Last update 20 Mar 2025

Nadunolimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Nidanilimab
Target
Action
inhibitors, stimulants
Mechanism
IL1RAP inhibitors(Interleukin-1 receptor accessory protein inhibitors), Natural killer cells stimulants(Natural killer cells stimulants)
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 2
First Approval Date-
Regulation-
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Colorectal CancerPhase 2
Spain
19 Sep 2017
Colorectal CancerPhase 2
Sweden
19 Sep 2017
Colorectal CancerPhase 2
Austria
19 Sep 2017
Colorectal CancerPhase 2
Lithuania
19 Sep 2017
Colorectal CancerPhase 2
Germany
19 Sep 2017
Colorectal CancerPhase 2
Belgium
19 Sep 2017
Colorectal CancerPhase 2
Denmark
19 Sep 2017
Colorectal CancerPhase 2
Latvia
19 Sep 2017
Colorectal CancerPhase 2
Netherlands
19 Sep 2017
Colorectal CancerPhase 2
Estonia
19 Sep 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
15
(hzmtyuyqoy) = oldxnmazvs eqsissnlzu (pwernqspvi, 32 - 84)
Positive
10 Dec 2024
Phase 1/2
-
Nadunolimab in combination with gemcitabine/cisplatin
(NSCLC + first arm)
(xnrhzwwych) = mbmhuxhsvv jwkdndwrjw (dectlbxddi )
Positive
28 Oct 2024
Nadunolimab in combination with gemcitabine/cisplatin
(biliary tract cancer + first arm)
(xnrhzwwych) = zjmjrfrsyf jwkdndwrjw (dectlbxddi )
Phase 1/2
Non-Small Cell Lung Cancer
First line | Second line
40
(lhboxdaxvg) = iwsrmummhl uczoojjhsv (uyqnwblwlm )
Positive
14 Sep 2024
(lhboxdaxvg) = grmzlwbhui uczoojjhsv (uyqnwblwlm )
Phase 1
15
(mkagedxsco) = 1(G3 febrile neutropenia) vwhwbkjmlr (qxlkpidcmw )
Positive
14 Sep 2024
Phase 1/2
73
lugazaxpmb(cdiigsoten) = whxevnvsap dyrervfyqw (wiiogxqjjn )
Positive
24 May 2024
lugazaxpmb(cdiigsoten) = fdzdymohay dyrervfyqw (wiiogxqjjn )
Phase 1/2
Triple Negative Breast Cancer
HER2 Negative | ER Negative | PR Negative
13
nadunolimab++gemcitabine 1000 mg/m2+carboplatin 2 mg/mL/min
(Nadunolimab 1 mg/kg)
(apfavcoolr) = jacuwbalrp ohcaibyllt (welylrofwm )
Positive
21 Oct 2023
nadunolimab++gemcitabine 1000 mg/m2+carboplatin 2 mg/mL/min
(Nadunolimab 2.5 mg/kg)
(apfavcoolr) = zzbnwcvfuc ohcaibyllt (welylrofwm )
Phase 1/2
30
Nadunolimab 1 mg/kg + cisplatin/gemcitabine
(ikxfetdzls) = wcahhwvjmx jstxywjczy (reiorsjvqx, 3.7 - 7.5)
Positive
31 May 2023
Nadunolimab 2.5 mg/kg + cisplatin/gemcitabine
prsrqsroyv(yldvewegaf) = uwazhwwpmi vfeagtvfgz (fuwrcqwdeh )
Phase 1/2
73
(kwvgnqmesp) = fkqcbtnzhh ruqsvoicim (yabwukdfkz, 10.0 - 19.1)
-
04 Apr 2023
Phase 1/2
76
(elrpknopfu) = Infusion-related reactions were reported in 29% (grade 3 in 3%). Peripheral sensory neuropathy was rare (only two grade 2 events). romcuabswt (fiokjrgnrn )
Positive
02 Jun 2022
Phase 1
15
(ghhjfqznmf) = ehoeaaxqdg cifvhirxao (krzwblekiw )
Positive
02 Jun 2022
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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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