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Silodosin capsules Control Group
Silodosin capsules Control Group is a Alpha-1 adrenergic receptor antagonist Small molecule drug developed by Shanghai Huilun Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Benign prostatic hyperplasia (BPH).
Silodosin is an alpha-1 adrenergic receptor antagonist.
Silodosin capsules are used as a control group in a clinical study for the treatment of Benign Prostatic Hyperplasia. The study compares Silodosin capsules to H077 sustained-release tablets in the treatment of Benign Prostatic Hyperplasia.
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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).
| 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 | Silodosin capsules Control Group |
|---|---|
| Sponsor | Shanghai Huilun Pharmaceutical Co., Ltd. |
| Drug class | Alpha-1 adrenergic receptor antagonist |
| Target | Alpha-1 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Urology |
| Phase | Phase 3 |
Mechanism of action
Silodosin works by blocking alpha-1 adrenergic receptors in the smooth muscle of the prostate and bladder neck, leading to relaxation of these muscles and a decrease in the symptoms of benign prostatic hyperplasia (BPH). This results in improved urine flow and reduced symptoms of BPH.
Approved indications
- Benign prostatic hyperplasia (BPH)
Common side effects
- Dizziness
- Headache
- Nausea
- Fatigue
- Orthostatic hypotension
Key clinical trials
- A Phase III Clinical Study of H077 Sustained-Release Tablets Compared With Silodosin Capsules in the Treatment of Benign Prostatic Hyperplasia (PHASE3)
- Silodosin in Facilitating Flexible Uretroscopy (NA)
- Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome. (PHASE2)
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:
- Silodosin capsules Control Group CI brief — competitive landscape report
- Silodosin capsules Control Group updates RSS · CI watch RSS
- Shanghai Huilun Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Silodosin capsules Control Group
What is Silodosin capsules Control Group?
How does Silodosin capsules Control Group work?
What is Silodosin capsules Control Group used for?
Who makes Silodosin capsules Control Group?
What drug class is Silodosin capsules Control Group in?
What development phase is Silodosin capsules Control Group in?
What are the side effects of Silodosin capsules Control Group?
What does Silodosin capsules Control Group target?
Related
- Drug class: All Alpha-1 adrenergic receptor antagonist drugs
- Target: All drugs targeting Alpha-1 adrenergic receptor
- Manufacturer: Shanghai Huilun Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Urology
- Indication: Drugs for Benign prostatic hyperplasia (BPH)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing