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Drug

Mannitol

Approved · EMA
Emerging researchLate-stage development
Also known as Bronchitol, D-(-)-Mannitol, D-Mannitol, Manna Sugar+10 more

Bronchitol, D-(-)-Mannitol, D-Mannitol, Manna Sugar, Mannitol, Injectable, Mannitol-Sorbitol, Osmitrol, Resectisol, Manitol, Mannit, Mannite, (2R,3R,4R,5R)-hexane-1,2,3,4,5,6-hexaol, (2R,3R,4R,5R)-hexane-1,2,3,4,5,6-hexol, Mannitolum.

RxNorm6628ChEMBLCHEMBL689ATCB05CX04ATCB05BC01ATCA06AD16ATCR05CB16ATCV04CX04UNII3OWL53L36A
2
Research papers
10
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Budesonide as a Treatment for Low-grade Duodenal Inflammation in Functional Dyspepsia

Clinical trial2026-05-31Primary completion · ClinicalTrials.gov

Advancing Neurorehabilitation: Evaluating Transcutaneous Spinal Stimulation and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy

Clinical trial2026-05-29Results expected Q1 2029 · ClinicalTrials.gov

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Select the Dose and Evaluate the Effectiveness and Safety of the Drug Refralon®, Tablets, 1 mg (Pharmproekt JSC) for Long-term Use to Prevent Recurrence of Atrial Fibrillation/Flutter After Terminating Its Persistent Form

Clinical trial2026-04-08Results expected Q4 2026 · ClinicalTrials.gov

Effect of ALlopurinol in Addition to Hypothermia for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome - a Blinded Randomized Placebo-controlled Parallel Group Multicenter Trial for Superiority (Phase III)

Clinical trial2026-01-31Primary completion · ClinicalTrials.gov

Adding Dexmedetomidine to Mannitol to Attenuate the Increase of Intracranial Pressure

Clinical trial2026-01-15Completed · ClinicalTrials.gov

Advanced Research on ICG Fluorescence Imaging-Guided Surgery Technique Using Mannitol and Voluven as Adjuncts

Clinical trial2025-12-31Primary completion · ClinicalTrials.gov

A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough

Clinical trial2025-12-16Results posted · ClinicalTrials.gov

Propofol Level at TCI During Mannitol

Clinical trial2025-10-20Primary completion · ClinicalTrials.gov

Memantine as an Additive Therapy in Patients With Traumatic Brain Injury

Clinical trial2025-08-30Primary completion · ClinicalTrials.gov

Investigation of the metabolic and endocrinological differences between daily and weekly growth hormone replacement therapy, somapacitan, in patients with adult growth hormone deficiency: A real-world pilot study.

Research2023-09-01Medicine

Approval: Bronchitol (EMA)

Regulatory2012-04-13EMA

Arabidopsis AtMYC2 (bHLH) and AtMYB2 (MYB) function as transcriptional activators in abscisic acid signaling.

Research2003-01-01The Plant cell

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Mannitol
Aliases & brands
BronchitolD-(-)-MannitolD-MannitolManna SugarMannitol, InjectableMannitol-SorbitolOsmitrolResectisolManitolMannitMannite(2R,3R,4R,5R)-hexane-1,2,3,4,5,6-hexaol(2R,3R,4R,5R)-hexane-1,2,3,4,5,6-hexolMannitolum
RxNorm CUI
6628
ChEMBL ID
CHEMBL689
ATC codes
B05CX04B05BC01A06AD16R05CB16V04CX04
UNII
3OWL53L36A
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2012-04-13
Latest approval
2012-04-13
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2012-04-13Approval
Approval: Bronchitol (EMA)

Indication: Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

82 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
82
registered trials across all phases
LATEST COMPLETION 2026
10
Active studies
8
Recruiting
48
Late-stage (III+)
47
Completed
25
Discontinued
PHASE DISTRIBUTIONn = 82
Early Phase 13Phase 17Phase 1 / 29Phase 215Phase 2 / 36Phase 315Phase 49Phase N / A18

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Budesonide as a Treatment for Low-grade Duodenal Inflammation in Functional Dyspepsia

RecruitingPH IVUniversitaire Ziekenhuizen KU Leuvenn=562026

Propofol Level at TCI During Mannitol

RecruitingPH IVCukurova Universityn=402025

Effect of Isosmotic Doses of Mannitol 20% Versus Hypertonic Saline 7.5% in Brain Metabolism and Oxygenation in Supratentorial Craniotomies

CompletedPH IVAristotle University Of Thessalonikin=542019

Evaluation of Ureteral Patency in the Post-indigo Carmine Era

CompletedPH IVColumbia Universityn=1402016

A Randomized, Controlled, Parallel Group, Assessor-Blinded Study To Compare The Efficacy, Tolerability, And Safety Of Oral Sodium Picosulfate (PicoPrep®) Versus Oral Mannitol and Bisacodyl, For Colon Cleansing In Colonoscopy Preparation Of Adult Outpatients

CompletedPH IVFerring Pharmaceuticalsn=1842015

Recent completions

Trials that read out recently, adding to the completed evidence base.

Adding Dexmedetomidine to Mannitol to Attenuate the Increase of Intracranial Pressure

CompletedPH II/IIICairo Universityn=602026

Effect of Intravenous Mannitol on Anterior Chamber Depth and Intraocular Pressure in Patients Before Cataract Surgery.

CompletedN/AMuhammad Aamir Latifn=602025

MAnnitol for Blood Pressure Stability in HemoDialysis (MAP-HD)

CompletedPH II/IIIBrigham and Women's Hospitaln=312024

A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamic Effects Of GDC-6599 In Patients With Chronic Cough

CompletedPH IIGenentech, Inc.n=492024

Physiological Responses to U-LABA/ICS With Emphasis on Exercise Performance in Well-Trained Individuals, Formoterol

CompletedN/AMorten Hostrup, PhDn=202024

A Randomized, Placebo-controlled, Double-blind, Monocenter, Phase II Trial to Assess the Efficacy of Calcium Dobesilate (CaD) vs. Placebo on SARS-CoV-2 Viral Load Amongst Outpatients With COVID-19.

CompletedPH IIHervé SPECHBACHn=742024

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20032023
Major research themes2
Endocrinology1Human Growth Hormone1
Journals, researchers & institutions
Top journals
  • Medicine1
  • The Plant cell1
Leading researchers
  • Abe H1
  • Abe I1
  • Abe M1
  • Fujita Y1
  • Ito T1
  • Kobayashi K1
  • Koga M1
  • Kudo T1
Leading institutions
free-text, unnormalised
  • Clinical Research Support Center1
  • Fukuoka University1
  • Fukuoka University Chikushi Hospital1
  • Japan International Research Center for Agricultural Sciences1
  • Nagasaki Prefecture Iki Hospital1

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Histidine

Frequently co-studied with Mannitol in the research literature.

1 shared paper
Phenol

Frequently co-studied with Mannitol in the research literature.

1 shared paper
Somapacitan

Frequently co-studied with Mannitol in the research literature.

1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.