Last reviewed 2026-06-02 · How we verify

Sildenafill-Test product

Bio-innova Co., Ltd · Phase 1 active Small molecule ✓ Verified Jun 2026

Sildenafill-Test product is a Small molecule drug developed by Bio-innova Co., Ltd. It is currently in Phase 1 development.

Sildenafil-Test is a small molecule product that has been studied in a bioequivalence trial to compare its effects to a reference product, Viagra 100 mg Tablets, in healthy male volunteers. The study, NCT06289881, was conducted under fasting conditions to assess the relative bioavailability of Sildenafil-Test compared to Viagra 100 mg Tablets.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Sildenafill-Test product
Sponsor	Bio-innova Co., Ltd
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Sildenafil 100 mg Tablets Relative to Viagra 100 mg Tablets (PHASE1)

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:

Sildenafill-Test product CI brief — competitive landscape report
Sildenafill-Test product updates RSS · CI watch RSS
Bio-innova Co., Ltd portfolio CI

Frequently asked questions about Sildenafill-Test product

What is Sildenafill-Test product?

Sildenafill-Test product is a Small molecule drug developed by Bio-innova Co., Ltd.

Who makes Sildenafill-Test product?

Sildenafill-Test product is developed by Bio-innova Co., Ltd (see full Bio-innova Co., Ltd pipeline at /company/bio-innova-co-ltd).

What development phase is Sildenafill-Test product in?

Sildenafill-Test product is in Phase 1.

Manufacturer: Bio-innova Co., Ltd — full pipeline

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