Last reviewed 2026-05-28 · How we verify

BONT-A intra-prostatic injection

University Hospital, Bordeaux · Phase 3 active Small molecule ✓ Verified May 2026

BONT-A intra-prostatic injection is a Botulinum toxin Small molecule drug developed by University Hospital, Bordeaux. It is currently in Phase 3 development for Lower urinary tract symptoms secondary to benign prostatic hyperplasia, Overactive bladder symptoms.

Botulinum toxin type A injected directly into the prostate blocks acetylcholine release at nerve endings to reduce smooth muscle contractions and lower urinary symptoms.

BONT-A intra-prostatic injection is being studied as a treatment for Prostatic Hyperplasia. It is being investigated as part of an optimized medical treatment for Benign Prostatic Hyperplasia (BPH) through a clinical trial.

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	BONT-A intra-prostatic injection
Sponsor	University Hospital, Bordeaux
Drug class	Botulinum toxin
Target	SNARE complex (acetylcholine release machinery)
Modality	Small molecule
Therapeutic area	Urology
Phase	Phase 3

Mechanism of action

BONT-A (botulinum neurotoxin type A) inhibits acetylcholine release by cleaving SNARE proteins at the neuromuscular junction. When injected intra-prostatically, it reduces detrusor and prostatic smooth muscle contractions, decreasing urinary frequency, urgency, and improving flow in benign prostatic hyperplasia and lower urinary tract symptoms.

Approved indications

Lower urinary tract symptoms secondary to benign prostatic hyperplasia
Overactive bladder symptoms

Common side effects

Urinary tract infection
Urinary retention
Hematuria
Dysuria

Key clinical trials

A-botulinic Toxin for Symptomatic Benign Prostate Hypertrophy (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:

BONT-A intra-prostatic injection CI brief — competitive landscape report
BONT-A intra-prostatic injection updates RSS · CI watch RSS
University Hospital, Bordeaux portfolio CI

Frequently asked questions about BONT-A intra-prostatic injection

What is BONT-A intra-prostatic injection?

BONT-A intra-prostatic injection is a Botulinum toxin drug developed by University Hospital, Bordeaux, indicated for Lower urinary tract symptoms secondary to benign prostatic hyperplasia, Overactive bladder symptoms.

How does BONT-A intra-prostatic injection work?

Botulinum toxin type A injected directly into the prostate blocks acetylcholine release at nerve endings to reduce smooth muscle contractions and lower urinary symptoms.

What is BONT-A intra-prostatic injection used for?

BONT-A intra-prostatic injection is indicated for Lower urinary tract symptoms secondary to benign prostatic hyperplasia, Overactive bladder symptoms.

Who makes BONT-A intra-prostatic injection?

BONT-A intra-prostatic injection is developed by University Hospital, Bordeaux (see full University Hospital, Bordeaux pipeline at /company/university-hospital-bordeaux).

What drug class is BONT-A intra-prostatic injection in?

BONT-A intra-prostatic injection belongs to the Botulinum toxin class. See all Botulinum toxin drugs at /class/botulinum-toxin.

What development phase is BONT-A intra-prostatic injection in?

BONT-A intra-prostatic injection is in Phase 3.

What are the side effects of BONT-A intra-prostatic injection?

Common side effects of BONT-A intra-prostatic injection include Urinary tract infection, Urinary retention, Hematuria, Dysuria.

What does BONT-A intra-prostatic injection target?

BONT-A intra-prostatic injection targets SNARE complex (acetylcholine release machinery) and is a Botulinum toxin.

Drug class: All Botulinum toxin drugs
Target: All drugs targeting SNARE complex (acetylcholine release machinery)
Manufacturer: University Hospital, Bordeaux — full pipeline
Therapeutic area: All drugs in Urology
Indication: Drugs for Lower urinary tract symptoms secondary to benign prostatic hyperplasia
Indication: Drugs for Overactive bladder symptoms

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