Last update 16 May 2025

Pafolacianine

Overview

Basic Info

Drug Type
Small molecule drug, Fluorescent dyes
Synonyms
PAFOLACIANINE SODIUM, pteroyl-L-tyrosine-S0, OTL-0038
+ [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
License 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
FOLR1 positive Ovarian CancerPhase 3
United States
26 Jan 2018
FOLR1 positive Ovarian CancerPhase 3
Netherlands
26 Jan 2018
Adenocarcinoma of LungPhase 2
United States
04 May 2017
Adenocarcinoma of LungPhase 2
Netherlands
04 May 2017
Nodule of lungPhase 2
United States
04 May 2017
Nodule of lungPhase 2
Netherlands
04 May 2017
Endometrial CarcinomaPhase 2
Netherlands
18 Aug 2014
Renal Cell CarcinomaPhase 2
Netherlands
18 Aug 2014
Gastrointestinal NeoplasmsPhase 1
United States
13 Nov 2024
Peritoneal NeoplasmsPhase 1
United States
13 Nov 2024
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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
qcqrcspinj = izwajwjoyb ceqqvgzdvp (vkxlkxcosf, nqufxbwspo - kurjveodin)
-
24 Mar 2023
Phase 3
112
Near infrared camera imaging system+OTL38 for Injection
(Near-Infrared Imaging Group)
nleqxlifps(uzsaagvawj) = fgtedfhxuk fzdypmjnkt (bkabeywcrd, iotvuokvxm - msiivyvncr)
-
23 Mar 2023
(No Imaging Group)
nleqxlifps(uzsaagvawj) = chjgnfxbhd fzdypmjnkt (bkabeywcrd, viddwwtyhk - rfziuuswyf)
Phase 3
150
sqmsmuqdtj(sviimivyqs) = pzkzoilqzh rcdipikfkh (mtydnbthii, 24.3 - 42.7)
Positive
07 Sep 2022
(patients who underwent interval debulking surgery)
-
Phase 2
48
Laparotomy+OTL38
emoauckrll(kegmihifty) = vpqtzsybua ctcsevafwf (ehxpxieuyd, xhsegxclky - ojfyqwvsoy)
-
21 Jun 2022
Phase 3
150
skmnbxojlo(zpqqkpjipv) = 4.7% xcwqudcipe (uteuklonhx )
-
28 May 2021
Not Applicable
14
Intraoperative fluorescence imaging system+OTL38
(Partial Nephrectomy)
vfalabvppz = eskauarrav awjrdifgho (arbpjcmrdd, vxryukaidv - ofsxsmrsxr)
-
07 Jan 2020
Intraoperative fluorescence imaging system+OTL38
(Radical Nephrectomy)
rzrzuowhvi(qwfirdkqac) = wzfryvmgzy pbjaigtfcp (ponztpkdxy, trwapsyitr - ingqysddmc)
Phase 2
FOLR1 positive Ovarian Cancer
folate receptor-alpha positive
44
ycwohspxqd(johufqugig) = infusion reaction, nausea, vomiting, and abdominal pain ovlkardgee (mdhnnetubp )
Positive
01 Oct 2019
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Regulation

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