Last reviewed 2026-06-02 · How we verify

Mitiglinide calcium hydrate

Astellas Pharma Inc · Phase 1 active Small molecule ✓ Verified Jun 2026

Mitiglinide calcium hydrate is a Small molecule drug developed by Astellas Pharma Inc. It is currently in Phase 1 development. Also known as: Glufast.

Mitiglinide calcium hydrate is a medication used to study its pharmacokinetics and potential interactions with other drugs, such as ASP1941 and Alogliptin, in clinical trials. It is also used to treat diabetes mellitus, as indicated by ClinicalTrials.gov.

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	Mitiglinide calcium hydrate
Also known as	Glufast
Sponsor	Astellas Pharma Inc
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

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:

Mitiglinide calcium hydrate CI brief — competitive landscape report
Mitiglinide calcium hydrate updates RSS · CI watch RSS
Astellas Pharma Inc portfolio CI

Frequently asked questions about Mitiglinide calcium hydrate

What is Mitiglinide calcium hydrate?

Mitiglinide calcium hydrate is a Small molecule drug developed by Astellas Pharma Inc.

Who makes Mitiglinide calcium hydrate?

Mitiglinide calcium hydrate is developed by Astellas Pharma Inc (see full Astellas Pharma Inc pipeline at /company/astellas).

Is Mitiglinide calcium hydrate also known as anything else?

Mitiglinide calcium hydrate is also known as Glufast.

What development phase is Mitiglinide calcium hydrate in?

Mitiglinide calcium hydrate is in Phase 1.

Manufacturer: Astellas Pharma Inc — full pipeline
Also known as: Glufast

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