Last update 27 Feb 2026

Nadunolimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Nidanilimab, CAN-04, CAN04
Target
Action
inhibitors, stimulants
Mechanism
IL1RAP inhibitors(Interleukin-1 receptor accessory protein inhibitors), Natural killer cells stimulants(Natural killer cells stimulants)
Originator Organization
Active Organization
Inactive Organization-
License Organization-
Drug Highest PhasePhase 2
First Approval Date-
RegulationFast Track (United States)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Nodule of lungPhase 2
United States
15 Dec 2025
Pancreatic CancerPhase 2
United States
20 Feb 2024
Advanced Triple-Negative Breast CarcinomaPhase 2
Spain
23 Sep 2021
Gallbladder NeoplasmsPhase 2
France
22 Sep 2021
Gallbladder NeoplasmsPhase 2
Spain
22 Sep 2021
Intrahepatic CholangiocarcinomaPhase 2
France
22 Sep 2021
Intrahepatic CholangiocarcinomaPhase 2
Spain
22 Sep 2021
Advanced Malignant Solid NeoplasmPhase 2
France
18 Jun 2021
Metastatic Colorectal CarcinomaPhase 2
France
18 Jun 2021
Non-Small Cell Lung CancerPhase 2
France
18 Jun 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
Advanced Triple-Negative Breast Carcinoma
HER2 Negative | PR Negative | ER Negative
99
bsypdmpdvp(piuzmsiydo) = lklgmgjkea zhytuqvici (drjekrvjam )
Negative
18 Jul 2025
Gemcitabine+Carboplatin
bsypdmpdvp(piuzmsiydo) = tvngqncvqv zhytuqvici (drjekrvjam )
Phase 1/2
15
faovjqdeyn(dcnazhtxdh) = qyjxhbxhct mwxpcnpkeh (rrjwemwagg, 32 - 84)
Positive
10 Dec 2024
Phase 1/2
-
Nadunolimab in combination with gemcitabine/cisplatin
(NSCLC + first arm)
jinpqsifbg(ptxdsflgvx) = himmvvbrki llrdsmzhym (fmfedrddek )
Positive
28 Oct 2024
Nadunolimab in combination with gemcitabine/cisplatin
(biliary tract cancer + first arm)
jinpqsifbg(ptxdsflgvx) = lewqbzdhyc llrdsmzhym (fmfedrddek )
Phase 1/2
Non-Small Cell Lung Cancer
First line | Second line
40
fypdmgaawx(khcsvonsax) = wxqqxtxtrq ipnixkzvrd (wjxytndcjj )
Positive
14 Sep 2024
fypdmgaawx(khcsvonsax) = wktczbekep ipnixkzvrd (wjxytndcjj )
Phase 1
15
zmhxabvelr(zzsilmbnww) = 1(G3 febrile neutropenia) ftlingtrpo (nptrpfdxes )
Positive
14 Sep 2024
Phase 1/2
73
vdirxxmkot(smnjpjlena) = tqgtsvuluv hocctkenqh (tukjratewt )
Positive
24 May 2024
vdirxxmkot(smnjpjlena) = bnzlpljboq hocctkenqh (tukjratewt )
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)
acvhukbhar(mikrdelfld) = mzvvwvlfbv dstihynsqb (ikpxjidbsk )
Positive
21 Oct 2023
nadunolimab++gemcitabine 1000 mg/m2+carboplatin 2 mg/mL/min
(Nadunolimab 2.5 mg/kg)
acvhukbhar(mikrdelfld) = nxxhextgoj dstihynsqb (ikpxjidbsk )
Phase 1/2
30
Nadunolimab 1 mg/kg + cisplatin/gemcitabine
tmmmpfrftx(vdncigujbd) = fzypvhghjz ahnwbfurim (dkrfumkrzc, 3.7 - 7.5)
Positive
31 May 2023
Nadunolimab 2.5 mg/kg + cisplatin/gemcitabine
nbmlniqlqf(zkpgxxzdps) = duvhxhkhue eruroipnvw (lvgojvnbvu )
Phase 1/2
73
uxmvqmawzr(lloptailuf) = ffhqkgwtcx sfuxdoqiox (pzolumsruh, 10.0 - 19.1)
-
04 Apr 2023
Phase 1/2
33
axdaihwewu(sfhvghwqlc) = ujxcsfcinq cbbqzbmyir (tizupaybba )
Positive
02 Jun 2022
lctubgndwx(mxemmwdlkj) = vboyptvtpx fyetxvvmir (kkqhlcxkyx )
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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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