THERAPY DOSSIER · th-8ddc47bed173

2,3-O desulfated heparin (ODSH)

Drug

Evidence & regulatory context

Mechanism: Not recorded
Target: Not recorded
Injury models: TBI · Burn
Reported indication: Not recorded
First approval: Not recorded
Development stage: In trials, not approved
ChEMBL record: CHEMBL3990006 ↗
ChEMBL max phase: 3 / 4 (development scale, not regulatory approval)
Synonyms: ODSH; GM-1892; CX-01; Dociparstat sodium
Note: Not recorded

Clinical trials 10

2 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT04389840 ↗Injury indicationPHASE3terminated

Dociparstat sodium for severe COVID-19 in adults at high risk of respiratory failure

COVID-19 · Acute Lung Injury · SARS-CoV-2

Enrolment: 27 · Results not recorded

NCT02164097 ↗Injury indicationPHASE1terminated

ODSH in accelerating platelet recovery in paediatric recurrent solid tumour patients on ICE chemotherapy

Recurrent Solid Tumor · Sarcoma · Wilms' Tumor · Neuroblastoma

Enrolment: 4 · Results not recorded

NCT04571645 ↗PHASE3terminated

Dociparstat sodium with standard chemotherapy in newly diagnosed acute myeloid leukemia

Acute Myeloid Leukemia

Enrolment: 9 · Results not recorded

NCT00457951 ↗PHASE2terminated

Intravenous 2-O,3-O desulfated heparin (ODSH) in exacerbations of COPD

Chronic Obstructive Pulmonary Disease

Enrolment: 158 · Results not recorded

NCT02873338 ↗PHASE2completed

CX-01 combined with standard induction therapy for newly diagnosed AML

Acute Myeloid Leukemia

Enrolment: 75 · Results not recorded

NCT01461915 ↗PHASE2terminated

Gemcitabine + Abraxane with or without ODSH as first line treatment of metastatic pancreatic cancer

Metastatic Pancreatic Cancer

Enrolment: 60 · Results not recorded

NCT01161641 ↗PHASE1terminated

IV ODSH for exacerbation of protein losing enteropathy after single ventricle palliative surgery

Protein Losing Enteropathy

Enrolment: 5 · Results not recorded

NCT02995655 ↗PHASE1completed

CX-01 combined with azacitidine in relapsed or refractory MDS and AML

Myelodysplastic Syndromes · Acute Myeloid Leukemia

Enrolment: 20 · Results not recorded

NCT02056782 ↗PHASE1completed

ODSH in accelerating platelet recovery during induction/consolidation therapy for AML

Acute Myeloid Leukemia

Enrolment: 12 · Results not recorded

NCT01843634 ↗EARLY_PHASE1completed

ODSH in patients receiving induction or consolidation therapy for AML

Acute Myeloid Leukemia

Enrolment: 10 · Results not recorded

Preclinical evidence 2

2 studies reported at therapy level; 2 evidence entries itemised.

PMID 29373460 ↗2018Reported benefit

Early low-anticoagulant desulfated heparin after traumatic brain injury: Reduced brain edema and leukocyte mobilization is associated with improved watermaze learning ability weeks after injury.

MouseTBIControlled cortical impactCD1Malen = 66 mice in total; intravital microscopy series n = 46 (13,…Subcutaneous injection25 mg/kg or 50 mg/kg; vehicle 0.9% saline 1 mL/kgFirst dose 2 hours after controlled cortical impact

Model: Severe controlled cortical impact traumatic brain injury; 4 mm left craniotomy, 3 mm impactor tip, 6 m/s, 1.0 mm cortical deformation

Both doses reduced pial leukocyte rolling and albumin leakage and improved Garcia scores at 48 hours, 50 mg/kg reduced injured hemisphere oedema, and 25 mg/kg improved probe trial memory 17 days after injury.

Extraction: extract · Subtype source: rule · Supplied extraction confidence: 0.94. Machine-extracted fields require source verification.

PMID 21391301 ↗2011Reported benefit

Efficacy of desulfated heparin mitigating inflammation in rat burn wound model.

RatBurnUnspecifiedWistarFemaletopical (microspheres in collagen matrix dressing)on burn wound

Model: burn wound

Controlled delivery of 2,3-desulfated heparin regulated inflammatory events and hastened burn wound healing.

Extraction: extract · Supplied extraction confidence: 0.75. Machine-extracted fields require source verification.

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