nemolizumab
Approved
Aug 12, 2024
Nemolizumab, sold under the brand name Nemluvio, is a humanized monoclonal antibody used for the treatment of prurigo nodularis and atopic dermatitis. It is a monoclonal antibody that blocks the interleukin-31 receptor A. Nemolizumab is humanized IgG2 monoclonal antibody that inhibits interleukin-31 signaling by binding selectively to interleukin-31 receptor alpha. It is an interleukin-31 receptor antagonist. IL-31 is a cytokine involved in pruritus, inflammation, epidermal dysregulation and fibrosis. By inhibiting IL-31-induced responses, nemolizumab prevents the release of proinflammatory cytokines and chemokines. — Wikipedia
Clinical trial activity
20 trials · 3 clinical orgs · 2 marketing orgs
Earliest trial started Nov 1, 2013 (NCT01986933)
Timeline
Indications
Approved for
Mechanism of action
- Interleukin-31INHIBITOR
IL31 inhibitor
Interleukin-31 receptor subunit alpha inhibitor
Approval history
- approvedPriority reviewBreakthroughAug 12, 2024
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaNemolizumab ↗
- ChEMBLCHEMBL4297794 ↗
Also known as
- cim331
- nemolizumab
- nemolizumab
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07047690 | Phase 2 | Dec 15, 2025 | Galderma |
| NCT07074977 | Phase 2 | Sep 30, 2025 | Galderma |
| NCT05405985 | Phase 1 | Aug 11, 2022 | Galderma |
| NCT05214794 | Phase 2 | Apr 20, 2022 | Maruho Co., Ltd. |
| NCT05052983 | Phase 3 | Jan 31, 2022 | Galderma |
| NCT05056779 | Phase 3 | Jan 31, 2022 | Galderma |
| NCT05075408 | Phase 2/Phase 3 (Phase 3) | Dec 31, 2021 | Galderma |
| NCT04921345 | Phase 2 | Jun 24, 2021 | Galderma |
| NCT04562116 | Phase 2 | Oct 12, 2020 | Galderma |
| NCT04501666 | Phase 3 | Sep 11, 2020 | Galderma |
| NCT04501679 | Phase 3 | Aug 11, 2020 | Galderma |
| NCT04204616 | Phase 3 | Apr 1, 2020 | Galderma |
| NCT04365387 | Phase 2 | Mar 5, 2020 | Galderma |
| NCT03989349 | Phase 3 | Jun 30, 2019 | Galderma |
| NCT03985943 | Phase 3 | Jun 30, 2019 | Galderma |
| NCT03989206 | Phase 3 | Jun 28, 2019 | Galderma |
| NCT03921411 | Phase 2 | Apr 9, 2019 | Galderma |
| NCT03181503 | Phase 2 | Aug 28, 2017 | Galderma |
| NCT03100344 | Phase 2 | Jun 1, 2017 | Galderma |
| NCT01986933 | Phase 2 | Nov 1, 2013 | Chugai |
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Galderma | For profit | 18 | 18 | 3 | 2017 |
| Chugai | For profit | 1 | 1 | 1 | 2013 |
| Maruho Co., Ltd. | For profit | 1 | 1 | 1 | 2022 |