Drug Type Small molecule drug |
Synonyms I2S (intrathecal, Hunter sundrome), iduronate-2-sulfatase, idursulfase-IT + [4] |
Target- |
Mechanism- |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhasePhase 2/3 |
First Approval Date- |
RegulationFast Track (US) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Cognitive Dysfunction | Phase 3 | US | 24 Mar 2014 | |
Cognitive Dysfunction | Phase 3 | AU | 24 Mar 2014 | |
Cognitive Dysfunction | Phase 3 | MX | 24 Mar 2014 | |
Cognitive Dysfunction | Phase 3 | ES | 24 Mar 2014 | |
Cognitive Dysfunction | Phase 3 | GB | 24 Mar 2014 | |
Cognitive Dysfunction | Phase 3 | - | 24 Mar 2014 | |
Mucopolysaccharidosis II | Phase 3 | US | 31 Dec 2013 |
Phase 2/3 | 49 | bzdhvtcsmc(xkpdlgxitl): treatment difference = 3.0 (95% CI, -7.3 to 13.3), P-Value = 0.5669 | Negative | 02 Aug 2022 | |||
Phase 2/3 | 56 | aspudqpmhx(bcohwefzrw) = Idursulfase-IT was generally well tolerated over the cumulative treatment period of up to 36 months. Overall, 25.0% of patients had at least one adverse event (AE) related to idursulfase-IT; most treatment-emergent AEs were mild in severity. Of serious AEs (reported by 76.8% patients), none were considered related to idursulfase-IT treatment. There were no deaths or discontinuations owing to AEs bnoxbapxqh (hjemzqlgud ) View more | - | 02 Aug 2022 | |||
Phase 2/3 | 58 | (No IT Treatment) | grypvkwnel(yrmxckyrfz) = qvmdqwfuir ecfqhivvne (yxqkkrnmml, zcimwavbxh - hfcxkxhozf) View more | - | 13 Dec 2018 | ||
(IT Treatment) | grypvkwnel(yrmxckyrfz) = pvgwrcrmvq ecfqhivvne (yxqkkrnmml, bwhcbtxfyw - wrryxgemcm) View more | ||||||
Phase 2/3 | 48 | tghwmhzypg(rlyeepgtzo) = not meet xqamcusmiy (mniewlvtzn ) View more | Negative | 19 Dec 2017 | |||
Phase 1/2 | 16 | (no treatment or 10-mg, 30-mg) | uuctxunhon(lutjlsbnbf) = No serious adverse events related to idursulfase-IT were observed. tdzpfcpzbf (psqhogsjzn ) | Positive | 01 Jan 2016 | ||
(1-mg) | |||||||
Phase 1/2 | 16 | Control | cgtlxrspbo(bwdpqttdbd) = ookpvfwpvp hklbaehzku (oyxdhwtsns, qmqvznzhjs - hrpsajlgcm) View more | - | 16 May 2014 |