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Abiraterone Acetate (ABIRATERONE)

Janssen Biotech · FDA-approved active Small molecule Quality 42/100

Abiraterone Acetate blocks the production of androgens, which are hormones that prostate cancer cells need to grow.

Abiraterone Acetate is a small molecule medication originally developed by Dr Reddys and currently owned by Janssen Biotech. It is approved by the FDA for the treatment of metastatic castration-resistant prostate cancer (CRPC) and metastatic high-risk castration-sensitive prostate cancer (CSPC. The medication is off-patent, with 13 generic manufacturers available. Abiraterone Acetate works by inhibiting the production of androgens, which are hormones that fuel the growth of prostate cancer cells. It is a commercially available treatment option for patients with these conditions.

At a glance

Generic nameABIRATERONE
SponsorJanssen Biotech
ModalitySmall molecule
Therapeutic areaOncology
PhaseFDA-approved
First approval2021

Mechanism of action

Abiraterone acetate is converted in vivo to abiraterone, an androgen biosynthesis inhibitor, that inhibits 17 α-hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in testicular, adrenal, and prostatic tumor tissues and is required for androgen biosynthesis. CYP17 catalyzes two sequential reactions: 1) the conversion of pregnenolone and progesterone to their 17α-hydroxy derivatives by 17α-hydroxylase activity and 2) the subsequent formation of dehydroepiandrosterone (DHEA) and androstenedione, respectively, by C17, 20 lyase activity. DHEA and androstenedione are androgens and are precursors of testosterone. Inhibition of CYP17 by abiraterone can also result in increased mineralocorticoid production by the adrenals [see Warnings and Precautions ( 5.1 )]. Androgen sensitive prostatic carcinoma responds to treatment that decreases androgen levels. Androgen deprivation therapies, such as treatment with GnRH agonists or orchiectomy, decrease androgen producti

Approved indications

Common side effects

Drug interactions

Key clinical trials

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results

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