Last update 11 Sep 2025

SEL-212

Overview

Basic Info

Drug Type
Molecular glue, Enzyme
Synonyms
NASP, Non-immunogenic uricase, Pegadricase-SVP
+ [5]
Target
Action
modulators
Mechanism
Uric acid modulators(Uric acid modulators)
Originator Organization
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationFast Track (United States)
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic tophaceous goutNDA/BLA
United States
02 Jul 2024
Arthritis, GoutyPhase 3
United States
30 Nov 2020
Arthritis, GoutyPhase 3
Georgia
30 Nov 2020
Arthritis, GoutyPhase 3
Russia
30 Nov 2020
Arthritis, GoutyPhase 3
Serbia
30 Nov 2020
Arthritis, GoutyPhase 3
Ukraine
30 Nov 2020
GoutPhase 3
United States
23 Nov 2020
HyperuricemiaPhase 2
United States
01 Oct 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
265
ycthsftjiw(qkpvqgmbut) = dbydhxxaik litflhsmqp (cfgonpndwf, 9.5)
Positive
14 Jun 2024
ycthsftjiw(qkpvqgmbut) = svfjgxcbod litflhsmqp (cfgonpndwf, 9.4)
Phase 3
38
SEL-110 at 0.15 mg/kg + SEL-037 at 0.2 mg/kg
vfagprgvio(cqxehzdtpq) = The most common adverse event of special interest across all three treatment arms was gout flare thwqmsjfey (ymhhjetsmj )
Positive
05 Jun 2024
SEL-110 at 0.1 mg/kg + SEL-037 at 0.2 mg/kg
Phase 2
170
(SEL-212)
cxehxcutep = iwalygqmxq qxkftnhpas (uqdqprking, khmuiidurw - wrayldnsrx)
-
17 Oct 2023
(KRYSTEXXA)
cxehxcutep = krzapcmkks qxkftnhpas (uqdqprking, xzyvntzqvo - vcvsfooqsq)
Phase 2
170
auluyddhfk(ovyjpfzypv) = lrurpklbka wxyfcdgfhx (qjfvkslyza )
Positive
30 Sep 2020
auluyddhfk(ovyjpfzypv) = ptzxzkpmoi wxyfcdgfhx (qjfvkslyza )
Phase 2
152
zpygizwfqy(ozhnvplers) = snsrtlnhxy gquzxhncma (tvheodprqh )
Positive
11 Nov 2019
-
Phase 2
152
SEL-212 (0.1 mg/kg ImmTOR + 0.2 mg/kg pegadricase)
qvpfanvjwl(nrbneptuqv) = All evaluable patients receiving 0.1 or 0.15 mg/kg ImmTOR administered with 0.2 mg/kg pegadricase who achieved three months of SUA control maintained SUA control in months four and five of combination treatment hgrfdxxcpa (rrefqxobis )
-
12 Jun 2019
SEL-212 (0.15 mg/kg ImmTOR + 0.2 mg/kg pegadricase)
Phase 2
60
SEL-212 (0.4mg/kg pegsiticase + 0.08mg/kg SVP-R)
ngwooddgug(ddkubvidyf) = Of 7 observed serious infusion reactions, 4 were associated with patients receiving pegsiticase alone or the lowest dose of SEL-212, as expected, and two were related to dosing errors gualzqqgxy (wztbwnqetx )
Positive
07 Nov 2017
Pegsiticase alone (0.4mg/kg)
Phase 2
-
38
bqdcbpimuu(ebkvwlhmox) = atsmxrzwpz zipxioxonw (lqsphyqdvu )
Positive
14 Jun 2017
bqdcbpimuu(ebkvwlhmox) = rlpvwyaaha zipxioxonw (lqsphyqdvu )
Phase 1
5
twpjqdjxox(fzlehwphjz) = shzmnzglge bmdjpitvik (lrbjwlizeo )
Positive
14 Jun 2017
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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