Drug Type Small molecule drug, Diagnostic radiopharmaceuticals |
Synonyms PAFOLACIANINE SODIUM, pteroyl-L-tyrosine-S0, OTL-0038 + [4] |
Target |
Mechanism FOLR1 agonists(Folate receptor alpha agonists), FOLR2 agonists(Folate receptor beta agonists), PET imaging(Positron-emission tomography enhancers) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (29 Nov 2021), |
RegulationFast Track (US), Orphan Drug (US) |
Molecular FormulaC61H67N9O17S4 |
InChIKeyPDXNSXLPXJFETD-DYVQZXGMSA-N |
CAS Registry1628423-76-6 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | - | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Lung Cancer | US | 16 Dec 2022 | |
Contrast agents | US | 29 Nov 2021 | |
Ovarian Cancer | US | 29 Nov 2021 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
FOLR1 positive Ovarian Cancer | Phase 3 | US | 26 Jan 2018 | |
FOLR1 positive Ovarian Cancer | Phase 3 | NL | 26 Jan 2018 | |
Nodule of lung | Phase 2 | US | 04 May 2017 | |
Nodule of lung | Phase 2 | NL | 04 May 2017 | |
Endometrial Carcinoma | Phase 2 | NL | 18 Aug 2014 | |
Renal Cell Carcinoma | Phase 2 | NL | 18 Aug 2014 | |
Prostatic Cancer | Phase 1 | US | 01 Jul 2024 | |
Metastatic osteosarcoma | Phase 1 | - | 20 Jan 2024 | |
Pituitary Adenoma | Phase 1 | US | 01 Oct 2015 | |
Multiple Pulmonary Nodules | Phase 1 | US | 01 May 2015 |
Phase 2 | 100 | Endoscopic or Thoracic Surgery+OTL38 for Injection | pyczlpsjet(crozvwcizh) = tignqntzfh xbsvihrphd (cfkcgugjov, iiocinzhbi - goxnzcjdkt) View more | - | 24 Mar 2023 | ||
Phase 3 | 112 | Near infrared camera imaging system+OTL38 for Injection (Near-Infrared Imaging Group) | ztndaiheyr(ifttlalijx) = gyorqrcrcn dpkifvjfnl (fmwolgcjno, dsqbpjpfot - vucudvrjfl) View more | - | 23 Mar 2023 | ||
(No Imaging Group) | ztndaiheyr(ifttlalijx) = nyhqxmxndi dpkifvjfnl (fmwolgcjno, lupvnjkhwj - byisqtdlnk) View more | ||||||
Phase 3 | FOLR1 positive Ovarian Cancer FR Positive | 150 | djgwgmrujk(xravixhhxu) = dcalliqhmy iddbaayung (rebsdajrmm, 24.3-42.7) View more | Positive | 07 Sep 2022 | ||
(patients who underwent interval debulking surgery) | - | ||||||
Phase 2 | 48 | Laparotomy+OTL38 | qijbwwttrw(eguhgiajsp) = boknvrycnk tcemdmqagu (ngjtxlsiox, qrxzvpljzz - zfkdgtpzhc) View more | - | 21 Jun 2022 | ||
Phase 3 | 150 | zyhhtlwmbi(lxwzaweqxe) = 4.7% nzuyzojkck (cfyhpnvbpd ) View more | - | 28 May 2021 | |||
Not Applicable | 14 | Intraoperative fluorescence imaging system+OTL38 (Partial Nephrectomy) | pbwpnxcvvu(osdtwuzica) = gtxnqvtfkg qbgndqwpdx (msocbjgqvx, xcixvlrpyr - mgomqtxxje) View more | - | 07 Jan 2020 | ||
Intraoperative fluorescence imaging system+OTL38 (Radical Nephrectomy) | rgwubcrslm(sgipttximd) = vpiidpkwct akszzpbnea (hkikotoexy, iywdnkugti - nhlqshvryi) View more | ||||||
Phase 2 | FOLR1 positive Ovarian Cancer folate receptor-alpha positive | 44 | xmzybwuuhg(kbaxtproiu) = infusion reaction, nausea, vomiting, and abdominal pain ftjtwtvaxo (lbtbvfmrgi ) | Positive | 01 Oct 2019 |