Last reviewed 2026-04-20 · How we verify

Cloradryn (CLOPREDNOL)

Phase 2 active Small molecule

Cloradryn (generic name: CLOPREDNOL) is a cloprednol drug. It is currently in Phase 2 development.

Cloradryn works by interacting with the body's glucocorticoid receptors.

Cloradryn, also known as Cloprednol, is a small molecule drug in the cloprednol class. Its exact target and mechanism of action are unknown, but it is believed to work by interacting with the body's glucocorticoid receptors. Cloradryn's commercial status and approved indications are unclear, and it is not known whether it is patented or available as a generic medication. Further research is needed to fully understand its properties and potential uses. As a result, key safety considerations and pharmacokinetic parameters, such as half-life and bioavailability, are also unknown.

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	CLOPREDNOL
Drug class	cloprednol
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 2

Mechanism of action

Think of glucocorticoid receptors like special locks in your cells. Cloradryn is a key that fits into these locks, which helps to regulate various bodily functions, such as inflammation and immune response. By binding to these receptors, Cloradryn can influence how your cells behave and respond to different stimuli.

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:

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

Frequently asked questions about Cloradryn

What is Cloradryn?

Cloradryn (CLOPREDNOL) is a cloprednol drug.

How does Cloradryn work?

Cloradryn works by interacting with the body's glucocorticoid receptors.

What is the generic name of Cloradryn?

CLOPREDNOL is the generic (nonproprietary) name of Cloradryn.

What drug class is Cloradryn in?

Cloradryn belongs to the cloprednol class. See all cloprednol drugs at /class/cloprednol.

What development phase is Cloradryn in?

Cloradryn is in Phase 2.

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

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