Last reviewed · How we verify
SHR0302
SHR0302 is a PI3K inhibitor Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd.. It is currently in Phase 3 development for Advanced solid tumors, Relapsed or refractory multiple myeloma. Also known as: Ivarmacitinib, SHR0302 Ointment 2%, SHR0302 Ointment 1%, SHR0302 Ointment 0.5%.
SHR0302 is a small molecule that targets the PI3K/AKT/mTOR pathway.
SHR0302 is a small molecule drug being studied in clinical trials for various conditions, including atopic dermatitis, rheumatoid arthritis, Crohn's disease, non-segmental vitiligo, and graft-versus-host disease. It is being evaluated in a Phase II study for moderate to severe atopic dermatitis.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | SHR0302 |
|---|---|
| Also known as | Ivarmacitinib, SHR0302 Ointment 2%, SHR0302 Ointment 1%, SHR0302 Ointment 0.5% |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Drug class | PI3K inhibitor |
| Target | PI3K |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
SHR0302 works by inhibiting the PI3K/AKT/mTOR pathway, which is involved in cell proliferation and survival. This inhibition leads to anti-tumor effects. SHR0302 has shown promise in preclinical studies as a potential treatment for various cancers.
Approved indications
- Advanced solid tumors
- Relapsed or refractory multiple myeloma
Common side effects
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma (PHASE2)
- A Trial of SHR0302 Tablets and SHR0302 Base Gel in Patients With Non-segmental Vitiligo (PHASE2)
- A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetic Profile of Single and Multiple Dose Escalation Topical Dermal Administration of SHR0302 Alkali Gel in Healthy Subjects (PHASE1)
- SHR0302 Combined With PD-1/PD-L1 Inhibition for Treatment naïve or Acquired Resistant to Immunology NSCLC (PHASE2)
- A SHR0302 BA Study on Healthy Subjects (PHASE1)
- SHR0302 and Steroid As First Line Therapy for Chronic GVHD (EARLY_PHASE1)
- To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability (PHASE1)
- A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis (PHASE3)
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:
- SHR0302 CI brief — competitive landscape report
- SHR0302 updates RSS · CI watch RSS
- Jiangsu HengRui Medicine Co., Ltd. portfolio CI
Frequently asked questions about SHR0302
What is SHR0302?
How does SHR0302 work?
What is SHR0302 used for?
Who makes SHR0302?
Is SHR0302 also known as anything else?
What drug class is SHR0302 in?
What development phase is SHR0302 in?
What are the side effects of SHR0302?
What does SHR0302 target?
Related
- Drug class: All PI3K inhibitor drugs
- Target: All drugs targeting PI3K
- Manufacturer: Jiangsu HengRui Medicine Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced solid tumors
- Indication: Drugs for Relapsed or refractory multiple myeloma
- Also known as: Ivarmacitinib, SHR0302 Ointment 2%, SHR0302 Ointment 1%, SHR0302 Ointment 0.5%
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing