RyR1 Structural Alterations Explain Statin-Associated Muscle Dysfunction
December 16, 2025
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Brand Name :
Modeyso
Synonyms :
Dordaviprone
Class :
AKT Inhibitors
Brand Name :
Modeyso
Synonyms :
Dordaviprone
Class :
AKT Inhibitors
ADULT DOSING
Dosage Forms & Strengths
Capsule
125 mg
Glioma
Take dose of 625 mg orally for one time every week
PEDIATRIC DOSING
Dosage Forms & Strengths
Capsule
125 mg
GERIATRIC DOSING
Refer to adult dosing
The mitochondrial caseinolytic protease P (ClpP) is activated by the protease dordaviprone. It also inhibits the D2 receptor for dopamine.
The reduction of H3 K27 trimethylation is linked to diffuse midline gliomas with an H3 K27M mutation.
In H3 K27M-mutant diffuse glioma models, dordaviprone restored histone H3 K27 trimethylation by inducing apoptosis, activating the integrated stress response, changing mitochondrial metabolism.
Frequency not defined
Headache
Dysarthria
Dizziness
Vomiting
Musculoskeletal pain
Muscular weakness
Cranial nerve disorder
Hemiparesis
Nausea
Dysphagia
Constipation
Rash
Hyperglycemia
Black Box Warning
None
Contraindication/Caution:
Contraindication:
None
Caution:
QTc Interval Prolongation
Hypersensitivity
Embryo-fetal Toxicity
Pregnancy Warnings:
Pregnancy category: N/A
Lactation: Excretion in human breastmilk is unknown
Pregnancy categories:
Category A: Satisfactory and well-controlled studies show no evidence of risk to the fetus in the first trimester or in the later trimester.
Category B: No evidence of risk to fetus found in animal reproduction studies and there are not enough studies on pregnant women.
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women.
Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits.
Category X: Drugs listed in this category clearly outweigh risks over benefits. These category drugs should be prohibited for pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology:
Dordaviprone’s nonclinical safety record is indicative of its dopamine receptor inhibition and on-target pharmacology.
Dordaviprone shows anticancer efficacy in both in vivo models of H3 K27M-mutant diffuse glioma and cell-based tests.
Dordaviprone administered orally once a week to dogs resulted in toxicities linked to the central nervous system in repeat-dose toxicology tests conducted for up to 13 weeks.
Pharmacodynamics:
For the safety and efficacy of dordaviprone, the exposure-response relationship and the pharmacodynamic response time course have not been well described.
Pharmacokinetics:
Absorption:
It has median time to reach maximum plasma concentration is 1.4 hours.
Distribution
It shows volume of distribution up to 450 L.
It shows plasma protein binding of 95% to 97%.
Metabolism
It is metabolized through CYP3A4 pathways.
Elimination and excretion
It is eliminated through urine. It has half-life of 11 hours.
Administration:
It is recommended that patient should take MODEYSO oral capsule once a week without eating anything for at least one hour before or three hours after taking it.
Patient should take the recommended dosage on the same day of the week at the same time.
The capsule should be swallowed whole.
Patients who cannot swallow whole capsule should be instructed to open them and combine the contents with 15 to 30 ml of liquid.
After consuming the combination, advise patients to fill the container with an additional 15 to 30 ml of liquid and spin to dissolve any leftover medicine, and then again consume the remaining contents.
Patient information leaflet
Generic Name: dordaviprone
Pronounced: door-da-vi-pro-en
Why do we use dordaviprone?
Dordaviprone (MODEYSO) is recommended for the treatment of diffuse midline gliomas with an H3 K27M mutation in adults.
It is also used in children aged 1 year and up whose illness has progressed after previous treatment.
The overall response rate and response duration determine whether this indication is granted under facilitated approval.
The confirmation of clinical benefit in a confirmatory study may be necessary for this indication’s continued approval.
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