Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 48 |
| INN | Nemolizumab |
| Status | Approved |
| Drug code(s) | CIM331, M5250B |
| Brand name | Mitchga, Nemluvio |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | IL-31R alpha |
| Indications of clinical studies | Systemic sclerosis, Chronic Kidney Disease Associated Severe Pruritus, Prurigo Nodularis, Atopic dermatitis, pruritus in dialysis patients |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved US, Japan |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 15, 2011 |
| Start of Phase 2 | December 15, 2013 |
| Start of Phase 3 | October 15, 2017 |
| Date BLA/NDA submitted to FDA | December 12, 2023 |
| Year of first approval (global) | 2022 |
| Date of first US approval | August 12, 2024 |
| INN, US product name | Nemolizumab, nemolizumab-ilto |
| US or EU approved indications | Treatment of adults with prurigo nodularis |
| Company | Chugai Pharmaceuticals |
| Licensee/Partner | Galderma Pharma, Maruho Co. Ltd. |
| Comments about company or candidate | August 13, 2024 – Galderma today announced that the U.S. Food and Drug Administration (FDA) has approved Nemluvio® (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis. BLA received a priority review. May 2024: Galderma announced that it has received filing acceptances for nemolizumab for the treatment of patients with prurigo nodularis and for adolescents and adults with moderate-to-severe atopic dermatitis in Australia, Singapore, Switzerland, and the United Kingdom, whose regulatory authorities are members of the Access Consortium. Aug 8 2022: Chugai Pharmaceutical Co., Ltd. announced that Maruho Co., Ltd. (hereafter, Maruho) launched the anti-IL-31 receptor A humanized monoclonal antibody Mitchga Subcutaneous Injection 60 mg Syringes [generic name: nemolizumab (genetical recombination)] for the treatment of itching associated with atopic dermatitis (Pruritus with atopic dermatitis (adults); only when existing treatment is insufficiently effective). Mitchga was approved by the Ministry of Health, Labour and Welfare (MHLW) on March 28, 2022 and listed on the national health insurance (NHI) reimbursement price list on May 25, 2022. March 28, 2022 - Maruho Co., Ltd. announces that it has received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for "Mitchga® Subcutaneous Injection 60mg Syringes" (Japanese Accepted Name (JAN): Nemolizumab (Genetical Recombination), hereinafter referred to as "the product"), for the treatment of itching associated with atopic dermatitis (only when existing treatment is insufficiently effective) in Japan. NCT05056779 Phase 3 in atopic dermatitis due to start in Jan 2022. Feb 2020: Galderma announced that the company is preparing for the initiation of a Phase III pivotal program with nemolizumab in adult patients with prurigo nodularis in 2020. Dec 2019: FDA grants Breakthrough Therapy Designation to nemolizumab for the treatment of pruritus associated with prurigo nodularis. Galderma is now actively preparing for the initiation of a Phase 3 pivotal program (NCT04204616) with nemolizumab in adult patients with prurigo nodularis in 2020. October 10, 2019: I Galderma announced that it has enrolled the first patients in a new Phase 3 clinical study with nemolizumab, an investigational therapy in adult patients with moderate-to-severe atopic dermatitis. NCT03985943 Phase 3 in atopic dermatitis started recruiting in June 2019. April 18, 2019: Maruho Co., Ltd. announces that a phase 3 clinical study (comparative study) of nemolizumab conducted in Japan for the treatment of pruritus associated with atopic dermatitis has achieved its primary endpoint. Maruho aims to apply for marketing approval in Japan, including the results of other clinical trials currently being conducted. NCT03921411 Phase 2 study in atopic dermatitis not yet recruiting as of April 19, 2019. October 31, 2018: Galderma, Nestlé Skin Health’s medical solutions business, today announced positive results from a Phase 2b dose-ranging study of nemolizumab in adult patients with moderate-to-severe atopic dermatitis (AD), a serious, chronic form of eczema. Galderma intents to start a Phase 3 study in 2019. JapicCTI-173740, A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-Center Study to Evaluate the Efficacy and Safety of nemolizumab in Japanese Atopic Dermatitis Patients with moderate to severe pruritus, started in Oct 2017. Nemolizumab, an investigational subcutaneous anti-IL-31 receptor A monoclonal antibody, met the primary endpoint of a greater improvement in Eczema Area and Severity Index (EASI) scores from baseline compared to placebo, and met secondary endpoints of major significance to Quality of Life improvement, such as Peak Pruritus Numerical Rating Scale (NRS) score vs. baseline for example. Phase 2 NCT03181503 study in Prurigo Nodularis due to start in Aug 2018 not yet recruiting as of Oct 19, 2018. In July 2016, Chugai entered into a global license agreement granting Galderma S.A. of Switzerland exclusive rights for the development and marketing of nemolizumab worldwide, with the exception of Japan and Taiwan. In September 2016, Chugai entered into a license agreement granting Maruho Co., Ltd., the rights for the development and marketing of nemolizumab in the skin disease area for the Japanese market. In development for AD, Galderma initiated global Phase III studies in 2019. Nemolizumab was granted breakthrough therapy designation by the U.S. FDA for pruritus associated with prurigo nodularis (PN). Galderma launched a Phase III clinical study for the treatment of PN in October 2020, while Maruho, started Phase II/III clinical studies in Japan in December 2020. |
| Full address of company | 1-1 Nihonbashi-Muromachi 2-Chome Chuo-ku, Tokyo 103-8324 JAPAN Asia Japan https://www.chugai-pharm.co.jp/english/rule/contact/index.html |
None
| Anticipated events | Regulatory review EU, Canada |
| Factor(s) contributing to discontinuation | None |