Alprostadil
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | PROSTIN VR PEDIATRIC | — | 1987-07-10 | fda.gov ↗ |
| Approved | US (FDA) | PROSTIN VR PEDIATRIC | — | 1981-10-16 | fda.gov ↗ |
Trials 29 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 11 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02584686 Background | Oct 2015 → May 2016 | vasculogenic impotence | Cairo University | Completed | No outcome recorded |
| Phase 1 | NCT00572377 Comparator | May 2007 → Mar 2008 | sexual disorder | Cedars-Sinai Medical Center | Terminated | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02651350 Background | Dec 2015 → Jul 2019 | drug-induced liver injury | Beijing 302 Hospital | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT01810575 Comparator | Feb → Apr 2013 | erectile dysfunction | Warner Chilcott | Terminated | No outcome recorded |
| Phase 2 | NCT00080808 Comparator | Aug 2001 → Jul 2006 | prostate cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT00610051 Comparator | Oct 2026 → Nov 2029 expected | advanced heart failure, systolic heart failure | Biopeutics Co., Ltd | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT01245855 Comparator | Jan → Dec 2011 | — | First Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT03252626 Comparator | Apr → Dec 2024 | ischemic stroke | The First Hospital of Jilin University | Unknown | No outcome recorded |
| Phase 4 | NCT02331745 Background | Oct 2013 → Apr 2016 | alcoholic liver disease, hepatitis B virus infection, liver failure | Beijing 302 Hospital | Unknown | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06768177 Comparator | Apr 2023 → Nov 2024 overdue | erectile dysfunction | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari | Enrolling by invitation | No outcome recorded |
| — | NCT01378845 Comparator | Jul 2011 → Jun 2015 | Raynaud disease | Christoph Hehrlein | Unknown | No outcome recorded |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | alprostadil | “Standard treatment includes reduced glutathione, glycyrrhizin, ademetionine,polyene phosphatidylcholine, alprostadil, and human serum albumin) on the day of admission.” NCT02331745 ↗33“Drug (alprostadil/placebo - normal saline) to be nebulized; 5 micrograms via standard nebulizer within 4 hours, once.” NCT00314548 ↗ “including reduced glutathione, glycyrrhizin, ademetionine, alprostadil,or ursodeoxycholic acid (UDCA)” NCT02651350 ↗ “Safety and Efficacy of Alprostadil (FemLife Gel) in the Treatment of Female Sexual Arousal Disorder” NCT00572377 ↗ “ST-04 consists of an alprostadil polymer suspension designed for intraurethral application” NCT07601646 ↗ “Alprostadil, a prostaglandin E1 analog that has a vasodilator mechanism” NCT04536363 ↗ “20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine” NCT02584686 ↗ |
| Known as | caverject | “1 ml of caverject (alprostadil) 20 mcg” NCT06768177 ↗ |
| Known as | Eglandin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02350218 ↗ |
| Known as | FemLife Gel | “Safety and Efficacy of Alprostadil (FemLife Gel) in the Treatment of Female Sexual Arousal Disorder” NCT00572377 ↗ |
| Known as | lipo-PGE1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01245855 ↗ |
| Known as | Liprostin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00053716 ↗ |
| Known as | PGE1 | “Correction of the deficit in the perfusion pressure of the microcirculation that supplies the nerve by intravenous infusion of Prostaglandin E1 (PGE1) (Alprostadil), expected...” NCT03851562 ↗4“A number of clinical studies have proved that alprostadil (PGE1) has pharmacological effects of significant dilation of blood vessels, inhibition of plate aggregation,...” NCT03252626 ↗ “While the intravenous application PGE1, or alprostadil, can cause a decrease not only of the pulmonary but also of the systemic vascular tone” NCT00314548 ↗ “Prostaglandin E1 (alprostadil; PGE1)” PMID 35426776 ↗ Jul 2022 “Topical alprostadil (PGE-1)” NCT00324948 ↗ |
| Known as | Prostaglandin E1 | “Correction of the deficit in the perfusion pressure of the microcirculation that supplies the nerve by intravenous infusion of Prostaglandin E1 (PGE1) (Alprostadil), expected...” NCT03851562 ↗3“Alprostadil injection USP for intravascular infusion contains 500 micrograms Alprostadil, more commonly known as prostaglandin E1.” NCT03252626 ↗ “Prostaglandin E1 (alprostadil; PGE1)” PMID 35426776 ↗ Jul 2022 “Alprostadil (prostaglandin E1)” NCT00619229 ↗ |
| Known as | Prostaglandin E1 incorporated in lipid microspheres | “Prostaglandin E1 incorporated in lipid microspheres” NCT01245855 ↗ |
| Known as | Prostaglandin E2 | “Alprostadil (Prostaglandin E2) as adjuvant therapy” NCT04312555 ↗ |
| Known as | Prostavasin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01378845 ↗ |
| Known as | ST-04 | “This is a single arm dose escalation trial of a mucoadhesive intraurethral polymer suspension of alprostadil (ST-04) and will investigate the efficacy of 3 dose levels of ST-04...” NCT07601646 ↗ |
| Action | Inhibit | “Inhibition of platelets via PGE1 (Alprostadil)” NCT02895373 ↗ |
| Route | Intravenous | “a 12 hour intravenous infusion of Liprostin” NCT00053716 ↗ |