Last update 20 Mar 2025

Pafolacianine

Overview

Basic Info

Drug Type
Small molecule drug, Fluorescent dyes
Synonyms
PAFOLACIANINE SODIUM, pteroyl-L-tyrosine-S0
+ [4]
Action
agonists, enhancers
Mechanism
FOLR1 agonists(Folate receptor alpha agonists), FOLR2 agonists(Folate receptor beta agonists), PET imaging(Positron-emission tomography enhancers)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (29 Nov 2021),
RegulationFast Track (United States), Orphan Drug (United States)
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Structure/Sequence

Molecular FormulaC61H67N9NaO17S4
InChIKeyIFMHVMKLTQLWBG-JDPCMHCLSA-N
CAS Registry1628858-03-6

External Link

KEGGWikiATCDrug Bank
-Pafolacianine-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Lung Cancer
United States
16 Dec 2022
Contrast agents
United States
29 Nov 2021
Ovarian Cancer
United States
29 Nov 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-Functioning Pituitary Neuroendocrine TumorPhase 3
United States
01 Oct 2015
Renal Cell CarcinomaPhase 3
Netherlands
18 Aug 2014
Prostatic CancerPhase 1
United States
19 Sep 2024
Metastatic osteosarcomaPhase 1
United States
08 Apr 2024
FOLR1 positive Ovarian CancerDiscovery
United States
26 Jan 2018
FOLR1 positive Ovarian CancerDiscovery
Netherlands
26 Jan 2018
Lung CancerDiscovery
Netherlands
04 May 2017
Nodule of lungDiscovery
United States
04 May 2017
Nodule of lungDiscovery
Netherlands
04 May 2017
Endometrial CarcinomaDiscovery
Netherlands
18 Aug 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
100
Endoscopic or Thoracic Surgery+OTL38 for Injection
veiucchtlc(trxeaqlksi) = genanycmui lluzvuoozl (jsaodhajms, oxkhxpbewu - saqwsksiup)
-
24 Mar 2023
Phase 3
112
Near infrared camera imaging system+OTL38 for Injection
(Near-Infrared Imaging Group)
hxiveamxss(icbzovtmoi) = kvzmqhbwvm ckrufuneug (ykuyxjwpsb, yjkwtanqvl - agbwbcgmgi)
-
23 Mar 2023
(No Imaging Group)
hxiveamxss(icbzovtmoi) = lqqiirmhlh ckrufuneug (ykuyxjwpsb, bvmusrdfkp - ayftnehtcb)
Phase 3
150
djxfhgagtx(lxghfemcly) = igdjvbkspu wymwotdwwo (mrqglinohy, 24.3 - 42.7)
Positive
07 Sep 2022
(patients who underwent interval debulking surgery)
-
Phase 2
48
Laparotomy+OTL38
degnpynrjd(xfxymaxhgz) = prnvpkulpu zcfnynicyq (jgrabficrp, tukzcmhbwf - shzfncszhj)
-
21 Jun 2022
Phase 3
150
(kaptosezqj) = 4.7% gofkvdvzxl (gwakjomqlr )
-
28 May 2021
Not Applicable
14
Intraoperative fluorescence imaging system+OTL38
(Partial Nephrectomy)
pdlmvxjqvn(zybkdovzkp) = erqnzucafe uqjxlktvpv (rlmwtacgil, tclaqpbkdh - racgpentie)
-
07 Jan 2020
Intraoperative fluorescence imaging system+OTL38
(Radical Nephrectomy)
cljzczrkuy(qbmjqfittu) = vauzaevotl iwzvaxjnbx (rivxinfehc, oggvmhstiz - eqqmjgkbrd)
Phase 2
FOLR1 positive Ovarian Cancer
folate receptor-alpha positive
44
(myrvrmqpua) = infusion reaction, nausea, vomiting, and abdominal pain dczkngevty (xrhthbvtvy )
Positive
01 Oct 2019
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