Delving into the Latest Updates on Nemolizumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-IL-31-receptor-monoclonal-antibody, IL-31RA monoclonal antibody, Nemolizumab (Genetical Recombination)

+ [14]

Target

IL-31RA

Action

inhibitors

Mechanism

IL-31RA inhibitors(interleukin 31 receptor A inhibitors)

Therapeutic Areas

Immune System DiseasesCongenital DisordersSkin and Musculoskeletal Diseases+ [6]

Active Indication

Moderate Atopic DermatitisSevere Atopic Dermatitisprurigo nodularis+ [5]

Inactive Indication-

Originator Organization

Chugai Pharmaceutical Co., Ltd.

Active Organization

Galderma Holding SAGalderma (UK) Ltd.Galderma International SAS

+ [5]

Inactive Organization

Galderma Research & Development SNC

Chugai Pharmaceutical Co., Ltd.

License Organization

Maruho Co., Ltd.

Chugai Pharmaceutical Co., Ltd.GALDERMA PHARMA SA

Drug Highest PhaseApproved

First Approval Date

Japan (28 Mar 2022),

Dermatitis, Atopic

RegulationBreakthrough Therapy (United States), Priority Review (United States)

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Structure/Sequence

Sequence Code 81291H

Source: *****

Sequence Code 1151753L

Source: *****

Atopic dermatitis (AD) is a common, heterogeneous inflammatory skin disease characterized by chronic or relapsing eczematous lesions and intense pruritus, leading to reduced quality of life and increased mental health burden. Despite recent therapeutic advances, moderate-to-severe AD remains challenging to manage, and conventional treatments often have limited long-term efficacy and safety concerns. Interleukin-31 (IL-31) is a key mediator in AD pathogenesis, driving pruritus, barrier dysfunction, type 2 inflammation, and fibrosis. Nemolizumab, a humanized monoclonal antibody targeting the IL-31 receptor α-chain (IL-31RA), has emerged as a novel therapeutic option.

MATERIALS AND METHODS:

This narrative review discusses current understanding of the role of IL-31 in AD pathophysiology. It also summarizes the most recent and relevant clinical trial data on the efficacy and safety of nemolizumab.

RESULTS:

Multiple phase II and III randomized clinical trials have demonstrated nemolizumab efficacy in patients with moderate-to-severe AD, with significant and sustained reductions in pruritus and overall disease severity. Furthermore, nemolizumab has shown a favorable safety profile, with most adverse events reported as mild and non-serious.

CONCLUSIONS:

IL-31 plays a critical role in the pathogenesis of atopic dermatitis. Findings from clinical trials support the efficacy and safety of nemolizumab in the treatment of moderate-to-severe AD.

11 Nov 2025·Cureus Journal of Medical Science

Concurrent Nemolizumab-Induced Cutaneous Adverse Events and Asthma Exacerbation in a Patient With Prurigo Nodularis With Resolution of Both Conditions After Switching to Dupilumab

Article

Author: Iozumi, Ken ; Mima, Yoshihito ; Yamamoto, Masako

Prurigo nodularis (PN) is a chronic pruritic inflammatory disease driven by Th2-dominant immune dysregulation and neural hyperactivity. Conventional therapies often fail, while biologics such as dupilumab and nemolizumab have shown efficacy. However, nemolizumab can cause cutaneous adverse events (cAEs) and occasional asthma exacerbation. An 82-year-old woman with long-standing PN and well-controlled asthma developed cAEs and asthma exacerbation one month after initiating nemolizumab, an IL-31 receptor antagonist. Although nemolizumab markedly improved pruritus and PN lesions, acute eczematous eruptions and erythematous papules appeared on previously unaffected skin, accompanied by worsening asthma symptoms. After switching to dupilumab (IL-4/IL-13 inhibitor), both cAEs and asthma improved, with complete resolution within two months. The mechanism underlying nemolizumab-induced cAEs and asthma remains unclear, but activation of Th2-driven inflammation following IL-31 blockade has been proposed. To our knowledge, this is the first reported case of concurrent nemolizumab-induced cAEs and asthma exacerbation in a patient with PN, successfully managed with dupilumab. Given that asthma exacerbations have occurred only in patients with preexisting asthma, careful monitoring is warranted when administering nemolizumab. Further studies are needed to clarify its mechanism and management strategies.

01 Nov 2025·INTERNATIONAL JOURNAL OF DERMATOLOGY

Nemolizumab as a Novel Therapeutic Option for Refractory Prurigo Chronica Multiformis: A Case Report

Letter

Author: Nakajima, Saeko ; Nakayama, Shota ; Kabashima, Kenji ; Yonekura, Satoru

89

News (Medical) associated with Nemolizumab

05 Jan 2026

·www.biospace.com

J&J Stops Mid-stage Eczema Trial as $1.25B Asset Misses Efficacy Mark

iStock, Sundry Photography J&J paid Numab Therapeutics $1.25 billion upfront for the asset in 2024 based on the belief that its dual mechanism of action could improve on existing therapies. Johnson & Johnson has stopped a Phase IIb trial testing a treatment for atopic dermatitis after interim data fell short of the efficacy bar to warrant the study’s continuation. The company designed the DUPLEX-AD proof-of-concept study to compare JNJ-95475939 (JNJ-5939) to placebo in 240 people with moderate-to-severe atopic dermatitis. J&J began the trial in late February 2025 to validate signs of efficacy that persuaded it to pay Numab Therapeutics $1.25 billion upfront for the asset in 2024. Ten months after starting the study, J&J said the results of a planned interim analysis met prespecified criteria for early termination of the study. The termination reflected the asset’s failure to meet the “high-bar efficacy” that J&J has set for its atopic dermatitis programs, the company said in statement on Dec. 26. J&J, which is yet to share data from the trial, bet that JNJ-5939’s dual mechanism of action could improve on the standalone efficacy of two validated targets. The bispecific antibody targets IL-4 and IL-31, a pair of Type II cytokines. IL-4—which has become a cornerstone target in indications including atopic dermatitis because of its role in inflammation—is targeted by Regeneron and Sanofi’s blockbuster autoimmune disease drug Dupixent. David Lee, global immunology therapeutic area head at J&J, explained the rationale for targeting IL-31 at a conference in November. Lee called IL-31 “a big driver of itch,” adding that single-target drugs aimed at the cytokine have shown “some modest efficacy” in atopic dermatitis. The FDA approved Galderma’s anti-IL-31 antibody Nemluvio in atopic dermatitis in December 2024. John Reed, executive vice president for innovative medicine R&D at J&J, said at a Morgan Stanley event in September that JNJ-5939’s bispecific mechanism was an attempt to “break through efficacy ceilings of the monotherapies.” With JNJ-5939 failing to meet J&J’s expectations, the company’s focus in atopic dermatitis will shift to other assets. For now, JNJ-7528 is the only other atopic dermatitis candidate in J&J’s public pipeline. J&J began a Phase I trial of the asset in 2024 and is planning to start enrolling participants in a Phase IIb study next month. However, the company has other molecules cooking. J&J paid $850 million in May 2024 to buy Proteologix for its atopic dermatitis programs. That deal gave J&J control of a bispecific that hits IL-13 and TSLP, the target of Amgen and AstraZeneca’s Tezspire. J&J said the bispecific was ready to enter Phase I when it struck the deal. Lee said in November that the program was “progressing at pace, getting into the clinic.” The drugmaker also has an exclusive license to Kaken Pharmaceutical’s STAT6 program. J&J struck a deal for the oral drug candidate in late 2024 and, at that stag,e was aiming to enter the clinic in 2025.

Phase 1Phase 2License out/inDrug Approval

19 Dec 2025

·www.drugs.com

Eczema Injectable Drug Provides Quick Itch Relief, Clinical Trial Results Show

FRIDAY, Dec. 19, 2025 — A recently approved injectable eczema drug provides quick itch relief to patients with the maddening skin disease, a new study says. Nemolizumab ( Nemluvio ) relieved itchiness within two days for three times as many patients as a placebo, researchers reported Dec. 16 in the Journal of the European Academy of Dermatology and Venereology . The drug also helped twice as many eczema patients sleep better within a couple of days, researchers said. “These new data reinforce our understanding of nemolizumab’s rapid onset of action in relieving itch and, in turn, improving sleep in patients living with atopic dermatitis and prurigo nodularis,” researcher Dr. Christophe Piketty said in a news release. He’s program head of therapeutic dermatology for the Swiss pharma company Galderma. Galderma, the developer of nemolizumab, funded the study. The U.S. Food and Drug Administration (FDA) approved nemolizumab in 2024 for treatment of moderate-to-severe atopic dermatitis, commonly known as eczema, as well as for itchy bumps that often appear alongside eczema in a condition called prurigo nodularis, according to Drugs.com . Eczema occurs due to immune system problems that hamper the skin’s defenses against allergens and irritants, the Cleveland Clinic says. A monoclonal antibody, nemolizumab targets a receptor which activates an inflammatory immune system chemical that drives itch and other symptoms in eczema, researchers said in background notes. For the new study, researchers performed a follow-up analysis of the clinical trial data that led to FDA approval of the drug. They reviewed data from trials involving nearly 2,300 people. Results showed that nemolizumab reduced itch within 48 hours for nearly 11% of patients, compared to 3% of patients taking a placebo. It also reduced itch that swiftly for 17% of patients with prurigo nodularis, compared to just under 4% of those on placebo. Sleep also improved within two days for 10% of eczema patients on nemolizumab compared to under 5% of those on a placebo, and more than 13% of prurigo nodularis patients compared to about 4% of those on placebo. By two weeks, a quarter of patients with eczema and more than a third with prurigo nodularis had shown clinically meaningful improvements in itch and sleep, the study said. “Itch is the most burdensome symptom reported by patients with moderate-to-severe atopic dermatitis and patients with prurigo nodularis, and rapid improvement in itch intensity is a key treatment goal,” researchers concluded. “Treatments that rapidly reduce itch and provide clinically meaningful improvements in disease severity and patients' quality of life are key in the current treatment landscape for both AD and PN,” they wrote. Sources Galderma, news release, Dec. 17, 2025 Journal of the European Academy of Dermatology and Venereology, Dec. 16, 2025

Clinical ResultDrug Approval

19 Dec 2025

·pmlive.com

Galderma’s Nemluvio rapidly relieves atopic dermatitis and prurigo nodularis symptoms

Galderma’s Nemluvio (nemolizumab) has shown rapid relief of itch, as well as improvement in sleep, in patients with atopic dermatitis (AD) and prurigo nodularis (PN). AD and PN are chronic skin conditions characterised by symptoms such as persistent itch, skin lesions and poor sleep. Itch – which can also cause sleep disturbance – is a symptom that significantly impacts quality of life in both conditions: 87% of patients with AD seek freedom from itch, and 88% of those with PN rate it as their worst symptom. Nemluvio is a monoclonal antibody designed to target the interleukin-31 (IL-31) receptor alpha, inhibiting the signalling of IL-31, a cytokine associated with itch and other symptoms of AD and PN. The results for Nemluvio come from the phase 3 ARCADIA and OLYMPIA clinical trials. ARCADIA, which was focused on AD, included more than 1,700 patients, while OLYMPIA, focused on PN, included 560 patients. Both studies found that Nemluvio reduced both itch and sleep disturbance: 10.7% of AD patients and 17.2% of PN patients found that Nemluvio reduced itch within two days, while 9.9% of AD patients and 13.4% of PN patients found that it reduced sleep disturbance within two days. By day 14, a quarter of patients with AD and more than a third of patients with PN had achieved significant and clinically meaningful responses in both itch and sleep. Christophe Piketty, author and global programme head, Therapeutic Dermatology at Galderma, said: “This new data reinforces our understanding of nemolizumab’s rapid onset of action in relieving itch and, in turn, improving sleep in patients living with AD and PN, as well as its role in targeting the IL-31 pathway.” Nemluvio is approved by the US FDA to treat adults with PN, and patients over 12 years of age with AD. It can also be used in combination with other therapies if the disease is not adequately controlled by these therapies. It is approved for AD and PN by various regulatory authorities around the world, including the EU and UK.

Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Nemolizumab

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External Link

KEGG	Wiki	ATC	Drug Bank
D11080	Nemolizumab	-	DB15252

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Moderate Atopic Dermatitis	United States	Galderma Laboratories LP	13 Dec 2024
Severe Atopic Dermatitis	United States	Galderma Laboratories LP	13 Dec 2024
prurigo nodularis	Japan	Maruho Co., Ltd.	26 Mar 2024
Dermatitis, Atopic	Japan	Maruho Co., Ltd.	28 Mar 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pruritus	Phase 3	United States	Galderma Holding SA	29 Dec 2021
Pruritus	Phase 3	Hungary	Galderma Holding SA	29 Dec 2021
Pruritus	Phase 3	Poland	Galderma Holding SA	29 Dec 2021
Pruritus	Phase 3	Spain	Galderma Holding SA	29 Dec 2021
CREST Syndrome	Phase 2	-	GALDERMA PHARMA SA	15 Dec 2025
Scleroderma, Diffuse	Phase 2	-	GALDERMA PHARMA SA	15 Dec 2025
Scleroderma, Systemic	Phase 2	Japan	Maruho Co., Ltd.	20 Apr 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04204616 (OLYMPIA LTE, Pubmed \| J Eur Acad Dermatol Venereol)	Phase 3	prurigo nodularis	508	Nemolizumab	syhlsonmia(xrwtexfxxh) = vymobwabch memhxidztm (dxknhluebw ) View more	Positive	17 Dec 2025
NCT03989206 (ARCADIA LTE, Pubmed \| J Eur Acad Dermatol Venereol)	Phase 2/3	Dermatitis, Atopic	1,062	Nemolizumab	hueatqsxts(dkojavaiaq) = The majority (92.6%) of treatment-emergent adverse events (TEAEs) were mild/moderate in severity; only 22.1% were considered related to nemolizumab. The most common (≥5.0%) TEAEs were COVID-19 (19.6%), nasopharyngitis (19.5%), atopic dermatitis (18.1%), upper respiratory tract infection (12.7%), headache (6.5%) and asthma (5.5%). bsaezntigm (xjldmegltf )	Positive	13 Oct 2025
				Placebo
NCT04365387 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	242	Nemolizumab (Nemolizumab)	lkrlvunhwz = lyngsvgvxx ufuvavitum (mfhvlsfssz, josjzzftda - uzreihvklg) View more	-	05 Jun 2025
				Placebo (Placebo)	lkrlvunhwz = ywgxodgddt ufuvavitum (mfhvlsfssz, owafhbohsz - tljjlscubu) View more
NCT03985943 (ARCADIA, Pubmed \| Patient)	Phase 3	Dermatitis, Atopic	73	Nemolizumab	zefkgbvrxo(qftqrltypz) = xzpeiksgcb mmgxoqjrjm (idgfpxayuq ) View more	-	13 May 2025
				Placebo	zefkgbvrxo(qftqrltypz) = amrndlwygn mmgxoqjrjm (idgfpxayuq ) View more
NCT05075408 (NIKAIA 1, CTgov)	Phase 2/3	Pruritus	258	Nemolizumab (Nemolizumab 30 mg)	ecybhqigvl = hjpkmhbdww rzussouhdg (dupuppwgef, csmksmiogc - pvwwromcjd) View more	-	20 Feb 2025
				Nemolizumab (Nemolizumab 60 mg)	ecybhqigvl = yeddqmrcpd rzussouhdg (dupuppwgef, ryxftftgiv - clvpabttyj) View more
NCT05405985 (CTgov)	Phase 1	-	192	Nemolizumab (Nemolizumab With AI)	gqnglibhgl(yewaibjisx) = upwkwokrun tpzdivyqfw (hynjyqyqdd, 2.34) View more	-	03 Jan 2025
				DCS+Nemolizumab (Nemolizumab With DCS)	gqnglibhgl(yewaibjisx) = pnuzxbtgbv tpzdivyqfw (hynjyqyqdd, 2.31) View more
NCT04562116 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	17	CYP 450 Substrates+Nemolizumab	wxacxsqhbl = lyzvdnaqaa hrsljpjjhp (bhksttjarz, kpisybrfrb - wuynrnweux) View more	-	05 Dec 2024
JPRN-jRCT2080225289 (Pubmed)	-	Dermatitis, Atopic	89	尼莫利珠单抗	cfausgjohe(ygofdnesiq) = mpvgpogouj vpbplcpjos (mbahuowjyd ) View more	Positive	28 Nov 2024
				安慰剂	cfausgjohe(ygofdnesiq) = crdgepcggn vpbplcpjos (mbahuowjyd ) View more
NCT04501666 (OLYMPIA 1, Pubmed \| JAMA Dermatol)	Phase 3	prurigo nodularis	286	Nemolizumab 30 mg	fjytxcbcgu(ffpetgfmbj) = esdkphhwwx rkkklqivbq (nsspmllhim, 6.7% - 22.6%) View more	Positive	27 Nov 2024
				Placebo	fjytxcbcgu(ffpetgfmbj) = xfcaisbgnq rkkklqivbq (nsspmllhim ) View more
NCT05052983 (CTgov)	Phase 3	prurigo nodularis	34	Nemolizumab (Nemolizumab)	zpgnezwgkn(jedrqmrhrp) = luizqbrxxa lhnvlrqhhx (fymyteqvaf, syneiybdoa - cilwpcrzev) View more	-	08 Oct 2024
				Placebo (Placebo)	zpgnezwgkn(jedrqmrhrp) = miqdnfyvgv lhnvlrqhhx (fymyteqvaf, lekruuukkw - pmwwvfbxwp) View more

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