Drugs / LBEC0101
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01725620 | Nov 2012 → Apr 2013 | — | LG Life Sciences | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT02715908 | Apr 2016 → Dec 2017 | rheumatoid arthritis | LG Life Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02357069 | Feb 2015 → Dec 2016 | rheumatoid arthritis | LG Life Sciences | Unknown | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2018-05-30 | Mochida Pharmaceutical Company, Ltd. | Regulatory エタネルセプトBS「MA」の薬価基準収載ならびに新発売のお知らせ mochida.co.jp ↗ |
| 2018-01-19 | Mochida Pharmaceutical Company, Ltd. | Regulatory エタネルセプトのバイオ後続品の国内における製造販売承認取得のお知らせ mochida.co.jp ↗ |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-05-30 | Mochida Pharmaceutical Company, Ltd. | エタネルセプトBS「MA」の薬価基準収載ならびに新発売のお知らせ mochida.co.jp ↗ |
| 2018-01-19 | Mochida Pharmaceutical Company, Ltd. | エタネルセプトのバイオ後続品の国内における製造販売承認取得のお知らせ mochida.co.jp ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LBEC0101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01725620 ↗ |
| Known as | Etanercept | “BACKGROUND: To evaluate the long-term efficacy, safety and immunogenicity of continuing LBEC0101; the etanercept (ETN) biosimilar; or switching from the ETN reference product...” PMID 31113455 ↗ May 20191“LBEC0101 (Etanercept 25mg)” NCT01725620 ↗ |
| Modality | Protein / enzyme biologic | “LBEC0101 (etanercept biosimilar)” PMID 29259050 ↗ Dec 2017 |
| Route | Subcutaneous | “a single dose of LBEC0101 or Enbrel® was subcutaneously injected at 25 mg” PMID 28551775 ↗ Aug 2017 |