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mannitol

Trade name: Osmitrol

Small moleculeapproved

Approved

Jun 8, 1964

Mannitol is a type of sugar alcohol used as a sweetener and medication. It is used as a low calorie sweetener as it is poorly absorbed by the intestines. As a medication, it is used to decrease pressure in the eyes, as in glaucoma, and to lower increased intracranial pressure. Medically, it is given by injection or inhalation. Effects typically begin within 15 minutes and last up to 8 hours. — Wikipedia

Clinical trial activity

142 trials · 184 clinical orgs · 16 marketing orgs

Phase 1
32
Phase 2
58
Phase 3
33
Phase 4
17

Earliest trial started May 1, 1996 (NCT00175227)

Timeline

1960s

  1. Jun 8, 1964

    Earliest FDA Approval

  2. Jun 8, 1964

    Baxalta — NDA Secondary Org

  3. Jun 8, 1964

    Baxter — NDA Secondary Org

  4. Jul 30, 1964

    B. Braun — NDA Secondary Org

  5. Dec 22, 1967

    Hospira — NDA Secondary Org

1970s

  1. Aug 20, 1971

    Hospira — Marketing Organization

  2. Aug 11, 1972

    Fresenius — Marketing Organization

  3. Aug 29, 1975

    International Medication — Marketing Organization

1980s

  1. Feb 22, 1980

    ICU Medical Inc — NDA Secondary Org

  2. Jun 10, 1980

    Abraxis — Marketing Organization

  3. Jan 21, 1982

    Lutipold — Marketing Organization

  4. May 6, 1987

    Teligent Pharmaceuticals — Marketing Organization

2000s

  1. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Oct 5, 2010

    Syntara — NDA Secondary Org

2020s

  1. Oct 30, 2020

    Chiesi — Marketing Organization

  2. Oct 30, 2020

    Chiesi — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedJun 8, 1964

Chemistry & pharmacology

Loading structure…

SMILES

OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO
Mol. weight
182.17 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral, Topical
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

Yes

Sources

Also known as

  • (2r,3r,4r,5r)-hexane-1,2,3,4,5,6-hexaol
  • (2r,3r,4r,5r)-hexane-1,2,3,4,5,6-hexaol
  • (2r,3r,4r,5r)-hexane-1,2,3,4,5,6-hexol
  • (2r,3r,4r,5r)-hexane-1,2,3,4,5,6-hexol
  • aridol kit
  • bronchitol
  • bronchitol
  • bronchitol
  • diosmol
  • diosmol
  • d-mannitol
  • d-mannitol
  • d-mannitol
  • d-mannitol
  • d-mannitol
  • d-mannitol
  • d-(-)-mannitol
  • d-(-)-mannitol
  • e421
  • e421
  • e421
  • e 421
  • e 421
  • fraxinine
  • fraxinine
  • manitol
  • manitol
  • manna sugar
  • manna sugar
  • manna sugar
  • mannit
  • mannit
  • mannite
  • mannite
  • mannite
  • mannitol
  • mannitol
  • mannitol
  • mannitol
  • mannitol
  • mannitol
  • mannitol
  • mannitol
  • mannitol
  • mannitol
  • mannitol,d-
  • mannitolum
  • mannitolum
  • osmitrol
  • osmitrol
  • resectisol
  • resectisol

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06990984Phase 2Oct 31, 2025Thiogenesis Therapeutics, Inc., University of Pennsylvania
NCT07110519Early Phase 1 (Phase 1)Sep 17, 2025St. Jude Children's Hospital
NCT07080567Phase 2Jul 14, 2025University of Geneva
NCT06914310Phase 2/Phase 3 (Phase 3)Mar 25, 2025Mansoura University
NCT06884657Phase 4Mar 20, 2025Cukurova University
NCT06768268Phase 1/Phase 2 (Phase 2)Jan 1, 2025National Taiwan University, National Yang Ming Chiao Tung University Hospital
NCT06473779Phase 3Sep 30, 2024AstraZeneca, Fortrea
NCT06540352Phase 2Jun 3, 2024Government of Russia
NCT06841406Phase 4May 1, 2024Katholieke Universiteit Leuven
NCT07064720Phase 2/Phase 3 (Phase 3)Apr 12, 2024Cairo University
NCT06304181N/AMar 15, 2024Zhejiang University
NCT06400355N/AMar 1, 2024Cairo University, National Cancer Institute, Egypt
NCT06105671N/ADec 15, 2023University of Copenhagen
NCT05979727Phase 1Nov 20, 2023Reconnect Labs, University of Zurich
NCT06846307Phase 3Nov 1, 2023Diponegoro University
NCT05761405Early Phase 1 (Phase 1)Oct 16, 2023Ecole Polytechnique Fédérale de Lausanne, University of Bern, University of Lausanne
NCT06004687Phase 1/Phase 2 (Phase 2)Jul 26, 2023Nantong University
NCT05912114N/AJun 10, 2023Ningbo No. 1 Hospital
NCT05740618Phase 4Mar 28, 2023Chiesi, University of North Carolina at Chapel Hill
NCT05305508Phase 2May 31, 2022OM Pharma, University of Geneva, University of Genoa
Showing 20 of 142 trials
Page 1 / 8

Organizations

Research & Development (184)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
SyntaraFor profit191642004
Harvard UniversityAcademic/Hospital6432000
Oregon Health and Science UniversityAcademic/Hospital5432004
National Cancer Institute (NCI)Government4022004
University of British ColumbiaAcademic/Hospital4432013
University of LausanneAcademic/Hospital4422013
Ain Shams UniversityAcademic/Hospital3332013
Cairo UniversityAcademic/Hospital3222012
Capital Medical UniversityAcademic/Hospital3222010
Institute of Liver and Biliary Sciences, IndiaAcademic/Hospital3312014
Istanbul UniversityAcademic/Hospital3312013
Katholieke Universiteit LeuvenAcademic/Hospital3132013
University of LondonAcademic/Hospital3122005
University of PennsylvaniaAcademic/Hospital3032000
University of SaskatchewanAcademic/Hospital3332011
University of TuebingenAcademic/Hospital3222009
University of ZurichAcademic/Hospital3032013
Utrecht UniversityAcademic/Hospital3212009
ACE Pharmaceuticals BVFor profit2012017
AstraZenecaFor profit2222012
184 organizations
Page 1 / 10

Marketing (19)

OrganizationOrg typeRelationshipDate
AbraxisFor profitMKTGJun 10, 1980
B. BraunFor profitNDA2Jul 30, 1964
BaxaltaFor profitNDA2Jun 8, 1964
BaxterFor profitNDA2Jun 8, 1964
ChiesiFor profitMKTGOct 30, 2020
ChiesiFor profitSYNOct 30, 2020
ChiesiFor profitNDA2Oct 30, 2020
FreseniusFor profitMKTGAug 11, 1972
HospiraFor profitNDA2Dec 22, 1967
HospiraFor profitMKTGAug 20, 1971
ICU Medical IncFor profitNDA2Feb 22, 1980
International MedicationFor profitMKTGAug 29, 1975
LutipoldFor profitMKTGJan 21, 1982
MerckFor profitNDA2—
Merck KGaAFor profitNDA—
MilesFor profitNDA2—
SyntaraFor profitNDA2Oct 5, 2010
Teligent PharmaceuticalsFor profitMKTGMay 6, 1987
Watson PharmaceuticalsFor profitMKTG—