Clinical Trials

Numerous clinical trials spanning Phase I through Phase IV evaluate D-Mannitol across diverse indications, including bronchiectasis, cystic fibrosis, ototoxic hearing loss, postdural puncture headache, adult glioblastoma, and renal dysfunction. Sponsored by industry entities such as Syntara and DNage B.V. alongside academic medical centers like Sahlgrenska University Hospital and Sunnybrook Health Sciences Centre, these studies encompass completed, actively recruiting, terminated, and withdrawn statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06990984 NOT_YET_RECRUITING
Leigh Syndrome
Thiogenesis Therapeutics, Inc.
 2026-10 PHASE2
NCT07235995 NOT_YET_RECRUITING
Postoperative Delirium; Elderly; Non Cardiac Surgery
Xiangya Hospital of Central South University
 2025-12-01 PHASE4
NCT05129748 RECRUITING
Ototoxic Hearing Loss
Sunnybrook Health Sciences Centre
 2023-02-15 PHASE2
NCT03105843 COMPLETED
Asthma; Cough; Cough Variant Asthma
Dr. Diane Lougheed
 2022-03-01 PHASE4
NCT07495449 COMPLETED
Acute Ocular Hypertension Glaucoma; Intraocular Hypertension; Primary Angle-Closure Glaucoma
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
 2025-01-09
NCT05555290 COMPLETED
Asthma
AstraZeneca
 2022-09-28 PHASE3
NCT06304181 UNKNOWN
Postoperative Analgesia
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
 2024-03-15
NCT05034367 COMPLETED
Cough
Kuopio University Hospital
 2022-01-17
NCT04314674 UNKNOWN
Brain Tumor - Metastatic; Brain Tumor, Adult: Glioblastoma
Istanbul University
 2020-04
NCT03823638 UNKNOWN
Parkinson Disease
Hadassah Medical Organization
 2018-11-20 PHASE2
NCT03089723 UNKNOWN
Rhizarthrosis; Metabolic Disease
University of Sao Paulo General Hospital
 2017-03-30
NCT03242434 TERMINATED
Burns
GlaxoSmithKline
 2018-01-29 PHASE1
NCT02767154 COMPLETED
Heart Disease
Sahlgrenska University Hospital
 2016-05 PHASE2
NCT02134353 COMPLETED
Cystic Fibrosis
Syntara
 2014-09 PHASE3
NCT02760862 COMPLETED
Headache
Ain Shams University
 2014-10 PHASE4
NCT01883531 COMPLETED
Cystic Fibrosis
Syntara
 2013-06 PHASE2
NCT00669331 COMPLETED
Bronchiectasis
Syntara
 2009-11 PHASE3
NCT02104284 COMPLETED
Asthma
BL&H Co., Ltd
 2011-07
NCT01605357 WITHDRAWN
Traumatic Brain Injury; Subdural Hematoma; Cerebral Contusion; Head Injury; Cerebral Edema
Massachusetts General Hospital
 2012-07 PHASE1; PHASE2
NCT01142154 COMPLETED
Cockayne Syndrome
DNage B.V.
 2010-06 PHASE1; PHASE2
NCT01142154 Completed
Cockayne Syndrome
DNage B.V.
 2010-06 Phase 1|Phase 2
NCT00630812 COMPLETED
Cystic Fibrosis
Syntara
 2008-09 PHASE3
NCT00792714 COMPLETED
Cystic Fibrosis
Syntara
 2008-12 PHASE1
NCT00730977 COMPLETED
Healthy; Bronchiectasis
Syntara
 2008-08 PHASE1; PHASE2
NCT00117208 COMPLETED
Cystic Fibrosis
Syntara
 2005-11 PHASE2
NCT00390624 COMPLETED
Renal Dysfunction; Acute Renal Failure; Mortality
Rocky Mountain Cancer Centers
 2003-07 PHASE2
NCT00455130 COMPLETED
Cystic Fibrosis
Syntara
 2004-03 PHASE2
NCT00426192 UNKNOWN
Inflammation
University Hospital, Saarland
 2003-10 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-07-24)

Check the D-Mannitol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

D-Mannitol acts as an osmotic agent and weak renal vasodilator that increases the osmolality of plasma and renal tubular fluid, thereby driving water reabsorption inhibition and osmotically drawing intracellular fluid into the extracellular space. This hyperosmolar shift reduces tissue edema and promotes airway mucociliary clearance, mediating therapeutic benefit in clinical conditions such as cystic fibrosis, bronchiectasis, and acutely elevated intracranial pressure.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.