Last reviewed 2026-05-31 · How we verify

Sintisone (PREDNISOLONE STEAGLATE)

Phase 2 active Small molecule ✓ Verified May 2026

Sintisone (generic name: PREDNISOLONE STEAGLATE) is a Corticosteroid drug. It is currently in Phase 2 development.

Sintisone works by suppressing the immune system's inflammatory response to reduce swelling and pain.

Sintisone is a small molecule medication. It is also known by other names, including Prednisolone 21-stearoylglycolate, Prednisolone Steaglate, and Prednisolone 21-stearoylglycolate.

Likelihood of approval

16.3% 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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

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	PREDNISOLONE STEAGLATE
Drug class	Corticosteroid
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 2

Mechanism of action

Imagine your immune system is like a fire that gets out of control when it's fighting an infection. Sintisone helps put out the fire by reducing the production of chemicals that cause inflammation, which in turn reduces swelling and pain.

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:

Sintisone CI brief — competitive landscape report
Sintisone updates RSS · CI watch RSS

Frequently asked questions about Sintisone

What is Sintisone?

Sintisone (PREDNISOLONE STEAGLATE) is a Corticosteroid drug.

How does Sintisone work?

Sintisone works by suppressing the immune system's inflammatory response to reduce swelling and pain.

What is the generic name of Sintisone?

PREDNISOLONE STEAGLATE is the generic (nonproprietary) name of Sintisone.

What drug class is Sintisone in?

Sintisone belongs to the Corticosteroid class. See all Corticosteroid drugs at /class/corticosteroid.

What development phase is Sintisone in?

Sintisone is in Phase 2.

Drug class: All Corticosteroid drugs
Therapeutic area: All drugs in Immunology

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