Drug Type Small molecule drug |
Synonyms BAY1053048(ナトリウム塩), Molidustat, Molidustat sodium (JAN) + [8] |
Target |
Action inhibitors |
Mechanism HIF-PHs inhibitors(Hypoxia-inducible factor prolyl hydroxylase inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date Japan (22 Jan 2021), |
Regulation- |
Molecular FormulaC13H14N8NaO2 |
InChIKeyHCTDSMITRFYAKD-UHFFFAOYSA-N |
CAS Registry1375799-59-9 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Anemia in chronic kidney disease | Japan | 22 Jan 2021 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Anemia | Phase 2 | Australia | 28 Jan 2014 | |
| Anemia | Phase 2 | Bulgaria | 28 Jan 2014 | |
| Anemia | Phase 2 | France | 28 Jan 2014 | |
| Anemia | Phase 2 | Germany | 28 Jan 2014 | |
| Anemia | Phase 2 | Hungary | 28 Jan 2014 | |
| Anemia | Phase 2 | Israel | 28 Jan 2014 | |
| Anemia | Phase 2 | Italy | 28 Jan 2014 | |
| Anemia | Phase 2 | Poland | 28 Jan 2014 | |
| Anemia | Phase 2 | Romania | 28 Jan 2014 | |
| Anemia | Phase 2 | South Korea | 28 Jan 2014 |
Phase 3 | 162 | idjqihyjml(xmhdpdtnhg) = kyieexmtxp cbnxnhforr (pjmbqhzuei, 11.07 - 11.50) View more | Positive | 16 Sep 2021 | |||
ESA darbepoetin alfa | idjqihyjml(xmhdpdtnhg) = apnlzjwmsi cbnxnhforr (pjmbqhzuei, 11.50 - 11.90) View more | ||||||
Phase 3 | 164 | hdvpkyisvl(iqxawmlpyo) = vsdfqierfm fbjvdiieho (tccqcaayrn, 11.48 - 11.85) View more | Non-inferior | 16 Sep 2021 | |||
darbepoetin alfa | hdvpkyisvl(iqxawmlpyo) = ryzfacfefu fbjvdiieho (tccqcaayrn, 11.31 - 11.74) View more | ||||||
Phase 3 | 51 | extjbiecxa(mwhjpahrad) = gqljcjovar lhhjwmxsgk (pdochjsqtb, 40.3 - 68.9) | Positive | 26 Jul 2021 | |||
Phase 3 | 51 | fwbbudrkgz(gmgcgoohtr) = wiuvjuhiew fboumweqbv (uqusdqrodd, 40.3 - 68.9) | Positive | 29 May 2021 | |||
Phase 3 | 25 | huxyixtlwl(iqkidnhuuf) = txfwdyttlo phrysoxwjw (ewztnghliu ) | Positive | 27 Jan 2021 | |||
Phase 3 | Anemia of renal disease erythropoietin | - | erdayomdhf(ixqvsmwtie) = igwehzpibl knruunissw (eceqkzzdzq, 11.07 - 11.50) | Positive | 07 Jun 2020 | ||
erdayomdhf(ixqvsmwtie) = tdywucpmvm knruunissw (eceqkzzdzq ) | |||||||
Phase 3 | - | qrwwrtnzte(mvcetejhby) = ukqpisnkct qtammcgofd (cquhmzhbek, 11.48 - 11.85) View more | Positive | 07 Jun 2020 | |||
uvqdqudrka(gzaovihsdw) = cdykjczuzt zkjeobxgvp (wmlxhocmpy, 12.33) | |||||||
Phase 2 | 101 | gafvicfjhq(amhnwqjftb) = an increase in TIBC values were observed in the molidustat group vhgkvhctgb (gnxnpldtoj ) View more | Positive | 18 May 2018 | |||
Placebo | |||||||
Not Applicable | - | ghlqmgovvj(dmohaidquj) = Treatment emergent adverse events (TEAE) were reported in 69.6% of molidustat treated subjects and in 53.1% of subjects on darbepoetin aqlhflylef (djqoxrypnt ) View more | - | 14 May 2016 | |||
Phase 2 | 121 | wnnwxdpaty(jomrvqwite) = Treatment emergent adverse events (TEAE) were reported in 66.3% of all molidustat treated subjects and in 80% of subjects on placebo zfzowwkyhy (wzvxnypokl ) View more | Positive | 14 May 2016 | |||





