Drugs / Nemolizumab
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed atopic eczema 5 milestones | |||||
| Filed | Other | — | atopic eczema | 2024-05-07 | “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...” galderma.com ↗ “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” galderma.com ↗ |
| Filed | US (FDA) | — | atopic eczema | 2024-02-14 | “On February 14, 2024, Galderma announced regulatory filing acceptances for nemolizumab in prurigo nodularis and atopic dermatitis in the U.S. and EU.” galderma.com ↗ |
| Filed | EU (EMA) | — | atopic eczema | 2024-02-14 | “The European Medicines Agency has also accepted Galderma’s Marketing Authorization Applications for nemolizumab in both prurigo nodularis and atopic dermatitis.” galderma.com ↗ “On February 14, 2024, Galderma announced regulatory filing acceptances for nemolizumab in prurigo nodularis and atopic dermatitis in the U.S. and EU.” galderma.com ↗ |
| Filed | Japan (PMDA) | — | atopic eczema | 2023-07-27 | “nemolizumab was also filed for approval in Japan for additional indication of prurigo nodularis, and pruritus associated with atopic dermatitis (pediatric)” chugai-pharm.co.jp ↗ |
| Filed | Japan (PMDA) | — | atopic eczema | 2020-10-22 | “a regulatory application was filed in Japan for nemolizumab, an anti-IL-31 receptor A antibody created by Chugai, for the treatment of atopic dermatitis by Maruho Co., Ltd.,...” chugai-pharm.co.jp ↗ |
| Filed prurigo nodularis 4 milestones | |||||
| Filed | Other | — | prurigo nodularis | 2024-05-07 | “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...” galderma.com ↗ “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” galderma.com ↗ |
| Filed | US (FDA) | — | prurigo nodularis | 2024-02-14 | “The U.S. Food and Drug Administration (FDA) has accepted Galderma’s Biologics License Applications for nemolizumab for the treatment of patients with prurigo nodularis” galderma.com ↗ “On February 14, 2024, Galderma announced regulatory filing acceptances for nemolizumab in prurigo nodularis and atopic dermatitis in the U.S. and EU.” galderma.com ↗ |
| Filed | EU (EMA) | — | prurigo nodularis | 2024-02-14 | “The European Medicines Agency has also accepted Galderma’s Marketing Authorization Applications for nemolizumab in both prurigo nodularis and atopic dermatitis.” galderma.com ↗ “On February 14, 2024, Galderma announced regulatory filing acceptances for nemolizumab in prurigo nodularis and atopic dermatitis in the U.S. and EU.” galderma.com ↗ |
| Filed | Japan (PMDA) | — | prurigo nodularis | 2023-07-27 | “nemolizumab was also filed for approval in Japan for additional indication of prurigo nodularis” chugai-pharm.co.jp ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Nemluvio | — | 2025-02-12 | europa.eu ↗ |
| Approved | US (FDA) | NEMLUVIO | — | 2024-08-12 | fda.gov ↗ |
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05405985 | Aug → Nov 2022 | — | Galderma R&D | Completed | No outcome recorded |
| Phase 212 trials · 3 met primary | ||||||
| Phase 2 | NCT07843420 | Nov 2026 → Nov 2028 expected | cholestasis, primary biliary cholangitis, primary sclerosing cholangitis | Mayo Clinic | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07704775 | Sep 2026 → Sep 2027 expected | vulvar lichen sclerosus | University of Texas Southwestern Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07660835 | Jun 2026 → Jul 2028 expected | atopic eczema | Galderma R&D | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07047690 | Feb 2026 → May 2028 expected | systemic sclerosis | Galderma R&D | Recruiting | No outcome recorded |
| Phase 2 | NCT07074977 | Oct 2025 → Sep 2026 overdue | — | Galderma R&D | Recruiting | No outcome recorded |
| Phase 2 | NCT05214794 | Apr 2022 → Jun 2024 | systemic sclerosis | Maruho Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04921345 | Jun 2021 → Apr 2025 | atopic eczema | Galderma R&D | Completed | No outcome recorded |
| Phase 2 | NCT04365387 | Mar 2020 → Jul 2023 | atopic eczema | Galderma R&D | Completed | No outcome recorded |
| Phase 2 | NCT03921411 | Apr 2019 → Aug 2020 | atopic eczema | Galderma R&D | Completed | No outcome recorded |
| Phase 2 | NCT03181503 | Oct 2017 → Sep 2018 | prurigo nodularis | Galderma R&D | Completed | Met primary |
| Phase 2 | NCT03100344 | Jun 2017 → Jul 2018 | atopic eczema | Galderma R&D | Completed | Met primary |
| Phase 2 | NCT01986933 | Nov 2013 → Apr 2015 | atopic eczema | Chugai Pharmaceutical | Completed | Met primary |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT05075408 | Mar 2022 → Jan 2024 | — | Galderma R&D | Completed | Missed primary |
| Phase 38 trials · 4 met primary | ||||||
| Phase 3 | NCT05056779 | Jan → Jul 2023 | atopic eczema | Galderma R&D | Withdrawn | No outcome recorded |
| Phase 3 | NCT05052983 | Jan 2022 → Sep 2023 | prurigo nodularis | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT04204616 | Jan 2021 → Oct 2026 expected | prurigo nodularis | Galderma R&D | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04501666 | Sep 2020 → Nov 2022 | prurigo nodularis | Galderma R&D | Completed | Met primary |
| Phase 3 | NCT04501679 | Aug 2020 → Mar 2022 | prurigo nodularis | Galderma R&D | Completed | Met primary |
| Phase 3 | NCT03989206 | Dec 2019 → Aug 2026 overdue | atopic eczema | Galderma R&D | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03989349 | Jun 2019 → Feb 2022 | atopic eczema | Galderma R&D | Completed | Met primary |
| Phase 3 | NCT03985943 | Jun 2019 → Dec 2021 | atopic eczema | Galderma R&D | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07396168 | Feb 2026 → Jun 2027 expected | lichen planopilaris | The Skin Center Dermatology Group | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT04562116 Background | Dec 2021 → Jun 2023 | atopic eczema | Galderma R&D | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 57
| Date | Issuer | Release |
|---|---|---|
| 2026-10-08 | Galderma R&D | Results Fall Clinical 2026: Galderma presents new three-year Nemluvio® data showing deep and lasting skin lesion and itch responses in patients with atopic dermatitis aged 12 and older galderma.com ↗
New Nemluvio® (nemolizumab) post-hoc data from the ARCADIA long-term extension (LTE) study showed the majority of Week 16 responders maintained deep and lasting skin lesion and itch response for up to three years1 |
| 2026-09-30 | Galderma R&D | Results EADV 2026: Galderma’s new data show sustained improvements with Nemluvio® (nemolizumab) for up to three years in patients with moderate-to-severe atopic dermatitis galderma.com ↗
New three-year ARCADIA long-term extension data demonstrate that Nemluvio is well-tolerated and associated with sustained and continuous improvements in skin lesions, itch, sleep disturbance and quality of life in adults and adolescents with moderate-to-severe atopic dermatitis1 |
| 2026-03-28 | Galderma R&D | Results AAD 2026: Late-breaking nemolizumab data demonstrate clinically meaningful benefits for children aged 2 to 11 with moderate-to-severe atopic dermatitis galderma.com ↗
Pharmacokinetics, safety and efficacy clinical study data show that nemolizumab achieved clinically meaningful reductions in skin lesions and itch through Week 16, which were sustained up to a year in children aged 2 to 11 with moderate-to-severe atopic dermatitis1 |
| 2026-02-27 | Galderma R&D | Results Galderma’s Nemluvio® (nemolizumab) demonstrates long-term disease control in prurigo nodularis up to three years galderma.com ↗
Results from an interim analysis of the OLYMPIA long-term extension (LTE) study show that Nemluvio maintained long-term disease control up to three years, with clinically meaningful improvements in itch intensity, skin lesions and quality of life1 |
| 2025-12-17 | Galderma R&D | Results New published data confirms Nemluvio® (nemolizumab) can rapidly relieve itch and improve sleep in as early as two days in both atopic dermatitis and prurigo nodularis galderma.com ↗
Galderma (SIX: GALD), the pure-play dermatology category leader, today released new clinical data confirming nemolizumab’s rapid onset of action on itch and sleep, with significant improvements observed as early as 48 hours after treatment in some patients with atopic dermatitis and prurigo nodularis. |
| 2025-09-03 | Galderma R&D | Results EADV 2025: scientific presentations supported by Galderma galderma.com ↗
Nemolizumab treatment did not impair immune response to vaccination in patients with atopic dermatitis – Results from a randomised, double-blind, placebo-controlled study |
| 2025-06-18 | Galderma R&D | Results ICD 2025: New data demonstrate Nemluvio®’s (nemolizumab) favorable safety profile and sustained and clinically meaningful improvements in symptoms of prurigo nodularis up to two years galderma.com ↗
The new data show Nemluvio is well tolerated and associated with sustained and clinically meaningful improvements in symptoms including itch and skin lesions, during prolonged treatment up to two years. |
| 2025-06-09 | Chugai Pharmaceutical | Results Galderma’s Announcement Regarding NEMLUVIO (New Long Term Data Presentation in Atopic Dermatitis) chugai-pharm.co.jp ↗
RAD 2025: Long-term data on Nemluvio ® (nemolizumab) demonstrate its favorable safety profile and sustained and increased improvements in itch and skin lesions in patients with atopic dermatitis up to two years |
| 2025-06-06 | Galderma R&D | Results RAD 2025: Long-term data on Nemluvio® (nemolizumab) demonstrate its favorable safety profile and sustained and increased improvements in itch and skin lesions in patients with atopic dermatitis up to two years galderma.com ↗
The data show that Nemluvio is well tolerated, with no new safety signals identified, reinforcing its rapid onset of action and demonstrating sustained and increased improvements in symptoms including itch and skin lesions with prolonged treatment up to two years. |
| 2025-02-18 | Galderma R&D | Regulatory Galderma’s Nemluvio® (nemolizumab) granted marketing authorization in the United Kingdom and Switzerland for moderate-to-severe atopic dermatitis and prurigo nodularis galderma.com ↗
Galderma today announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency and Swissmedic have granted the marketing authorization of nemolizumab for the treatment of both atopic dermatitis and prurigo nodularis in the UK and Switzerland, respectively. |
| 2025-02-17 | Chugai Pharmaceutical | Regulatory Galderma’s Announcement Regarding NEMLUVIO (EC Approval for the Treatment of Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis) chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that Galderma issued a press release on February 14 that they have received approval from the European Commission for NEMLUVIO ® (nemolizumab) for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis. |
| 2025-02-14 | Galderma R&D | Regulatory Galderma’s Nemluvio® (nemolizumab) approved in the European Union for moderate-to-severe atopic dermatitis and prurigo nodularis galderma.com ↗
Galderma today announced that the European Commission has approved Nemluvio for both moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union (EU). |
| 2024-12-16 | Chugai Pharmaceutical | Regulatory Galderma’s Announcement Regarding NEMLUVIO (FDA Approval for the Treatment of Moderate to Severe Atopic Dermatitis) chugai-pharm.co.jp ↗
the U.S. Food and Drug Administration (FDA) has approved the humanized anti-human IL-31 receptor A monoclonal antibody NEMLUVIO ® (nemolizumab) for the treatment of moderate to severe atopic dermatitis. |
| 2024-12-16 | Chugai Pharmaceutical | Regulatory Galderma’s Announcement Regarding Nemolizumab (CHMP Positive Opinion for the Treatment of Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis) chugai-pharm.co.jp ↗ |
| 2024-12-14 | Galderma R&D | Regulatory Galderma Receives U.S. FDA Approval for Nemluvio® (Nemolizumab) for Patients with Moderate-to-Severe Atopic Dermatitis galderma.com ↗ |
| 2024-12-13 | Galderma R&D | Regulatory CHMP recommends approval of Galderma’s nemolizumab for moderate-to-severe atopic dermatitis and prurigo nodularis in the European Union galderma.com ↗
Galderma today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting the marketing authorization of nemolizumab for the treatment of both atopic dermatitis and prurigo nodularis in the European Union (EU). |
| 2024-11-28 | Galderma R&D | Results Galderma’s phase III OLYMPIA 1 data published in JAMA Dermatology demonstrate that nemolizumab improves core signs and symptoms of prurigo nodularis galderma.com ↗
Galderma today announced that full results from the phase III OLYMPIA 1 trial, a 24-week study which evaluated the efficacy and safety of nemolizumab monotherapy in adults with moderate-to-severe prurigo nodularis, were published in JAMA Dermatology. |
| 2024-09-25 | Galderma R&D | Results EADV 2024 Late breaking news sessions: new Galderma data demonstrating nemolizumab’s long-term efficacy and safety in atopic dermatitis and durability in prurigo nodularis to be shared during three oral presentations galderma.com ↗
New 56-week data from an interim analysis of the phase III ARCADIA long-term extension study will be presented, with nemolizumab demonstrating a continuous improvement in clinically meaningful responses to signs and symptoms of atopic dermatitis for more than one year1 |
| 2024-09-17 | Galderma R&D | Results EADV 2024: scientific presentations supported by Galderma galderma.com ↗
Nemolizumab elicits an early and rapid itch response in prurigo nodularis within 2 days: A post hoc analysis of OLYMPIA 1 & 2 data |
| 2024-08-14 | Chugai Pharmaceutical | Regulatory Galderma’s Announcement Regarding Nemolizumab (FDA Approval for the Treatment of Prurigo Nodularis) chugai-pharm.co.jp ↗ |
| 2024-08-13 | Galderma R&D | Regulatory Galderma receives U.S. FDA approval for Nemluvio® (nemolizumab) for adult patients living with prurigo nodularis galderma.com ↗
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. |
| 2024-07-25 | Galderma R&D | Results Phase III Arcadia 1 and 2 trial primary results published in The Lancet: Galderma’s nemolizumab improves key aspects of atopic dermatitis – itch, skin lesions and sleep disturbance galderma.com ↗
Results show that the trials met their co-primary and all key secondary endpoints, showing that nemolizumab significantly improved skin lesions, itch and sleep disturbance by Week 16 when compared to placebo, with significant itch relief observed as early as Week 1. |
| 2024-05-07 | Galderma R&D | Regulatory Galderma receives filing acceptances for nemolizumab in prurigo nodularis and atopic dermatitis in four additional countries galderma.com ↗
Galderma today 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. |
| 2024-03-26 | Chugai Pharmaceutical | Regulatory Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials chugai-pharm.co.jp ↗
With this approval, the medicine may be used by children aged 6-12 years, in addition to the age group for which the brand has already been approved. |
| 2024-03-10 | Galderma R&D | Results Galderma @ AAD 2024: new data demonstrate the long-term efficacy of nemolizumab in prurigo nodularis and its durability in atopic dermatitis galderma.com ↗
One-year data from an interim analysis of the OLYMPIA long-term extension (LTE) study show that more than 80% of nemolizumab-treated patients with prurigo nodularis experienced improvement in itch and more than 60% achieved clear or almost-clear skin1 |
| 2024-02-28 | Galderma R&D | Results AAD 2024: scientific presentations supported by Galderma galderma.com ↗
Maintenance of efficacy and safety with nemolizumab* at Week 48: results from two global phase III pivotal studies (ARCADIA 1 and ARCADIA 2) in patients with moderate-to-severe atopic dermatitis |
| 2024-02-15 | Chugai Pharmaceutical | Regulatory Galderma Announces Updates on Nemolizumab Development chugai-pharm.co.jp ↗
It was announced by Galderma, that the European Medicines Agency (EMA) has also accepted the Marketing Authorization Applications for nemolizumab in prurigo nodularis and atopic dermatitis. |
| 2024-02-14 | Galderma R&D | Regulatory Galderma announces regulatory filing acceptance for nemolizumab in prurigo nodularis and atopic dermatitis in the U.S. and EU galderma.com ↗
The U.S. Food and Drug Administration (FDA) has accepted Galderma’s Biologics License Applications for nemolizumab for the treatment of patients with prurigo nodularis and for adolescents and adults with moderate to severe atopic dermatitis. |
| 2023-10-26 | Galderma R&D | Results Galderma phase III data published in The New England Journal of Medicine: full Olympia 2 trial results demonstrate nemolizumab’s rapid onset of action in patients with prurigo nodularis galderma.com ↗
The phase III OLYMPIA 2 trial in patients with prurigo nodularis met all primary and key secondary endpoints, showing nemolizumab monotherapy significantly and rapidly improves itch and skin lesions, with clinically meaningful improvements as early as week 4.1 |
| 2023-10-26 | Chugai Pharmaceutical | Results Galderma Announces Nemolizumab Data Published in the New England Journal of Medicine chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that Galderma issued a press release regarding the results of a Phase III clinical study (OLYMPIA 2) for prurigo nodularis of nemolizumab published in the New England Journal of Medicine (NEJM). |
| 2023-10-12 | Chugai Pharmaceutical | Results Galderma Announces Updates on Nemolizumab Development chugai-pharm.co.jp ↗
Galderma @ EADV 2023: phase III trials demonstrate nemolizumab’s efficacy and rapid onset of action in atopic dermatitis and prurigo nodularis |
| 2023-10-11 | Galderma R&D | Results Galderma @ EADV 2023: phase III trials demonstrate nemolizumab’s efficacy and rapid onset of action in atopic dermatitis and prurigo nodularis galderma.com ↗
Results from the phase III OLYMPIA 1 trial in patients with prurigo nodularis also met both primary endpoints and all key secondary endpoints, confirming nemolizumab’s rapid onset of action on itch. |
| 2023-07-04 | Galderma R&D | Results Galderma @ WCD 2023: late-breaking phase III results for nemolizumab monotherapy in prurigo nodularis show a significant proportion of itch-free patients by week 4 galderma.com ↗
The results highlight the rapid onset of action of nemolizumab monotherapy in patients with prurigo nodularis, with significantly more patients receiving the treatment achieving an itch-free state (indicated by a weekly average peak-pruritus numerical rating scale [PP-NRS] score <2) by week 4, vs. placebo (19.7% vs. 2.2%, p<0.0001). |
| 2023-06-28 | Galderma R&D | Results WCD 2023: Galderma’s scientific presentations galderma.com ↗
Patients with prurigo nodularis treated with nemolizumab achieved itch-free state: results from a phase 3 trial (OLYMPIA 2) |
| 2023-06-28 | Galderma R&D | Results WCD 2023: Galderma to present extensive data demonstrating enduring commitment to delivering innovative solutions in dermatology galderma.com ↗
Data from the pivotal phase III OLYMPIA 2 trial will be presented as a late-breaking abstract, demonstrating nemolizumab's rapidity of response in prurigo nodularis in the study[1] |
| 2023-03-18 | Galderma R&D | Results AAD 2023: Late-Breaking Phase III results demonstrate nemolizumab’s significant impact on prurigo nodularis galderma.com ↗
Galderma, the leading company solely dedicated to advancing the future of dermatology, today premiered the positive phase III results from the OLYMPIA 2 trial evaluating the efficacy, safety, pharmacokinetics and immunogenicity of nemolizumab compared with placebo in adult patients with prurigo nodularis. |
| 2023-03-17 | Galderma R&D | Results AAD 2023: Extensive updates from Galderma’s broad and innovative portfolio through posters and presentation sessions galderma.com ↗
Nemolizumab monotherapy improves itch, skin lesions and sleep disturbance in patients with prurigo nodularis: Results from a phase 3 trial (OLYMPIA 2) |
| 2022-06-22 | Galderma R&D | Results Galderma announces positive data from phase III trial, demonstrating efficacy and safety of nemolizumab in patients with prurigo nodularis galderma.com ↗
Galderma today announced the phase III OLYMPIA 2 trial met all primary and key secondary endpoints, showing nemolizumab as monotherapy significantly improved skin lesions and pruritus (itch) compared with placebo in adult patients with moderate to severe prurigo nodularis. |
| 2022-06-22 | Chugai Pharmaceutical | Results Galderma Announces Topline Results of OLYMPIA 2 Study Evaluating Nemolizumab in Prurigo Nodularis chugai-pharm.co.jp ↗ |
| 2022-03-28 | Chugai Pharmaceutical | Regulatory Maruho Obtained Regulatory Approval for Mitchga, the First Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis chugai-pharm.co.jp ↗ |
| 2022-03-25 | Galderma R&D | Results Galderma to highlight latest science and innovation across its product portfolio at the 2022 AAD Annual meeting galderma.com ↗
Nemolizumab is associated with a rapid reduction of itch and sleep disturbance in patients with prurigo nodularis |
| 2021-12-03 | Galderma R&D | Results Galderma announces new data demonstrating the positive anti-inflammatory effect and mode of action of nemolizumab in patients with moderate to severe Prurigo Nodularis galderma.com ↗
The results demonstrate that nemolizumab effectively decreases IL-31 responses in PN skin, leading to suppression of downstream inflammatory responses and improvement in lesions, pruritus and nerve function. |
| 2021-09-29 | Galderma R&D | Results Galderma presents new nemolizumab data at EADV reinforcing rapid onset of action and consistent relief of symptoms for people with prurigo nodularis and atopic dermatitis galderma.com ↗
Results from two key trials of nemolizumab given every 4 weeks, demonstrate rapid onset of action and significant reduction in symptoms for patients with prurigo nodularis (PN) and atopic dermatitis (AD), and new real-world evidence highlight the PN disease burden. |
| 2021-04-08 | Galderma R&D | Results Galderma announces publication of phase 2b trial results demonstrating the rapid and long-lasting benefits of nemolizumab in clinical trial subjects with uncontrolled atopic dermatitis galderma.com ↗
Galderma today announced that the Journal of the European Academy of Dermatology and Venereology (JEADV) has published full results from a post-hoc analysis of the phase 2b study of its investigational therapy, nemolizumab, in adult patients with moderate-to-severe atopic dermatitis (MtS AD). |
| 2020-07-09 | Chugai Pharmaceutical | Results Results of Maruho’s Phase III Study with Chugai’s Nemolizumab for Atopic Dermatitis Published in The New England Journal of Medicine Online chugai-pharm.co.jp ↗ |
| 2020-02-20 | Galderma R&D | Results Galderma Announces New England Journal of Medicine Publication from Phase 2 Study of Investigational Therapy Nemolizumab in Patients with Moderate to Severe Prurigo Nodularis galderma.com ↗
Nemolizumab met the primary endpoint of a greater improvement in Peak Pruritus Numerical rating scale (PP-NRS) from baseline to Week 4 compared to placebo. |
| 2020-02-20 | Chugai Pharmaceutical | Results Results of Phase II Study with Chugai’s Nemolizumab for Prurigo Nodularis Published in the New England Journal of Medicine Online chugai-pharm.co.jp ↗
Nemolizumab met the primary endpoint of a greater improvement in Peak Pruritus Numerical rating scale (PP-NRS) from baseline to Week 4 compared to placebo. |
| 2019-12-09 | Galderma R&D | Regulatory Galderma Investigational Therapy Nemolizumab Granted FDA Breakthrough Therapy Designation for the Treatment of Patients Suffering from Prurigo Nodularis galderma.com ↗
Galderma today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the investigational therapy nemolizumab for the treatment of pruritus associated with prurigo nodularis. |
| 2019-12-09 | Chugai Pharmaceutical | Regulatory Chugai’s Nemolizumab Receives FDA Breakthrough Therapy Designation for the Treatment of Pruritus Associated with Prurigo Nodularis chugai-pharm.co.jp ↗
The U.S. Food and Drug Administration granted Breakthrough Therapy Designation for nemolizumab, an investigational drug under development by Galderma, for the treatment of pruritus associated with prurigo nodularis |
| 2019-04-18 | Chugai Pharmaceutical | Results Nemolizumab Shows Positive Results in Maruho’s Phase 3 Study in Atopic Dermatitis chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that Maruho Co., Ltd. reported results from a phase 3 study investigating the efficacy and safety of nemolizumab (CIM331) with atopic dermatitis patients 13 years of age or older who had moderate-to-severe pruritus. |
| 2019-03-11 | Chugai Pharmaceutical | Results Galderma Presented Results from Phase 2b Study of Nemolizumab in Patients with Atopic Dermatitis at the 2019 AAD Annual Meeting Late-breaking Session chugai-pharm.co.jp ↗
The study met the primary endpoint of a greater improvement in Eczema Area and Severity Index (EASI) scores from baseline compared with placebo. |
| 2019-03-08 | Galderma R&D | Results Galderma Presented Final Results from Phase 2b Study of Nemolizumab in Patients with Moderate-to-Severe Atopic Dermatitis at the 2019 American Academy of Dermatology Annual Meeting Late-Breaking Session galderma.com ↗
This study met the primary endpoint of a greater improvement in Eczema Area and Severity Index (EASI) scores from baseline compared with placebo. |
| 2018-10-31 | Galderma R&D | Results Galderma Announces Positive Results from Phase 2b Study of Nemolizumab in Patients with Moderate-to-Severe Atopic Dermatitis galderma.com ↗
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. |
| 2018-10-31 | Chugai Pharmaceutical | Results Galderma Announces the Results of Phase 2b Study of Nemolizumab in Patients with Atopic Dermatitis chugai-pharm.co.jp ↗
Galderma Announces Positive Results from Phase 2b Study of Nemolizumab in Patients with Moderate-to-Severe Atopic Dermatitis |
| 2018-05-10 | Chugai Pharmaceutical | Results Chugai’s Anti-IL-31 Receptor A Humanized Monoclonal Antibody “nemolizumab,” Long Term Data from Global Phase II Study Published in Journal of Allergy and Clinical Immunology Online chugai-pharm.co.jp ↗ |
| 2017-03-02 | Chugai Pharmaceutical | Results Chugai’s Anti-IL-31 Receptor A Humanized Monoclonal Antibody “nemolizumab (CIM331)” Global Phase II Study Data Published in The New England Journal of Medicine Online chugai-pharm.co.jp ↗
The study was conducted to evaluate the safety and efficacy of nemolizumab in 264 patients with moderate-to-severe AD, and the safety and efficacy of nemolizumab at 12 weeks were confirmed. |
| 2016-03-06 | Chugai Pharmaceutical | Results Chugai Announces Phase II Global Study Results of Nemolizumab (CIM331) in Late-breaking Research Forums at AAD chugai-pharm.co.jp ↗
Efficacy and tolerability for 12 weeks treatment were observed in this study. |
All press releases naming this drug 69 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 29 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nemolizumab | “A Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis (PN)” NCT03181503 ↗ |
| Known as | CD14152 | “The purpose of this study is to assess the effect of nemolizumab (CD14152) on humoral immune responses to tetanus and meningococcal vaccination in adult and adolescent...” NCT04365387 ↗1“A Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis (PN)” NCT03181503 ↗ |
| Known as | CIM331 | “We wanted to assess the efficacy and safety of nemolizumab (CIM331), a humanized antibody against interleukin-31 receptor A” PMID 28249150 ↗ Mar 2017 |
| Known as | Nemluvio | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297794 ↗ |
| Known as | Nemolizumab-ilto | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07843420 ↗ |
| Action | Inhibit | “Nemolizumab, an interleukin (IL)-31 receptor subunit α antagonist, inhibits the IL-31 pathway of itch and skin inflammation in atopic dermatitis.” PMID 39067461 ↗ Jul 2024 |
| Modality | Monoclonal antibody | “Nemolizumab, an anti-IL-31 receptor A mAb” PMID 29753033 ↗ May 2018 |
| Route | Subcutaneous | “receive subcutaneous nemolizumab” PMID 28249150 ↗ Mar 2017 |
| Target | IL31RA | “Nemolizumab, an interleukin (IL)-31 receptor subunit α antagonist, inhibits the IL-31 pathway of itch and skin inflammation in atopic dermatitis.” PMID 39067461 ↗ Jul 2024 |