fospropofol
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | LUSEDRA | — | 2008-12-08 | fda.gov ↗ |
| Rejected (CRL) | US (FDA) | — | — | 2008-07-26 | “received a not approvable letter from the U.S. Food and Drug Administration (FDA), which outlines a pathway to potential approval of fospropofol disodium” eisai.com ↗ |
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01271569 | Mar → Sep 2010 | — | West China Hospital | Completed | No outcome recorded |
| Phase 26 trials · 1 missed | ||||||
| Phase 2 | NCT05870514 | Jun 2023 → Mar 2024 | — | Xiaobo Yang, MD | Unknown | Missed primary |
| Phase 2 | NCT05491278 | Aug 2022 → Jun 2023 | critical illness polyneuropathy | Xiaobo Yang, MD | Completed | No outcome recorded |
| Phase 2 | NCT00125398 | Jul 2005 → May 2007 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00209599 | Feb → Mar 2005 | polyp of colon | Eisai Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00209534 | Jan 2003 → Feb 2004 | colonic duplication, polyp of colon | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00209521 | Jun 2002 → Jul 2003 | coronary artery disorder | Eisai Inc. | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT00327392 | May 2006 → Dec 2007 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 2/3 | NCT00125424 | Jul → Sep 2005 | polyp of colon | Eisai Inc. | Completed | No outcome recorded |
| Phase 36 trials · 1 met primary | ||||||
| Phase 3 | NCT00306722 | Apr 2006 → May 2007 | — | Eisai Inc. | Completed | Met primary |
| Phase 3 | NCT00261599 | Mar → Oct 2006 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00209560 | Oct 2004 → Mar 2005 | carpal tunnel syndrome | Eisai Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00209586 | Sep 2004 → Mar 2005 | non-syndromic bridging bronchus | Eisai Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00209573 | Sep → Dec 2004 | polyp of colon | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00209547 | Feb 2004 → Mar 2005 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT07659132 | Jun → Sep 2026 overdue | urolithiasis | Shiyou Wei | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07333508 | Jan → Dec 2026 expected | — | Ya-Qun Zhou | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06573489 | Sep 2024 → Oct 2025 overdue | — | Hui Xu | Recruiting | No outcome recorded |
| Phase 4 | NCT06251999 | Aug 2024 → May 2027 expected | — | Shanghai 6th People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06344325 | May 2024 → Feb 2025 | — | Tongji Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01260142 | Nov 2010 → Feb 2011 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01401049 | Aug 2010 → Jul 2012 | — | NYU Langone Health | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT07788157 | Jul → Sep 2026 overdue | — | Tongji Hospital | Recruiting | No outcome recorded |
| — | NCT06732427 | Aug 2025 → Jun 2026 overdue | — | Affiliated Hospital of Nantong University | Recruiting | No outcome recorded |
| — | NCT01378754 | Jun 2011 → May 2014 | interstitial cystitis | Grace Shih, MD | Withdrawn | No outcome recorded Stop: Enrollment |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT01308541 Comparator | Jan → Aug 2011 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01309984 Comparator | Nov 2010 → Oct 2012 | lactation disease | Eisai Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01195103 Comparator | Feb → Mar 2011 | — | Mayo Clinic | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT01127438 Comparator | Apr 2010 → Jun 2011 | — | Eisai Inc. | Completed | No outcome recorded |
| — | NCT06261996 Comparator | Apr 2024 → Jul 2025 | — | Henan Provincial People's Hospital | Completed | No outcome recorded |
| — | NCT01289483 Comparator | Feb → Apr 2011 | — | The Cleveland Clinic | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2008-12-15 | Eisai Inc. | Regulatory FDA Approves Sedative-Hypnotic Agent LUSEDRA™ Injection eisai.com ↗
the U.S. Food and Drug Administration (FDA) has approved LUSEDRA™ (fospropofol disodium) Injection, an intravenous sedative-hypnotic agent for sedation in adult patients undergoing diagnostic or therapeutic procedures. |
| 2008-07-26 | Eisai Inc. | Regulatory Eisai Receives Action Letter on Fospropofol Disodium Injection For Sedation in Diagnostic or Therapeutic Procedures FDA's Not Approvable Letter Outlines Pathway to Potential Approval eisai.com ↗
today announced that it has received a not approvable letter from the U.S. Food and Drug Administration (FDA), which outlines a pathway to potential approval of fospropofol disodium for use by appropriately trained physicians. |
| 2008-05-08 | Eisai Inc. | Regulatory FDA ADVISORY COMMITTEE VOTES IN FAVOR OF APPROVAL OF FOSPROPOFOL DISODIUM INJECTION FOR SEDATION eisai.com ↗
The Committee recommended use of fospropofol disodium injection to health care providers who are appropriately trained. |
All press releases naming this drug 4 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 34 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fospropofol | “This is an exploratory clinical trial designed to examine the efficacy, safety and tolerability of fospropofol (AQUAVAN) Injection compared to propofol (DISOPRIVAN) Injectable...” NCT00209521 ↗23“E2083, or LUSEDRA® (fospropofol disodium) Injection, is an intravenous (IV) sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients...” NCT01309984 ↗ |
| Known as | AQUAVAN | “AQUAVAN (fospropofol disodium; GPI 15715 )” NCT00125398 ↗3“AQUAVAN® (fospropofol disodium) Injection” NCT00125424 ↗ “AQUAVAN® (fospropofol disodium) Injection” NCT00306722 ↗ “AQUAVAN® (fospropofol disodium) Injection” NCT00261599 ↗ |
| Known as | E2083 | “E2083, or LUSEDRA® (fospropofol disodium) Injection, is an intravenous (IV) sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients...” NCT01309984 ↗ |
| Known as | fospropofol disodium | “A Randomized, Open-label, 3 Period Crossover Study to Characterize the Pharmacokinetics and Pharmacodynamics of LUSEDRA (Fospropofol Disodium) Injection Administered Either by...” NCT01308541 ↗18“E2083, or LUSEDRA® (fospropofol disodium) Injection, is an intravenous (IV) sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients...” NCT01309984 ↗ “A Randomized, Open-Label, Single-Bolus, 2-Period, Multi-Dose Level, 3 Cohort Crossover Design, Pharmacokinetic/Pharmacodynamic Study of Lusedra (Fospropofol Disodium) Injection...” NCT01260142 ↗ “A Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special...” NCT01127438 ↗ “Fospropofol disodium is comparable to propofol in maintaining mild-to-moderate sedation for mechanically ventilated patients in intensive care unit (ICU).” PMID 40211146 ↗ Apr 2025 “Lusedra (fospropofol disodium), the water-soluble prodrug of propofol, does not cause pain on injection as it is water based medication.” NCT01401049 ↗ “Fospropofol disodium is a novel prodrug that has improved pharmacokinetic and pharmacodynamic properties compared with propofol” NCT06251999 ↗ “AQUAVAN (fospropofol disodium; GPI 15715 )” NCT00125398 ↗ “AQUAVAN® (fospropofol disodium) Injection” NCT00306722 ↗ “AQUAVAN® (fospropofol disodium) Injection” NCT00125424 ↗ “AQUAVAN® (fospropofol disodium) Injection” NCT00261599 ↗ |
| Known as | Fospropofol disodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201766 ↗ |
| Known as | Fospropofol sodium | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201766 ↗ |
| Known as | GPI 15715 | “AQUAVAN (fospropofol disodium; GPI 15715 )” NCT00125398 ↗ |
| Known as | Lusedra | “A Randomized, Open-label, 3 Period Crossover Study to Characterize the Pharmacokinetics and Pharmacodynamics of LUSEDRA (Fospropofol Disodium) Injection Administered Either by...” NCT01308541 ↗4“A Randomized, Open-Label, Single-Bolus, 2-Period, Multi-Dose Level, 3 Cohort Crossover Design, Pharmacokinetic/Pharmacodynamic Study of Lusedra (Fospropofol Disodium) Injection...” NCT01260142 ↗ “A Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special...” NCT01127438 ↗ “Lusedra (fospropofol disodium), the water-soluble prodrug of propofol, does not cause pain on injection as it is water based medication.” NCT01401049 ↗ “Group 1 will receive 6.5 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).” NCT01378754 ↗ |
| Modality | Small molecule | — CHEMBL1201766 ↗ |
| Route | Intravenous | “fospropofol IV infusion” PMID 21596879 ↗ May 2011 |