pr Sandoz Tamsulosin

CHU de Quebec-Universite Laval · Phase 3 active Small molecule

pr Sandoz Tamsulosin is a Alpha-1 adrenergic receptor antagonist Small molecule drug developed by CHU de Quebec-Universite Laval. It is currently in Phase 3 development for Benign prostatic hyperplasia (BPH) symptoms, Lower urinary tract symptoms (LUTS). Also known as: Tamsulosin hydrochloride.

Tamsulosin is an alpha-1 adrenergic receptor antagonist that relaxes smooth muscles in the prostate and bladder neck, improving urine flow.

Tamsulosin is an alpha-1 adrenergic receptor antagonist that relaxes smooth muscles in the prostate and bladder neck, improving urine flow. Used for Benign prostatic hyperplasia (BPH) symptoms, Lower urinary tract symptoms (LUTS).

Likelihood of approval

58.3% 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).

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 name	pr Sandoz Tamsulosin
Also known as	Tamsulosin hydrochloride
Sponsor	CHU de Quebec-Universite Laval
Drug class	Alpha-1 adrenergic receptor antagonist
Target	Alpha-1 adrenergic receptor
Modality	Small molecule
Therapeutic area	Urology
Phase	Phase 3

Mechanism of action

By blocking alpha-1 adrenergic receptors, tamsulosin reduces the muscle tone in the prostate and bladder neck, making it easier to urinate. This is particularly beneficial for men with benign prostatic hyperplasia (BPH).

Approved indications

• Benign prostatic hyperplasia (BPH) symptoms
• Lower urinary tract symptoms (LUTS)

Common side effects

• Dizziness
• Headache
• Nausea
• Diarrhea
• Fatigue

Key clinical trials

• Prophylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection (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:

• pr Sandoz Tamsulosin CI brief — competitive landscape report
• pr Sandoz Tamsulosin updates RSS · CI watch RSS
• CHU de Quebec-Universite Laval portfolio CI

Frequently asked questions about pr Sandoz Tamsulosin

What is pr Sandoz Tamsulosin?

pr Sandoz Tamsulosin is a Alpha-1 adrenergic receptor antagonist drug developed by CHU de Quebec-Universite Laval, indicated for Benign prostatic hyperplasia (BPH) symptoms, Lower urinary tract symptoms (LUTS).

How does pr Sandoz Tamsulosin work?

Tamsulosin is an alpha-1 adrenergic receptor antagonist that relaxes smooth muscles in the prostate and bladder neck, improving urine flow.

What is pr Sandoz Tamsulosin used for?

pr Sandoz Tamsulosin is indicated for Benign prostatic hyperplasia (BPH) symptoms, Lower urinary tract symptoms (LUTS).

Who makes pr Sandoz Tamsulosin?

pr Sandoz Tamsulosin is developed by CHU de Quebec-Universite Laval (see full CHU de Quebec-Universite Laval pipeline at /company/chu-de-quebec-universite-laval).

Is pr Sandoz Tamsulosin also known as anything else?

pr Sandoz Tamsulosin is also known as Tamsulosin hydrochloride.

What drug class is pr Sandoz Tamsulosin in?

pr Sandoz Tamsulosin belongs to the Alpha-1 adrenergic receptor antagonist class. See all Alpha-1 adrenergic receptor antagonist drugs at /class/alpha-1-adrenergic-receptor-antagonist.

What development phase is pr Sandoz Tamsulosin in?

pr Sandoz Tamsulosin is in Phase 3.

What are the side effects of pr Sandoz Tamsulosin?

Common side effects of pr Sandoz Tamsulosin include Dizziness, Headache, Nausea, Diarrhea, Fatigue.

What does pr Sandoz Tamsulosin target?

pr Sandoz Tamsulosin targets Alpha-1 adrenergic receptor and is a Alpha-1 adrenergic receptor antagonist.

Related

• Drug class: All Alpha-1 adrenergic receptor antagonist drugs
• Target: All drugs targeting Alpha-1 adrenergic receptor
• Manufacturer: CHU de Quebec-Universite Laval — full pipeline
• Therapeutic area: All drugs in Urology
• Indication: Drugs for Benign prostatic hyperplasia (BPH) symptoms
• Indication: Drugs for Lower urinary tract symptoms (LUTS)
• Also known as: Tamsulosin hydrochloride