Last reviewed 2026-05-24 · How we verify

SHR8554；Itraconazole

Jiangsu HengRui Medicine Co., Ltd. · Phase 1 active Small molecule ✓ Verified May 2026

SHR8554；Itraconazole is a Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd.. It is currently in Phase 1 development.

SHR8554 is a compound being studied in a Phase 1 clinical trial, where it is being evaluated in combination with itraconazole in healthy adult subjects. The purpose of this trial is to estimate the effects of multiple-dose administration of itraconazole on the pharmacokinetics of SHR8554.

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	SHR8554；Itraconazole
Sponsor	Jiangsu HengRui Medicine 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

A Study to Evaluate the Effect of Itraconazole on Pharmacokinetics (PK) of SHR8554 in Healthy Adult Subjects (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:

SHR8554；Itraconazole CI brief — competitive landscape report
SHR8554；Itraconazole updates RSS · CI watch RSS
Jiangsu HengRui Medicine Co., Ltd. portfolio CI

Frequently asked questions about SHR8554；Itraconazole

What is SHR8554；Itraconazole?

SHR8554；Itraconazole is a Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd..

Who makes SHR8554；Itraconazole?

SHR8554；Itraconazole is developed by Jiangsu HengRui Medicine Co., Ltd. (see full Jiangsu HengRui Medicine Co., Ltd. pipeline at /company/jiangsu-hengrui-medicine-co-ltd).

What development phase is SHR8554；Itraconazole in?

SHR8554；Itraconazole is in Phase 1.

Manufacturer: Jiangsu HengRui Medicine Co., Ltd. — full pipeline

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