Last reviewed 2026-04-23 · How we verify

Glipizide GITS

Pfizer · Phase 2 active Small molecule

Glipizide GITS is a Sulfonylurea Small molecule drug developed by Pfizer. It is currently in Phase 2 development for Type 2 diabetes.

Sulfonylurea receptor agonist

Sulfonylurea receptor agonist Used for Type 2 diabetes.

Likelihood of approval

18.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Big-pharma sponsor +3.0pp
Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Glipizide GITS
Sponsor	Pfizer
Drug class	Sulfonylurea
Target	SUR1
Modality	Small molecule
Therapeutic area	Diabetes
Phase	Phase 2

Mechanism of action

Glipizide acts as a sulfonylurea receptor agonist, stimulating insulin release from pancreatic beta cells.

Approved indications

Type 2 diabetes

Common side effects

Hypoglycemia
Nausea
Diarrhea

Key clinical trials

Bioequivalence Study Of Glucotrol XL 2.5 Mg Tablets

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:

Glipizide GITS CI brief — competitive landscape report
Glipizide GITS updates RSS · CI watch RSS
Pfizer portfolio CI

Frequently asked questions about Glipizide GITS

What is Glipizide GITS?

Glipizide GITS is a Sulfonylurea drug developed by Pfizer, indicated for Type 2 diabetes.

How does Glipizide GITS work?

Sulfonylurea receptor agonist

What is Glipizide GITS used for?

Glipizide GITS is indicated for Type 2 diabetes.

Who makes Glipizide GITS?

Glipizide GITS is developed by Pfizer (see full Pfizer pipeline at /company/pfizer).

What drug class is Glipizide GITS in?

Glipizide GITS belongs to the Sulfonylurea class. See all Sulfonylurea drugs at /class/sulfonylurea.

What development phase is Glipizide GITS in?

Glipizide GITS is in Phase 2.

What are the side effects of Glipizide GITS?

Common side effects of Glipizide GITS include Hypoglycemia, Nausea, Diarrhea.

What does Glipizide GITS target?

Glipizide GITS targets SUR1 and is a Sulfonylurea.

Drug class: All Sulfonylurea drugs
Target: All drugs targeting SUR1
Manufacturer: Pfizer — 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