THERAPY DOSSIER · th-eaedd66040b6

Lipo-prostaglandin E1 (lipo-PGE1, alprostadil in lipid microsphere formulation)

Drug · Prostanoid EP1 receptor agonist; Prostanoid EP2 receptor agonist (AGONIST)

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Evidence & regulatory context

Mechanism: Prostanoid EP1 receptor agonist; Prostanoid EP2 receptor agonist (AGONIST)
Target: CHEMBL1811; CHEMBL1881
Injury models: Wound · Other
Reported indication: Alprostadil approved for erectile dysfunction and to maintain patent ductus arteriosus in neonates; first approval 1981
First approval: 1981
Development stage: Approved as alprostadil (ED, PDA); lipo-PGE1 myocardial-protection use investigational/regional
ChEMBL record: CHEMBL495 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: Prostaglandin E1; PGE1; Caverject; Prostin VR; Vitaros
Note: Not recorded

Clinical trials 3

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

NCT03159559 ↗PHASE4unknown

Lipo-PGE1 improves coronary microcirculation dysfunction in ischemic heart disease with diabetes

Coronary Microvascular Perfusion · Ischemic Heart Disease

Enrolment: 60 · Results not recorded

NCT03682952 ↗PHASE4unknown

Nail fold microcirculation and interventional therapy with alprostadil injection in chronic renal failure

Chronic Renal Disease

Enrolment: 100 · Results not recorded

NCT01245855 ↗PHASE3unknown

Protective effect of Lipo-PGE1 on myocardial injury following PCI

Prostaglandin E1 · Percutaneous Coronary Intervention

Enrolment: 100 · Results not recorded

Preclinical evidence 2

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

PMID 26198551 ↗2015Reported benefit

Effects of lipo-prostaglandin E1 on wound bed microcirculation.

RatWoundWistarMaleInjection (specific route not stated in the abstract)Medium dose 6 microgram/2 ml/kg; high dose 10 microgram/2 m…Administered after creation of the ear skin wound bed, with acute stimulation a…

Model: Microsurgical excision of the superficial stratum of the ear skin preserving the subdermal vascular plexus, creating a wound bed for intravital visualisation of microcirculation

Wound bed blood flow increased significantly 10 minutes after lipo-PGE1 injection (p<0.05), approximately fourfold above baseline, with the greatest increase in the medium-dose group; extravasation and accumulation of lipo-PGE1 in the wound bed were observed

Extraction: extract · Supplied extraction confidence: 0.72. Machine-extracted fields require source verification.

PMID 23242071 ↗2012Reported benefit

Co-administration of prostaglandin E1 with somatostatin attenuates acute liver damage after massive hepatectomy in rats via inhibition of inflammatory responses, apoptosis and endoplasmic reticulum stress.

RatOtherSprague-DawleyMalePre-treatment before hepatectomy

Model: Acute liver damage after 90% hepatectomy

Pre-treatment with prostaglandin E1 and somatostatin, particularly in combination, improved survival and reduced portal venous pressure, transaminases and inflammatory cytokines, inhibited apoptosis through upregulated Bcl-2 with downregulated Bax and caspase-3, and alleviated endoplasmic reticulum…

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

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