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SoluMatrix™ Abiraterone Acetate
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.
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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.
| 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 name | SoluMatrix™ Abiraterone Acetate |
|---|---|
| Also known as | Yonza, SoluMatrix™ |
| Sponsor | GU Research Network, LLC |
| Drug class | CYP17 inhibitor |
| Target | CYP17 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 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
- Metastatic castration-resistant prostate cancer
- Non-metastatic castration-resistant prostate cancer
Common side effects
- Adrenal insufficiency
- Hypertension
- Fatigue
- Diarrhea
- Nausea
Key clinical trials
- A Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer (PHASE2)
- Extension of SoluMatrix TM Abiraterone Acetate in Patients Who Completed Study Number CHL-AA-201 (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial 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:
- SoluMatrix™ Abiraterone Acetate CI brief — competitive landscape report
- SoluMatrix™ Abiraterone Acetate updates RSS · CI watch RSS
- GU Research Network, LLC portfolio CI
Frequently asked questions about SoluMatrix™ Abiraterone Acetate
What is SoluMatrix™ Abiraterone Acetate?
How does SoluMatrix™ Abiraterone Acetate work?
What is SoluMatrix™ Abiraterone Acetate used for?
Who makes SoluMatrix™ Abiraterone Acetate?
Is SoluMatrix™ Abiraterone Acetate also known as anything else?
What drug class is SoluMatrix™ Abiraterone Acetate in?
What development phase is SoluMatrix™ Abiraterone Acetate in?
What are the side effects of SoluMatrix™ Abiraterone Acetate?
What does SoluMatrix™ Abiraterone Acetate target?
Related
- Drug class: All CYP17 inhibitor drugs
- Target: All drugs targeting CYP17
- Manufacturer: GU Research Network, LLC — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic castration-resistant prostate cancer
- Indication: Drugs for Non-metastatic castration-resistant prostate cancer
- Also known as: Yonza, SoluMatrix™
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing