·—·Phase 2/3·NCT04428372·31 enrolled

Hemodynamic1 trial

Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients

Terminated·TThe University of Texas Health Science Center at San Antonio··NCT00125229·10 enrolled

AIN1 trial

Brain Relaxation With Mannitol and Furosemide

Completed·IIstanbul University·N/A·NCT02712476·47 enrolled

Unspecified4 trials

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

Completed·SSyntara·Phase 1·NCT00446771·18 enrolled

The Leaky Lung Test

Completed·UUniversity of Rochester·Phase 1·NCT02306473·100 enrolled

Study of the Pathogenesis and Molecular Mechanism of "YURE" in Internal Intractable Diseases

Unknown status·NNanjing University of Traditional Chinese Medicine·Phase 2·NCT00569088·300 enrolled

Show 1 more trial

High Dose Inhaled Mannitol Study

Completed·SSyntara·Phase 1/2·NCT01076491·10 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

MANNITOL 25%

NDA NDA005620

Jan 1, 1982

OSMITROL 10% IN WATER

NDA NDA013684

Jan 1, 1982

RESECTISOL

NDA NDA016704

Jan 1, 1982

MANNITOL 10%

NDA NDA016080

Jan 1, 1982

RESECTISOL IN PLASTIC CONTAINER

NDA NDA016772

Jan 1, 1982

MANNITOL 10%

NDA NDA016269

Jan 1, 1982

MANNITOL 10%

NDA NDA016472

Jan 1, 1982

MANNITOL 20%

NDA NDA014738

Jan 8, 1987

MANNITOL 10% IN PLASTIC CONTAINER

NDA NDA019603

Jul 26, 1993

MANNITOL 10% IN PLASTIC CONTAINER

NDA NDA020006

Oct 5, 2010

ARIDOL KIT

NDA NDA022368

Oct 30, 2020

BRONCHITOL

NDA NDA202049

Sources

References

[1]
ClinicalTrials.gov — 81 trial records for Mannitol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Osmitrol drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Mannitol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Mannitol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA202049). U.S. Food & Drug Administration.
[6]
SEC EDGAR — B. Braun Medical Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: BB. Braun Medical Inc.

Osmitrol

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q4 2028

Q1 2029

Trials by Indication[1]

ESS4 trials

Cystic Fibrosis4 trials

Brain Injury3 trials

Intracranial Pressure3 trials

COVID-192 trials

Intracranial Hypertension2 trials

Toxicity2 trials

Craniotomy2 trials

Stroke2 trials

Orthognathic Surgery1 trial

Malignant Brain Tumors1 trial

ART1 trial

Functional Outcomes1 trial

Bronchiectasis1 trial

Germ Cell Tumor1 trial

Acceptability1 trial

Central Nervous System Lymphoma1 trial

Subarachnoid Hemorrhage1 trial

Malaria1 trial

Obstructive Sleep Apnea1 trial

Glaucoma1 trial

Oxygenation1 trial

Coagulation1 trial

CHOP1 trial

Prostatectomy1 trial

Atrial Fibrillation1 trial

Glioblastoma Multiforme1 trial

Poisoning1 trial

Exercise1 trial

Opioid Dependence1 trial

Head Injury1 trial

Bone Marrow Transplantation1 trial

CAR1 trial

Kidney Transplant1 trial

Asthma1 trial

Acute1 trial

Congenital Heart Disease1 trial

Colonoscopy1 trial

Bowel Preparation1 trial

Propofol1 trial

Chronic Liver Failure1 trial

Ischemia1 trial

Intravenous Administration1 trial

Treatment1 trial

Hypotension1 trial

Neuralgia1 trial

Indocyanine Green1 trial

Trial1 trial

Fetal Hypoxia1 trial

Contrast Agent1 trial

Brain Tumors1 trial

Peripheral Neuropathy1 trial

Cerebral Oxygen Saturation1 trial

Cerebral Palsy1 trial

Liver Transplant1 trial

Dyspepsia1 trial

Delayed Graft Function1 trial

Dialysis1 trial

Cardiac Surgery1 trial

Blood Pressure1 trial

Hemodynamic1 trial

AIN1 trial

Unspecified4 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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