Drugs / Temoporfin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Foscan | — | 2001-10-24 | europa.eu ↗ |
| Rejected (CRL) | US (FDA) | Foscan® | SCC, head and neck cancer | — | “approval for the treatment of SCC and head and neck cancer but approval was declined in the US.” inviongroup.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01854684 | Feb 2014 → Sep 2018 | non-small cell lung carcinoma | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT01637376 | Jul 2012 → Jan 2014 | non-small cell lung carcinoma | University of Arkansas | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 24 trials | ||||||
| Phase 2 | NCT03003065 | Mar 2014 → Apr 2023 | hilar cholangiocarcinoma | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT01415986 | Nov 2010 → Aug 2011 | head and neck squamous cell carcinoma | University of Arkansas | Terminated | No outcome recorded |
| Phase 2 | NCT01016002 | Jan 2006 → Dec 2011 | bile duct carcinoma | University of Salzburg | Unknown | No outcome recorded |
| Phase 2 | NCT00003856 | Oct 1998 → ? | head and neck cancer | Quintiles, Inc. | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01718223 | Dec 2013 → Aug 2014 | oropharynx squamous cell carcinoma, tongue cancer, verrucous carcinoma of oral cavity | Roswell Park Cancer Institute | Withdrawn | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Temoporfin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01016002 ↗ |
| Modality | Other / unclassified | “Meso-tetrahydroxyphenylchlorin (mTHPC, Foscan®) is a photosensitizer for PDT in cholangiocarcinoma.” NCT03003065 ↗ |
| Route | Intravenous | “Patients receive IV temoporfin on day -4, followed by laser light therapy on day 0.” NCT00003856 ↗ |