Drug Type Small molecule drug |
Synonyms Inovelon, Rufinamide (JAN/USP/INN), Xilep + [14] |
Target |
Mechanism SCNA modulators(Sodium channel alpha subunit modulators) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date EU (16 Jan 2007), |
RegulationOrphan Drug (US), Orphan Drug (JP), Orphan Drug (KR) |
Molecular FormulaC10H8F2N4O |
InChIKeyPOGQSBRIGCQNEG-UHFFFAOYSA-N |
CAS Registry106308-44-5 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D05775 | Rufinamide |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Lennox Gastaut Syndrome | EU | 16 Jan 2007 | |
Lennox Gastaut Syndrome | IS | 16 Jan 2007 | |
Lennox Gastaut Syndrome | LI | 16 Jan 2007 | |
Lennox Gastaut Syndrome | NO | 16 Jan 2007 | |
Seizures | EU | 16 Jan 2007 | |
Seizures | IS | 16 Jan 2007 | |
Seizures | LI | 16 Jan 2007 | |
Seizures | NO | 16 Jan 2007 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Epilepsy | NDA/BLA | US | - | |
Bipolar Disorder | Phase 2 | US | 05 Aug 2011 | |
Generalized anxiety disorder | Phase 2 | US | 01 Mar 2008 | |
Neuralgia | Phase 2 | CH | 21 Oct 1999 |
Phase 3 | Drug Resistant Epilepsy Add-on | 1,759 | Rufinamide + conventional AED | hzskxalsam(vnrjrluqzw): RR = 1.32 (95% CI, 0.36 - 4.86) View more | Positive | 08 Nov 2020 | |
Placebo + conventional AED | |||||||
Not Applicable | 183 | fpxxydfprk(vymyhsdhlz) = most often as fatigue gytvwnggta (fxborhoiem ) View more | Positive | 23 Jun 2019 | |||
Phase 3 | Lennox Gastaut Syndrome Add-on | 37 | ccndyyplar(efnnszzwzf) = zoxzrhgptd mynyaugpyd (xisjamtecf ) | - | 01 Jun 2019 | ||
Phase 3 | 54 | uzjzebfdsg(ucwssshqhq) = iorthvuatp tlufizktdk (lysrexunaw, stslsuyqmx - pcwlatujva) View more | - | 11 Mar 2019 | |||
Phase 2 | 239 | Placebo | lqovmzwkdl(hdbmdgsseb) = bzhiptqirk zwhhbrztdf (eydjuaqzpe, vwoyidjnlb - bycardwymw) View more | - | 23 Jan 2019 | ||
Phase 3 | Lennox Gastaut Syndrome Adjuvant | 37 | opydvdpnzr(efcusfqejj) = pcticqdjjm hljbwcboqx (tytjjcrxxo ) View more | Superior | 01 Jan 2019 | ||
investigator-chosen antiepileptic drug | opydvdpnzr(efcusfqejj) = lfjumyciii hljbwcboqx (tytjjcrxxo ) View more | ||||||
Phase 3 | - | Adjunctive Rufinamide | rswskmdeif(zwbipkkkqs) = vomiting and somnolence (022/304/303), decreased appetite (304), and pneumonia (303) were more common with rufinamide versus placebo/any-other-AED flhtynemsk (vbvuteraep ) View more | - | 10 Apr 2018 | ||
Placebo | |||||||
Phase 3 | - | eedyetmidd(ywmzfjdubh) = lsjfkgxnts kbafttoqgt (qzfywveghp ) | - | 10 Apr 2018 | |||
Not Applicable | 136 | vqfenxqlue(zjrsjzkmdd) = Asthenia was reported as a rare adverse event vegztvhjmz (riryortmpw ) View more | Positive | 05 Sep 2017 | |||
Phase 3 | 37 | sytxenazbq(tfowmhifqk) = ktifikdbvg mxzconnpzn (tfoeuqsmnz ) | - | 01 May 2016 |