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SoluMatrix™ Abiraterone Acetate

GU Research Network, LLC · Phase 3 active Small molecule Under review

SoluMatrix™ Abiraterone Acetate is a CYP17 inhibitor Small molecule drug developed by GU Research Network, LLC. It is currently in Phase 3 development for Metastatic castration-resistant prostate cancer, Non-metastatic castration-resistant prostate cancer. Also known as: Yonza, SoluMatrix™.

Abiraterone acetate is a CYP17 inhibitor that blocks the production of androgens, such as testosterone, in the body.

SoluMatrix Abiraterone Acetate is a small molecule inhibitor of the cytochrome P450 17A1 enzyme, specifically targeting steroid 17-alpha-hydroxylase/17,20 lyase. It is used to treat prostate cancer, as indicated by clinical trials registered on ClinicalTrials.gov.

Likelihood of approval
61.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Oncology Phase 3 boost +3.0pp
    Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2028–2030
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic nameSoluMatrix™ Abiraterone Acetate
Also known asYonza, SoluMatrix™
SponsorGU Research Network, LLC
Drug classCYP17 inhibitor
TargetCYP17
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 3

Mechanism of action

By inhibiting CYP17, abiraterone acetate reduces the levels of androgens, which can slow the growth of prostate cancer cells. This mechanism is particularly effective in treating castration-resistant prostate cancer.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about SoluMatrix™ Abiraterone Acetate

What is SoluMatrix™ Abiraterone Acetate?

SoluMatrix™ Abiraterone Acetate is a CYP17 inhibitor drug developed by GU Research Network, LLC, indicated for Metastatic castration-resistant prostate cancer, Non-metastatic castration-resistant prostate cancer.

How does SoluMatrix™ Abiraterone Acetate work?

Abiraterone acetate is a CYP17 inhibitor that blocks the production of androgens, such as testosterone, in the body.

What is SoluMatrix™ Abiraterone Acetate used for?

SoluMatrix™ Abiraterone Acetate is indicated for Metastatic castration-resistant prostate cancer, Non-metastatic castration-resistant prostate cancer.

Who makes SoluMatrix™ Abiraterone Acetate?

SoluMatrix™ Abiraterone Acetate is developed by GU Research Network, LLC (see full GU Research Network, LLC pipeline at /company/gu-research-network-llc).

Is SoluMatrix™ Abiraterone Acetate also known as anything else?

SoluMatrix™ Abiraterone Acetate is also known as Yonza, SoluMatrix™.

What drug class is SoluMatrix™ Abiraterone Acetate in?

SoluMatrix™ Abiraterone Acetate belongs to the CYP17 inhibitor class. See all CYP17 inhibitor drugs at /class/cyp17-inhibitor.

What development phase is SoluMatrix™ Abiraterone Acetate in?

SoluMatrix™ Abiraterone Acetate is in Phase 3.

What are the side effects of SoluMatrix™ Abiraterone Acetate?

Common side effects of SoluMatrix™ Abiraterone Acetate include Adrenal insufficiency, Hypertension, Fatigue, Diarrhea, Nausea.

What does SoluMatrix™ Abiraterone Acetate target?

SoluMatrix™ Abiraterone Acetate targets CYP17 and is a CYP17 inhibitor.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing