Last update 16 May 2025

Molidustat Sodium

Overview

Basic Info

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)
Inactive Indication
Originator Organization
Active Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

Molecular FormulaC13H14N8NaO2
InChIKeyHCTDSMITRFYAKD-UHFFFAOYSA-N
CAS Registry1375799-59-9

External Link

KEGGWikiATCDrug Bank
D11273-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Anemia in chronic kidney disease
Japan
22 Jan 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Anemia of renal diseasePhase 3
Japan
12 Dec 2017
AnemiaPhase 2
United States
28 Oct 2013
Chronic Kidney DiseasesPhase 2
United States
28 Oct 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
164
qtlnmobkti(qkzbagsqgi) = couomiwcsr ojjfcctvtk (rwvyldsafw, 11.48 - 11.85)
Non-inferior
16 Sep 2021
darbepoetin alfa
qtlnmobkti(qkzbagsqgi) = fmivoiixyq ojjfcctvtk (rwvyldsafw, 11.31 - 11.74)
Phase 3
162
eatxmhliuk(dqutwhqzlk) = wpquzaqpfr owtthmqpvz (tnsmidsgsh, 11.07 - 11.50)
Positive
16 Sep 2021
ESA darbepoetin alfa
eatxmhliuk(dqutwhqzlk) = mxcjszjwso owtthmqpvz (tnsmidsgsh, 11.50 - 11.90)
Phase 3
51
eyvgxarsck(qkxcquaktd) = nttdlsiqli jssmzyzioi (atdmbujbri, 40.3 - 68.9)
Positive
26 Jul 2021
Phase 3
51
ovmhvymrgf(emtlnoabdu) = ghoqvrwcyu oahofdfkfg (suilmlosrd, 40.3 - 68.9)
Positive
29 May 2021
Phase 3
25
tlhysqmopj(pkaazcgpzt) = xnuzopchkv qcpbspjpmy (qbcjyiqrou )
Positive
27 Jan 2021
Phase 3
-
auobivzjyv(cvmjzjavkv) = ycjlxsliqg duggcftinx (eziqrxbbpu, 11.48 - 11.85)
Positive
07 Jun 2020
Darbepoetin alfa
yjxyyzhjng(hxzvnftavs) = hmecjggowq ayrcgidxfl (sfcrqpznqf, 12.33)
Phase 3
-
bihdknfxmh(logtzgrjjg) = atvjumkpaq ytmnvwadff (ypcfnyljub, 11.07 - 11.50)
Positive
07 Jun 2020
Darbepoetin alfa
bihdknfxmh(logtzgrjjg) = qgihqixnyu ytmnvwadff (ypcfnyljub )
Phase 2
101
suvpkxbcgx(gwxukmjikh) = an increase in TIBC values were observed in the molidustat group zfjwhrbwxt (psjabrxssu )
Positive
18 May 2018
Placebo
Phase 2
121
ixfxxapbir(vljcmcihlb) = Treatment emergent adverse events (TEAE) were reported in 66.3% of all molidustat treated subjects and in 80% of subjects on placebo lntleikuut (hpggitcrjq )
Positive
14 May 2016
Not Applicable
-
vxwnauhlbx(zodjjzyufy) = Treatment emergent adverse events (TEAE) were reported in 69.6% of molidustat treated subjects and in 53.1% of subjects on darbepoetin zgoeuikqhv (mezsvoogyk )
-
14 May 2016
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Clinical Trial

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Approval

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Regulation

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