Last reviewed 2026-06-01 · How we verify

AJU-A51 Tab.

AJU Pharm Co., Ltd. · Phase 1 active Small molecule ✓ Verified Jun 2026 Quality 0/100

AJU-A51 Tab. is a Small molecule drug developed by AJU Pharm Co., Ltd.. It is currently in Phase 1 development. Also known as: Test drug.

AJU-A51 Tab is a medication being studied for the treatment of Type 2 Diabetes Mellitus. A randomized clinical trial (NCT04972539) is evaluating the pharmacokinetics and safety of AJU-A51 Tab in healthy adults.

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	AJU-A51 Tab.
Also known as	Test drug
Sponsor	AJU Pharm 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

Evaluation of Pharmacokinetics and Safety of AJU-A51 in Healthy Adults (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:

AJU-A51 Tab. CI brief — competitive landscape report
AJU-A51 Tab. updates RSS · CI watch RSS
AJU Pharm Co., Ltd. portfolio CI

Frequently asked questions about AJU-A51 Tab.

What is AJU-A51 Tab.?

AJU-A51 Tab. is a Small molecule drug developed by AJU Pharm Co., Ltd..

Who makes AJU-A51 Tab.?

AJU-A51 Tab. is developed by AJU Pharm Co., Ltd. (see full AJU Pharm Co., Ltd. pipeline at /company/aju-pharm-co-ltd).

Is AJU-A51 Tab. also known as anything else?

AJU-A51 Tab. is also known as Test drug.

What development phase is AJU-A51 Tab. in?

AJU-A51 Tab. is in Phase 1.

Manufacturer: AJU Pharm Co., Ltd. — full pipeline
Also known as: Test drug

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