Drugs / Iferanserin
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT01355874 | Jul 2011 → Jun 2012 | internal hemorrhoid | Ventrus Biosciences, Inc | Terminated | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT01483833 Comparator | Sep 2001 → Aug 2002 | hemorrhoid | Ventrus Biosciences, Inc | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2012-06-25 | Assembly Biosciences | Results Ventrus Biosciences Announces Results From Pivotal Phase 3 Trial of Iferanserin (VEN 309) in Patients With Hemorrhoidal Disease assemblybio.com ↗
Ventrus Biosciences, Inc. (Nasdaq:VTUS) today reported that its Phase 3, randomized, double-blind, placebo-controlled clinical trial of iferanserin (VEN 309) in patients with hemorrhoidal disease did not meet its endpoints. |
| 2012-01-13 | Assembly Biosciences | Results Ventrus Announces Publication of Prior Phase 2b Study on the Safety and Efficacy of Iferanserin in the Treatment of Hemorrhoid Disease assemblybio.com ↗
Compared with placebo, iferanserin significantly reduced patient-reported severity of daily bleeding beginning at day 1 and itching beginning at day 2 ( P < 0.05). |
| 2011-06-22 | Assembly Biosciences | Regulatory Ventrus Receives SPA Response From FDA and Will Update and File the First Pivotal Trial Protocol to its IND assemblybio.com ↗
In its response, the FDA requested that additional information be included in the protocol pertaining to certain details of the trial. |
| 2011-03-18 | Assembly Biosciences | Regulatory Ventrus Announces Improved, FDA-Recommended Endpoints Proposed for Phase III Hemorrhoid Study assemblybio.com ↗
Ventrus submitted a new SPA on March 16, 2011 , that includes a revised protocol, including the newly defined endpoints, in accordance with the feedback received from that meeting, and expects a response within 45 days, which is the customary FDA review period. |
All press releases naming this drug 7 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Iferanserin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01483833 ↗ |
| Known as | Iferanserina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989686 ↗ |
| Known as | Iferanserine | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989686 ↗ |
| Known as | S-mpec | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989686 ↗ |
| Known as | Ven-309 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989686 ↗ |
| Action | Inhibit | “Iferanserin, a selective serotonin receptor antagonist” PMID 22244049 ↗ Jan 20121“Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL3989686 ↗ |
| Modality | Small molecule | — CHEMBL3989686 ↗ |
| Route | Other | “administered intra-anally twice daily (BID)” NCT01355874 ↗ |
| Target | HTR2A | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL3989686 ↗ |