Drugs / Rozanolixizumab
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed generalized myasthenia gravis 3 milestones | |||||
| Filed | US (FDA) | — | generalized myasthenia gravis | 2023-01-06 | “the U.S. Food and Drug Administration (FDA) has accepted the company’s filing to review a Biologic License Application (BLA) for its investigational treatment rozanolixizumab” ucb.com ↗ |
| Filed | EU (EMA) | — | generalized myasthenia gravis | — | “The FDA Priority Review designation follows the recent European Medicines Agency (EMA) validation of the Marketing Authorization Application (MAA) for rozanolixizumab” ucb.com ↗ “validation of the Marketing Authorization Application (MAA) for rozanolixizumab for the treatment of adults with AChR or MuSK antibody positive gMG” ucb.com ↗ |
| Filed | Japan (PMDA) | — | generalized myasthenia gravis | — | “Regulatory applications for rozanolixizumab and zilucoplan for the treatment of gMG have also been filed in Japan.” ucb.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Rystiggo | — | 2024-01-05 | europa.eu ↗ |
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06720714 | Dec 2024 → May 2025 | — | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 1 | NCT04828343 | Apr 2021 → Apr 2022 | — | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 1 | NCT03859219 | Mar 2019 → Apr 2020 | — | UCB Biopharma S.P.R.L. | Completed | No outcome recorded |
| Phase 1 | NCT02220153 | Jul 2014 → Sep 2015 | — | UCB Celltech | Completed | No outcome recorded |
| Phase 26 trials · 3 missed | ||||||
| Phase 2 | NCT05643794 | Dec 2022 → May 2024 | fibromyalgia | UCB Biopharma SRL | Completed | Missed primary |
| Phase 2 | NCT04875975 | Sep 2021 → Mar 2024 | limbic encephalitis with LGI1 antibodies | UCB Biopharma SRL | Terminated | No outcome recorded |
| Phase 2 | NCT04051944 | Aug 2019 → Nov 2021 | chronic inflammatory demyelinating polyradiculoneuropathy | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 2 | NCT03861481 | Mar 2019 → Mar 2021 | chronic inflammatory demyelinating polyradiculoneuropathy | UCB Biopharma S.P.R.L. | Completed | Missed primary |
| Phase 2 | NCT03052751 | May 2017 → May 2018 | generalized myasthenia gravis | UCB Biopharma S.P.R.L. | Completed | Missed primary |
| Phase 2 | NCT02718716 | Mar 2016 → Feb 2019 | thrombocytopenia | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06149559 | Jun 2024 → Aug 2026 overdue | generalized myasthenia gravis | UCB Biopharma SRL | Active not recruiting | No outcome recorded |
| Phase 311 trials · 2 met primary | ||||||
| Phase 3 | NCT07465289 | Jul 2026 → Jan 2031 expected | ocular myasthenia gravis | UCB Biopharma SRL | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07463521 | May 2026 → Dec 2028 expected | ocular myasthenia gravis | UCB Biopharma SRL | Recruiting | No outcome recorded |
| Phase 3 | NCT06540144 | Oct 2024 → Aug 2027 expected | generalized myasthenia gravis | UCB Biopharma SRL | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT05681715 | Apr 2023 → Apr 2024 | generalized myasthenia gravis | UCB Biopharma SRL | Completed | Met primary |
| Phase 3 | NCT05063162 | Feb 2022 → May 2027 expected | myelin oligodendrocyte glycoprotein antibody-associated disease | UCB Biopharma SRL | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04650854 | Feb 2021 → Jan 2024 | generalized myasthenia gravis | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 3 | NCT04596995 | Jan 2021 → Dec 2022 | primary thrombocytopenia | UCB Biopharma SRL | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04224688 | Jun 2020 → Apr 2022 | autoimmune thrombocytopenia | UCB Biopharma SRL | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04200456 | Jan 2020 → Mar 2022 | primary thrombocytopenia | UCB Biopharma SRL | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04124965 | Oct 2019 → Sep 2021 | generalized myasthenia gravis | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 3 | NCT03971422 | Jun 2019 → Aug 2021 | generalized myasthenia gravis | UCB Biopharma SRL | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT07246564 | Dec 2025 → Oct 2027 expected | generalized myasthenia gravis | UCB Biopharma SRL | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT05014724 Background | — | polyneuropathy, inflammatory demyelinating, chronic | UCB Biopharma SRL | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-07-08 | UCB Pharma | Results UCB presents latest data from its targeted generalized myasthenia gravis treatment portfolio at International Congress on Neuromuscular Diseases 2026 ucb.com ↗
Final pooled data from the Phase 3 MycarinG study and its open-label extension studies showed improvements across ocular signs and symptoms, alongside consistent benefits in bulbar, respiratory and limb weakness/gross motor function in adults living with gMG compared with placebo 1,2 |
| 2025-01-31 | UCB Pharma | Regulatory RYSTIGGO[®]▼(rozanolixizumab), for generalized myasthenia gravis (gMG), receives EU approval for two new administration methods ucb.com ↗
RYSTIGGO ® can now be self-administered, or administered by a caregiver, with an infusion pump or manual push with a syringe, after receiving training from a healthcare professional. |
| 2024-01-08 | UCB Pharma | Regulatory UCB announces European Commission approval of RYSTIGGO[®]▼ (rozanolixizumab) for the treatment of adults with generalized myasthenia gravis in Europe ucb.com ↗
Rozanolixizumab is the first therapy approved in Europe for adults with AChR or MuSK antibody-positive gMG, the two most common subtypes of gMG |
| 2023-11-10 | UCB Pharma | Regulatory UCB receives CHMP positive opinion for rozanolixizumab for treatment of adults with generalized myasthenia gravis in Europe ucb.com ↗ |
| 2023-09-25 | UCB Pharma | Regulatory UCB announces approval of RYSTIGGO[®] (rozanolixizumab) and ZILBRYSQ[®] (zilucoplan) for the treatment of adult patients with generalized myasthenia gravis in Japan ucb.com ↗ |
| 2023-06-27 | UCB Pharma | Regulatory UCB announces U.S. FDA approval of RYSTIGGO[®] (rozanolixizumab-noli) for the treatment of adults with generalized myasthenia gravis ucb.com ↗ |
| 2023-04-13 | UCB Pharma | Results UCB’s Rozanolixizumab and Zilucoplan Phase 3 Generalized Myasthenia Gravis studies published in prestigious The Lancet Neurology Journal ucb.com ↗
MycarinG study publication reports the clinically meaningful and statistically significant effects of rozanolixizumab across key endpoints in adult patients with acetylcholine receptor autoantibody positive (AChR-Ab+) or muscle-specific tyrosine kinase (MuSK-Ab+) autoantibody positive gMG, in the largest study in patients with gMG to date. |
| 2023-01-06 | UCB Pharma | Regulatory UCB announces rozanolixizumab BLA for the treatment of generalized myasthenia gravis filed with U.S. FDA and designated for Priority Review ucb.com ↗
UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s filing to review a Biologic License Application (BLA) for its investigational treatment rozanolixizumab, and that the Agency has granted Priority Review. |
| 2022-05-10 | UCB Pharma | Results UCB presents efficacy and safety results for zilucoplan and rozanolixizumab in generalized myasthenia gravis ucb.com ↗
Phase 3 RAISE and MycarinG studies in generalized myasthenia gravis (gMG) show zilucoplan and rozanolixizumab improve gMG-specific outcomes with consistent statistical significance and clinical relevance |
| 2021-12-10 | UCB Pharma | Results UCB announces positive Phase 3 results for rozanolixizumab in generalized myasthenia gravis ucb.com ↗
UCB, a global biopharmaceutical company, today announced positive topline results from the Phase 3 MycarinG study 1 evaluating rozanolixizumab, a subcutaneously (SC) infused monoclonal antibody targeting the neonatal Fc receptor (FcRn), versus placebo in adults with generalized myasthenia gravis (gMG). |
All press releases naming this drug 12 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Rozanolixizumab | “Rozanolixizumab (UCB7665; CA170_01519.g57 IgG4P) is an anti-human FcRn monoclonal antibody.” PMID 29093180 ↗ Nov 2017 |
| Known as | CA170_01519.g57 IgG4P | “Rozanolixizumab (UCB7665; CA170_01519.g57 IgG4P) is an anti-human FcRn monoclonal antibody.” PMID 29093180 ↗ Nov 2017 |
| Known as | Rozanolixizumab-noli | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297820 ↗ |
| Known as | Rystiggo | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297820 ↗ |
| Known as | UCB7665 | “Rozanolixizumab (UCB7665; CA170_01519.g57 IgG4P) is an anti-human FcRn monoclonal antibody.” PMID 29093180 ↗ Nov 2017 |
| Action | Inhibit | “Rozanolixizumab is a highly specific neonatal Fc receptor (FcRn) inhibitor that acts on immunoglobulin G (IgG) homeostasis.” PMID 38099334 ↗ Dec 20231“IgG receptor FcRn large subunit p51 inhibitor” CHEMBL4297820 ↗ |
| Modality | Monoclonal antibody | “is an anti-human FcRn monoclonal antibody” PMID 29093180 ↗ Nov 2017 |
| Route | Intravenous | “intravenous (IV) or subcutaneous (SC) rozanolixizumab” PMID 29093180 ↗ Nov 2017 |
| Route | Subcutaneous | “intravenous (IV) or subcutaneous (SC) rozanolixizumab” PMID 29093180 ↗ Nov 2017 |
| Target | FCGRT | “IgG receptor FcRn large subunit p51 inhibitor” CHEMBL4297820 ↗ |