ARIDOL KIT (mannitol) · PHARMAXIS EUROPE
Mannitol injection is an osmotic diuretic indicated for the reduction of intracranial pressure, the treatment of cerebral edema, and the reduction of elevated intraocular pressure. (Note: This applies to injectable formulations like Osmitrol, not the Aridol inhalation kit).
How ARIDOL KIT Works
Mannitol increases the osmolarity of the extracellular fluid, inducing the movement of water from the intracellular space into the vascular system. In the kidneys, mannitol elevates the osmolarity of the glomerular filtrate, hindering the tubular reabsorption of water and enhancing the excretion of sodium and chloride. This osmotic effect results in reduced intracranial and intraocular pressure.
Details
- Status
- Prescription
- First Approved
- 2010-10-05
- Routes
- INHALATION
- Dosage Forms
- POWDER
ARIDOL KIT Approval History
What ARIDOL KIT Treats
3 indicationsARIDOL KIT is approved for 3 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
ARIDOL KIT Boxed Warning
RISK OF SEVERE BRONCHOSPASM Mannitol, the active ingredient in ARIDOL, acts as a bronchoconstrictor and may cause severe bronchospasm. Bronchial challenge testing with ARIDOL is for diagnostic purposes only. Bronchial challenge testing with ARIDOL should only be conducted by trained professionals under the supervision of a physician familiar with all aspects of the bronchial challenge test and the management of acute bronchospasm. Medications (such as short-acting inhaled beta-agonist) and equip...
WARNING: RISK OF SEVERE BRONCHOSPASM Mannitol, the active ingredient in ARIDOL, acts as a bronchoconstrictor and may cause severe bronchospasm. Bronchial challenge testing with ARIDOL is for diagnostic purposes only. Bronchial challenge testing with ARIDOL should only be conducted by trained professionals under the supervision of a physician familiar with all aspects of the bronchial challenge test and the management of acute bronchospasm. Medications (such as short-acting inhaled beta-agonist) and equipment to treat severe bronchospasm must be present in the testing area. If severe bronchospasm occurs it should be treated immediately by administration of a short-acting inhaled beta-agonist. Because of the potential for severe bronchoconstriction, the bronchial challenge testing with ARIDOL should not be performed in any patient with clinically apparent asthma or very low baseline pulmonary function tests (e.g., FEV 1 <1-1.5 liters or <70% of the predicted values) [ see Warnings and Precautions ( 5.1 ) ]. WARNING: RISK OF SEVERE BRONCHOSPASM See full prescribing information for complete boxed warning. Mannitol, the active ingredient in ARIDOL, acts as a bronchoconstrictor and may cause severe bronchospasm. Bronchial challenge testing with ARIDOL is for diagnostic purposes only. Only trained professionals under the supervision of a physician who are familiar with the management of acute bronchospasm should perform bronchial challenge testing with ARIDOL. Medications (such as short-acting inhaled beta-agonist) and equipment to treat severe bronchospasm must be present in the testing area. Because of the potential for severe bronchoconstriction, bronchial challenge testing with ARIDOL should not be performed in any patient with clinically apparent asthma or very low baseline pulmonary function tests (e.g., FEV 1 <1-1.5 liters or <70% of the predicted values) ( 5.1 )
ARIDOL KIT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ARIDOL KIT
3 of 15FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
32 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07433023 | STU00225218 | Ph 2 | recruiting | tSCS and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy |
| NCT06540352 | REF-II-08-2023 | Ph 2 | active not recruiting | 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 |
| NCT04428372 | 2019P003681 | Ph 2, Ph 3 | completed | MAnnitol for Blood Pressure Stability in HemoDialysis (MAP-HD) |
| NCT06884657 level | mannitol Anesthesia | Ph 4 | recruiting | Effect of Mannitol on Propofol Level |
| NCT07080567 MASTER | 2024-02359 215285 | Ph 2 | recruiting | Manipulating the Peri-Infarct Area Using Maraviroc to Enhance Motor Skills After Stroke |
| NCT06914310 | 2024-88 | Ph 2, Ph 3 | not yet recruiting | Memantine as an Additive Therapy in Patients With Traumatic Brain Injury |
| NCT06846307 | 1554/EC/KEPK-RSDK/2023 | Ph 3 | completed | The Effect of Mannitol Volume With Changes in Osmolarity in Traumatic Brain Injury |
| NCT06841406 BuDy | S64291 | Ph 4 | recruiting | Budesonide as a Treatment for Functional Dyspepsia |
| NCT04385264 #StayHome | Unisante | Ph 2, Ph 3 | withdrawn | #StayHome: Early Hydroxychloroquine to Reduce Secondary Hospitalisation and Household Transmission in COVID-19 |
| NCT04217421 CRUCIAL | METC UMCU 18-791 2017-004596-31 | Ph 3 | recruiting | Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass |
| NCT05305508 COVID-19 | 2022-00000 | Ph 2 | completed | Assessment of the Efficacy of Calcium Dobesilate vs. Placebo on SARS-CoV-2 Viral Load Amongst Outpatients With COVID-19. |
| NCT04870073 RAPPER-MAN | RAPPER-MAN_2021 | Ph 3 | withdrawn | Retrograde Autologous Priming and Mannitol for Reducing Hemodilution in Cardiac Surgery |
| NCT04251689 MACIN | R023h/62 | Ph 2, Ph 3 | completed | The Effect of Intravenous Mannitol Plus Saline on the Prevention of Cisplatin-induced Nephrotoxicity: A Randomized, Double-blind, Placebo Controlled Trial |
| NCT05154968 | 18167 J3G-MC-S003 | Ph 1 | completed | A Study of Two Formulations (Both Refrigerated and Room Temperature) Using an Autoinjector Device in Healthy Participants |
| NCT04394143 | 2020-00315 | Ph 2, Ph 3 | completed | Effect of AD128 to Treat Obstructive Sleep Apnea |
| NCT03573999 | OsmoMetOx | Ph 4 | completed | Effect of Mannitol 20% Versus Hypertonic Saline 7.5% in Brain Metabolism and Oxygenation |
| NCT02728687 | M for PDPN | Ph 1, Ph 2 | completed | Topical Menthol +/- Mannitol for Painful Diabetic Peripheral Neuropathy |
| NCT04534465 results posted | 18160 | Ph 4 | completed | 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. |
| NCT02677623 results posted | AAAP3450 | Ph 4 | completed | Evaluation of Ureteral Patency in the Post-indigo Carmine Era |
| NCT03505489 | MAN-2018 | Ph 3 | completed | The Effect of Deep Inhalation on Mannitol Responsiveness |
| NCT02705573 | 2021/2014 | Ph 3 | completed | Effects of Mannitol on Delayed Graft Function After Cadaveric Renal Transplantation |
| NCT01606787 results posted | 12-079 | Ph 3 | completed | Mannitol Use During Partial Nephrectomy Prior to Renal Ischemia and Impact on Renal Function Outcomes |
| NCT02760901 | master | Ph 2 | completed | Evaluation of the Effect of Acetazolamide, Mannitol and N-acetylcysteine on Cisplatin-Induced Nephrotoxicity |
| NCT01954290 | 136-2013 | Ph 2 | withdrawn | Study of Stroke Related Edema Treatments |
| NCT02386449 CLEAR PREP | 000180 | Ph 4 | completed | A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy |
| NCT01142505 WAIT | 08/43/03 2009-015626-11 | Ph 3 | completed | Wheeze and Intermittent Treatment |
| NCT02091180 | 2012069 | Ph 4 | completed | Mannitol Improves Cerebral Oxygen Saturation |
| NCT01718964 Ghost-Basel | 2012DR2144 | Ph 2 | completed | Acute Effects of Cortisol on Heroin Craving in Opioid Dependence (Ghost-Basel) |
| NCT01111682 | Shutter-2010-01 | Ph 3 | terminated | Hypertonic Saline vs. Mannitol for Elevated Intercranial Pressure |
| NCT01028339 | SSH versus mannitol | Ph 3 | terminated | Mannitol vs HS to Treat ICHT After Severe TBI : Comparison on PtiO2 and Microdialysis Values |
| NCT01076491 | DPM-DEV-102b DPM-DEV-102b | Ph 1, Ph 2 | completed | High Dose Inhaled Mannitol Study |
| NCT00792714 DPM-PK-102 | DPM-PK-102 | Ph 1 | completed | Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ARIDOL KIT FDA Label Details
Indications & Usage
FDA Label (PDF)ARIDOL is indicated for the assessment of bronchial hyperresponsiveness in adult and pediatric patients 6 years of age or older who do not have clinically apparent asthma. Limitations of Use: ARIDOL is not a standalone test or a screening test for asthma. Bronchial challenge testing with ARIDOL should be used only as part of a physician's overall assessment of asthma. ARIDOL is a sugar alcohol indicated for the assessment of bronchial hyperresponsiveness in adult and pediatric patients 6 years of age or older who do not have clinically apparent asthma. Limitations of Use: ARIDOL is not a stand...
WARNING: RISK OF SEVERE BRONCHOSPASM Mannitol, the active ingredient in ARIDOL, acts as a bronchoconstrictor and may cause severe bronchospasm. Bronchial challenge testing with ARIDOL is for diagnostic purposes only. Bronchial challenge testing with ARIDOL should only be conducted by trained profess...
Track ARIDOL KIT with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.