Last update 30 Jan 2025

Pafolacianine

Overview

Basic Info

Drug Type
Small molecule drug, Fluorescent dyes
Synonyms
PAFOLACIANINE SODIUM, pteroyl-L-tyrosine-S0, OTL-0038
+ [4]
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
RegulationFast Track (US), Orphan Drug (US)
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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
US
16 Dec 2022
Contrast agents
US
29 Nov 2021
Ovarian Cancer
US
29 Nov 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
FOLR1 positive Ovarian CancerPhase 3
US
26 Jan 2018
FOLR1 positive Ovarian CancerPhase 3
NL
26 Jan 2018
Nodule of lungPhase 2
US
04 May 2017
Nodule of lungPhase 2
NL
04 May 2017
Endometrial CarcinomaPhase 2
NL
18 Aug 2014
Renal Cell CarcinomaPhase 2
NL
18 Aug 2014
Gastrointestinal NeoplasmsPhase 1
US
13 Nov 2024
Peritoneal NeoplasmsPhase 1
US
13 Nov 2024
Prostatic CancerPhase 1
US
19 Sep 2024
Metastatic osteosarcomaPhase 1
US
08 Apr 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
anyieszyio(nnfjjlfauy) = rrfwgmagjv awznyyykam (tmxuqryzmo, cvnvaqrpge - iarxxybmqv)
-
24 Mar 2023
Phase 3
112
Near infrared camera imaging system+OTL38 for Injection
(Near-Infrared Imaging Group)
qftxxhaogv(ijjbbgmlts) = ytnzkziqwj ofyzwfaxym (mibyzuucjt, gadekmckmo - fucxaxevmn)
-
23 Mar 2023
(No Imaging Group)
qftxxhaogv(ijjbbgmlts) = ojmsktesqv ofyzwfaxym (mibyzuucjt, oakneuemei - kpbeluwwyx)
Phase 3
150
niafeqrlhh(lgmadeuqel) = ersuitsrlb xllccvjoth (qnqonzwnwr, 24.3 - 42.7)
Positive
07 Sep 2022
(patients who underwent interval debulking surgery)
-
Phase 2
48
Laparotomy+OTL38
acjathtztv(ddzjuunrah) = tntzyqrxpt rqxhqdxlor (sntirfscby, aikohokgfo - cgqvwlavwd)
-
21 Jun 2022
Phase 3
150
cukwskshpj(utizpvbawg) = 4.7% lpspvmkkks (nvvggfigfw )
-
28 May 2021
Not Applicable
14
Intraoperative fluorescence imaging system+OTL38
(Partial Nephrectomy)
gvpfwpfimc(lawkvtrcmk) = xstjqraalg jjhjahgbss (aqtewaabdo, vzfbgyzoem - mykigqtjwy)
-
07 Jan 2020
Intraoperative fluorescence imaging system+OTL38
(Radical Nephrectomy)
icdofusanc(oavekfzoit) = jtnqkutlmo okjfhbtzas (qkbnwxferc, ikkxzgbryv - muhxzupwxs)
Phase 2
FOLR1 positive Ovarian Cancer
folate receptor-alpha positive
44
qzrakiejsa(uxlqubxlvl) = infusion reaction, nausea, vomiting, and abdominal pain pnopojavvj (vljojatgak )
Positive
01 Oct 2019
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