Drugs / Botulinum Toxin Type B
Botulinum Toxin Type B
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | MYOBLOC | — | 2019-08-20 | fda.gov ↗ |
| Approved | EU (EMA) | NeuroBloc | — | 2001-01-22 | europa.eu ↗ |
| Approved | US (FDA) | MYOBLOC | — | 2000-12-08 | fda.gov ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02008136 | Mar 2016 → Aug 2018 | — | VA Connecticut Healthcare System | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00238641 | Jan 2002 → May 2005 | cerebral palsy | Stanford University | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03007004 | Dec 2016 → May 2019 | systemic sclerosis | Gunma University | Completed | No outcome recorded |
| Phase 2 | NCT00515437 | Jul 2007 → Jun 2008 | — | Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00165776 | Jun 2004 → May 2006 | cervical dystonia | Eisai Inc. | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT04815967 | Nov 2021 → Apr 2023 | cerebral palsy, multiple sclerosis, spinal cord injury, stroke disorder +1 | Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC | Terminated | No outcome recorded Stop: Business |
| Phase 2/3 | NCT04099667 | Dec 2019 → Mar 2023 | — | Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC | Terminated | No outcome recorded Stop: Business |
| Phase 2/3 | NCT00125203 | Jul 2003 → Aug 2007 | amyotrophic lateral sclerosis | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05097079 | Nov 2021 → May 2023 | — | Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT02610868 | Oct 2015 → Jun 2017 | — | Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC | Completed | No outcome recorded |
| Phase 42 trials · 1 missed | ||||||
| Phase 4 | NCT00208091 | Apr 2003 → May 2008 | focal dystonia | Columbia University | Completed | Missed primary |
| Phase 4 | NCT00702754 | Jun 2001 → May 2008 | cervical dystonia | Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT01930604 Comparator | Sep 2013 → Oct 2019 | isolated hyperchlorhidrosis | Carl Swartling | Unknown | No outcome recorded |
| Phase 3 | NCT01994109 Comparator | Nov 2013 → Jan 2016 | — | Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC | Completed | No outcome recorded |
| Phase 4 | NCT02052024 Comparator | May 2014 → Aug 2015 | brain injury, neoplasm, spinal cord injury, stroke disorder | Georgetown University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2011-01-21 | Eisai Inc. | Regulatory EISAI RECEIVES APPROVAL TO MARKET BOTULINUM TOXIN TYPE B NEUROMUSCULAR-BLOCKING AGENT NERBLOC® INTRAMUSCULAR INJECTION 2500 UNITS IN JAPAN eisai.com ↗
Eisai Co., Ltd. (Headquarters: Eisai, President & CEO: Haruo Naito) announced today that it has received approval to market the botulinum toxin type B neuromuscular-blocking agent NerBloc® Intramuscular Injection 2500 Units (generic name: botulinum toxin type B, “NerBloc”) in Japan for the treatment of cervical dystonia in adults. |
All press releases naming this drug 5 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | botulinum toxin type B | “MYOBLOC (rimabotulinumtoxinB) Injection, or botulinum toxin type B, is the "B" serotype of botulinum toxin.” NCT01994109 ↗ |
| Known as | MYOBLOC | “Biological: Botulinum Toxin Type B (Myobloc)” NCT00515437 ↗9“NeuroBloc/Myobloc (rimabotulinumtoxinB)” NCT01930604 ↗ “Botulinum toxin type B (Myobloc)” NCT00125203 ↗ |
| Known as | NeuroBloc | “NeuroBloc/Myobloc (rimabotulinumtoxinB)” NCT01930604 ↗ |
| Known as | rimabotulinumtoxinB | “MYOBLOC (rimabotulinumtoxinB) Injection, or botulinum toxin type B, is the "B" serotype of botulinum toxin.” NCT01994109 ↗ |
| Modality | Protein / enzyme biologic | “single intraglandular treatment with botulinum toxin type B” PMID 21887710 ↗ Sep 2011 |
| Route | Intramuscular | “intramuscularly administering to patients with spasmodic torticollis” NCT00165776 ↗ |