Last reviewed 2026-05-18 · How we verify

Dapagliflozin-Reference product

Bio-innova Co., Ltd · Phase 1 active Small molecule Quality 60/100

Dapagliflozin-Reference product is a SGLT2 inhibitor Small molecule drug developed by Bio-innova Co., Ltd. It is currently in Phase 1 development.

Inhibits sodium-glucose co-transporter 2 (SGLT2) in the kidney, reducing glucose reabsorption and increasing urinary glucose excretion.

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	Dapagliflozin-Reference product
Sponsor	Bio-innova Co., Ltd
Drug class	SGLT2 inhibitor
Modality	Small molecule
Phase	Phase 1

Mechanism of action

Dapagliflozin selectively inhibits SGLT2 in the proximal renal tubule, blocking reabsorption of filtered glucose and lowering blood glucose levels independent of insulin. This mechanism also reduces sodium reabsorption, leading to osmotic diuresis and beneficial cardiovascular and renal effects.

Approved indications

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

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

Frequently asked questions about Dapagliflozin-Reference product

What is Dapagliflozin-Reference product?

Dapagliflozin-Reference product is a SGLT2 inhibitor drug developed by Bio-innova Co., Ltd.

How does Dapagliflozin-Reference product work?

Inhibits sodium-glucose co-transporter 2 (SGLT2) in the kidney, reducing glucose reabsorption and increasing urinary glucose excretion.

Who makes Dapagliflozin-Reference product?

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

What drug class is Dapagliflozin-Reference product in?

Dapagliflozin-Reference product belongs to the SGLT2 inhibitor class. See all SGLT2 inhibitor drugs at /class/sglt2-inhibitor.

What development phase is Dapagliflozin-Reference product in?

Dapagliflozin-Reference product is in Phase 1.

Drug class: All SGLT2 inhibitor drugs
Manufacturer: Bio-innova Co., Ltd — full pipeline

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