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Recombinant Human Interleukin-11
Recombinant Human Interleukin-11 is a Cytokine; thrombopoietic agent Small molecule drug developed by Zhejiang Cancer Hospital. It is currently in Phase 3 development for Prevention and treatment of chemotherapy-induced thrombocytopenia in cancer patients.
Recombinant human interleukin-11 (rhIL-11) stimulates megakaryocyte maturation and platelet production to prevent or treat chemotherapy-induced thrombocytopenia.
Recombinant Human Interleukin-11 is being studied in clinical trials for various conditions, including Von Willebrand Disease, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, and Follicular Lymphoma. It has been used in a Phase II study to evaluate its hemostatic efficacy in Von Willebrand Disease.
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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 | Recombinant Human Interleukin-11 |
|---|---|
| Sponsor | Zhejiang Cancer Hospital |
| Drug class | Cytokine; thrombopoietic agent |
| Target | IL-11 receptor (IL-11R) |
| Modality | Small molecule |
| Therapeutic area | Oncology; Hematology |
| Phase | Phase 3 |
Mechanism of action
IL-11 is a pleiotropic cytokine that acts on bone marrow progenitor cells to promote megakaryocyte proliferation and differentiation, leading to increased platelet production. It is used to mitigate thrombocytopenia (low platelet counts) caused by myelosuppressive chemotherapy, reducing the need for platelet transfusions and allowing patients to maintain adequate platelet levels during cancer treatment.
Approved indications
- Prevention and treatment of chemotherapy-induced thrombocytopenia in cancer patients
Common side effects
- Fluid retention / edema
- Arrhythmias / atrial fibrillation
- Dyspnea
- Headache
- Injection site reactions
Key clinical trials
- A Multicenter, Open-label, Randomized Controlled Trial Evaluating the Efficacy and Safety of Romiplostim N01 in the Treatment of Thrombocytopenia Associated With Concurrent/Sequential Chemoradiotherapy and Chemotherapy Combined With/Without Immunotherapy in Solid Tumors (NA)
- FRIENDS-01：A Multicenter Open-label Randomized Controlled Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11 (PHASE3)
- Clinical Study Protocol of Maintenance Therapy With Venetoclax in Elderly Patients With AML in First Complete Remission (NA)
- To Evaluate Thrombosis Risk in Chemotherapy Patients With Solid Tumors Who Receiving Thrombocytopenia Treatment
- Measurement of Oncostatin M, Leukemia Inhibitory Factor and Interleukin-11 Levels of Patients With Periodontal Disease (NA)
- A Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11 (PHASE3)
- Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis (PHASE3)
- IL-11 in Adults With Von Willebrand Disease Undergoing Surgery (PHASE2)
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:
- Recombinant Human Interleukin-11 CI brief — competitive landscape report
- Recombinant Human Interleukin-11 updates RSS · CI watch RSS
- Zhejiang Cancer Hospital portfolio CI
Frequently asked questions about Recombinant Human Interleukin-11
What is Recombinant Human Interleukin-11?
How does Recombinant Human Interleukin-11 work?
What is Recombinant Human Interleukin-11 used for?
Who makes Recombinant Human Interleukin-11?
What drug class is Recombinant Human Interleukin-11 in?
What development phase is Recombinant Human Interleukin-11 in?
What are the side effects of Recombinant Human Interleukin-11?
What does Recombinant Human Interleukin-11 target?
Related
- Drug class: All Cytokine; thrombopoietic agent drugs
- Target: All drugs targeting IL-11 receptor (IL-11R)
- Manufacturer: Zhejiang Cancer Hospital — full pipeline
- Therapeutic area: All drugs in Oncology; Hematology
- Indication: Drugs for Prevention and treatment of chemotherapy-induced thrombocytopenia in cancer patients
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing