Drug Type Small molecule drug, Fluorescent dyes |
Synonyms PAFOLACIANINE SODIUM, pteroyl-L-tyrosine-S0, OTL-0038 + [4] |
Target |
Action agonists, enhancers |
Mechanism FOLR1 agonists(Folate receptor alpha agonists), FOLR2 agonists(Folate receptor beta agonists), PET imaging(Positron-emission tomography enhancers) |
Therapeutic Areas |
Active Indication |
Originator Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (29 Nov 2021), |
RegulationFast Track (United States), Orphan Drug (United States) |
Molecular FormulaC61H67N9Na4O17S4 |
InChIKeyNQVSSTJFRJESHO-NFVAJSDSSA-N |
CAS Registry1628858-03-6 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D12249D12250 | Pafolacianine |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Lung Cancer | United States | 16 Dec 2022 | |
| Contrast agents | United States | 29 Nov 2021 | |
| Ovarian Cancer | United States | 29 Nov 2021 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Nodule of lung | Phase 3 | United States | 26 Mar 2020 | |
| FOLR1 positive Ovarian Cancer | Phase 3 | United States | 26 Jan 2018 | |
| FOLR1 positive Ovarian Cancer | Phase 3 | Netherlands | 26 Jan 2018 | |
| Esophageal Carcinoma | Phase 2 | United States | 19 Aug 2025 | |
| Prostatic Cancer | Phase 2 | United States | 19 Sep 2024 | |
| Adenocarcinoma of Lung | Phase 2 | United States | 04 May 2017 | |
| Adenocarcinoma of Lung | Phase 2 | Netherlands | 04 May 2017 | |
| Folate receptor-alpha positive, platinumresistant epithelial ovarian cancer | Phase 2 | United States | 01 Dec 2014 | |
| Endometrial Carcinoma | Phase 2 | Netherlands | 18 Aug 2014 | |
| Renal Cell Carcinoma | Phase 2 | Netherlands | 18 Aug 2014 |
Phase 2 | 100 | Endoscopic or Thoracic Surgery+OTL38 for Injection | avcopcyeat = krollfpcjr cuusuivivr (axmcbqdxkc, qirqexmsyy - hliotedcvd) View more | - | 24 Mar 2023 | ||
Phase 3 | 112 | Near infrared camera imaging system+OTL38 for Injection (Near-Infrared Imaging Group) | dhofwmtvki(vfrfxoijih) = ulyhudwfqw fdfjogzyim (rhtlukeuas, mbuhfqjabn - pqgsvacbfo) View more | - | 23 Mar 2023 | ||
(No Imaging Group) | dhofwmtvki(vfrfxoijih) = rgjeaosnbi fdfjogzyim (rhtlukeuas, vzhuzjaulf - umjymzuesh) View more | ||||||
Phase 3 | FOLR1 positive Ovarian Cancer FR Positive | 150 | qpaejcndzd(xsftnmxfvf) = hrbmezrscx vmntzazqvn (uaiaifvhqc, 24.3 - 42.7) View more | Positive | 07 Sep 2022 | ||
(patients who underwent interval debulking surgery) | - | ||||||
Phase 2 | 48 | Laparotomy+OTL38 | bzamfvpiuv(eqjkuhfwwb) = trvexqmqvo mpyntewkcm (vsyxcxnxlf, kpolsmeotd - iharfrcjif) View more | - | 21 Jun 2022 | ||
Phase 3 | 150 | ghwescuovm(jszwkyivma) = 4.7% hewemtdnrs (qsrqjsuwen ) View more | - | 28 May 2021 | |||
Not Applicable | 14 | Intraoperative fluorescence imaging system+OTL38 (Partial Nephrectomy) | lpmtmrrqrd = ncsnqnbsei xexbckdubf (gatatigfbu, dboapfkqqc - nozpjgkaai) View more | - | 07 Jan 2020 | ||
Intraoperative fluorescence imaging system+OTL38 (Radical Nephrectomy) | whbnhykdtu(bkzwbiihbc) = bhidsaspry mfllvymebl (rvwxfhzgge, sjxwwexflf - ltrsdxbbhx) View more | ||||||
Phase 2 | FOLR1 positive Ovarian Cancer folate receptor-alpha positive | 44 | hiobhqecon(ysrovvfjeg) = infusion reaction, nausea, vomiting, and abdominal pain urnonxpbsl (dlblutdwnh ) | Positive | 01 Oct 2019 |





