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Tamsulosin formulation-A
Tamsulosin formulation-A is a Small molecule drug developed by Astellas Pharma China, Inc.. It is currently in Phase 1 development. Also known as: Harnal.
Tamsulosin formulation-A is used to treat conditions such as Prostatic Hyperplasia and Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH). It works as an adrenergic receptor alpha-1 antagonist, a small molecule that blocks the action of alpha-1 receptors.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Tamsulosin formulation-A |
|---|---|
| Also known as | Harnal |
| Sponsor | Astellas Pharma China, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A PK Study GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers (PHASE1)
- Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects (PHASE1)
- Bioavailability of Two Combination Products of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) in Asian Males. (PHASE1)
- A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia (PHASE1)
- A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State (PHASE1)
- Bioequivalence - Duodart Against Avodart & Omnic (PHASE1)
- A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry. (PHASE1)
- A Study to Evaluate the Tolerability and Efficacy of Tamsulosin 0.4mg OCAS Formulation in Patients Who Are Unsatisfied With the Treatment of Tamsulosin 0.2mg Conventional Formulation (PHASE4)
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:
- Tamsulosin formulation-A CI brief — competitive landscape report
- Tamsulosin formulation-A updates RSS · CI watch RSS
- Astellas Pharma China, Inc. portfolio CI
Frequently asked questions about Tamsulosin formulation-A
What is Tamsulosin formulation-A?
Who makes Tamsulosin formulation-A?
Is Tamsulosin formulation-A also known as anything else?
What development phase is Tamsulosin formulation-A in?
Related
- Manufacturer: Astellas Pharma China, Inc. — full pipeline
- Also known as: Harnal
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing