Last reviewed 2026-04-23 · How we verify

KDF1901-R0

Kyungdong Pharmaceutical Co., Ltd. · Phase 3 active Small molecule

KDF1901-R0 is a SGLT2 inhibitor Small molecule drug developed by Kyungdong Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Type 2 diabetes.

KDF1901-R0 is a small molecule that targets the SGLT2 receptor.

KDF1901-R0 is a small molecule that targets the SGLT2 receptor. Used for Type 2 diabetes.

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	KDF1901-R0
Sponsor	Kyungdong Pharmaceutical Co., Ltd.
Drug class	SGLT2 inhibitor
Target	SGLT2
Modality	Small molecule
Therapeutic area	Diabetes
Phase	Phase 3

Mechanism of action

By inhibiting SGLT2, KDF1901-R0 reduces glucose reabsorption in the kidneys, thereby lowering blood glucose levels. This makes it a potential treatment for type 2 diabetes.

Approved indications

Type 2 diabetes

Common side effects

Nausea
Diarrhea
Vomiting

Key clinical trials

A Multicenter, Randomized, Double-Blind Phase 3 Trial of KDF1901 in Patients With Essential Hypertension (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:

KDF1901-R0 CI brief — competitive landscape report
KDF1901-R0 updates RSS · CI watch RSS
Kyungdong Pharmaceutical Co., Ltd. portfolio CI

Frequently asked questions about KDF1901-R0

What is KDF1901-R0?

KDF1901-R0 is a SGLT2 inhibitor drug developed by Kyungdong Pharmaceutical Co., Ltd., indicated for Type 2 diabetes.

How does KDF1901-R0 work?

KDF1901-R0 is a small molecule that targets the SGLT2 receptor.

What is KDF1901-R0 used for?

KDF1901-R0 is indicated for Type 2 diabetes.

Who makes KDF1901-R0?

KDF1901-R0 is developed by Kyungdong Pharmaceutical Co., Ltd. (see full Kyungdong Pharmaceutical Co., Ltd. pipeline at /company/kyungdong-pharmaceutical-co-ltd).

What drug class is KDF1901-R0 in?

KDF1901-R0 belongs to the SGLT2 inhibitor class. See all SGLT2 inhibitor drugs at /class/sglt2-inhibitor.

What development phase is KDF1901-R0 in?

KDF1901-R0 is in Phase 3.

What are the side effects of KDF1901-R0?

Common side effects of KDF1901-R0 include Nausea, Diarrhea, Vomiting.

What does KDF1901-R0 target?

KDF1901-R0 targets SGLT2 and is a SGLT2 inhibitor.

Drug class: All SGLT2 inhibitor drugs
Target: All drugs targeting SGLT2
Manufacturer: Kyungdong Pharmaceutical Co., Ltd. — full pipeline
Therapeutic area: All drugs in Diabetes
Indication: Drugs for Type 2 diabetes

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