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GX-I7
GX-I7 is a FGF21 protein Small molecule drug developed by Genexine, Inc.. It is currently in Phase 2 development for Type 2 diabetes. Also known as: rhIL-7-hyFc, Efineptakin alfa, Efineptakin alfa NT-I7, NT-I7.
GX-I7 is a recombinant human fibroblast growth factor 21 (FGF21) protein.
GX-I7 is being studied in combination with GX-188E vaccination and pembrolizumab for the treatment of advanced, resectable HPV type 16 and/or 18 positive head and neck cancer. The conditions being studied in clinical trials involving GX-I7 include head and neck squamous cell carcinoma, leukopenia, solid tumor, recurrent head and neck squamous cell carcinoma, and recurrent hypopharyngeal squamous cell carcinoma.
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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).
| 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 | GX-I7 |
|---|---|
| Also known as | rhIL-7-hyFc, Efineptakin alfa, Efineptakin alfa NT-I7, NT-I7, TJ107 |
| Sponsor | Genexine, Inc. |
| Drug class | FGF21 protein |
| Target | FGF21 receptor |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 2 |
Mechanism of action
It works by mimicking the action of FGF21, a hormone involved in glucose and lipid metabolism, to improve glycemic control and reduce body weight.
Approved indications
- Type 2 diabetes
Common side effects
- Injection site reaction
Key clinical trials
- HPV 16-positive and/or HPV 18-positive Recurrent and/or For Patients With Metastatic Head and Neck Cancer to Evaluate GX-188E DNA Vaccination, GX-I7 and Nivolumab Combination Therapy (PHASE2)
- Trial of the Combination of GX-188E Vaccination, GX-I7 and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 and/or 18 Positive Head and Neck Cancer (PHASE2)
- Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma (PHASE2)
- NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery (PHASE1)
- NT-I7 for Kaposi Sarcoma in Patients With or Without HIV (PHASE1)
- Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC. (PHASE1)
- Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/KEYNOTE-899) (PHASE1, PHASE2)
- GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients (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:
- GX-I7 CI brief — competitive landscape report
- GX-I7 updates RSS · CI watch RSS
- Genexine, Inc. portfolio CI
Frequently asked questions about GX-I7
What is GX-I7?
How does GX-I7 work?
What is GX-I7 used for?
Who makes GX-I7?
Is GX-I7 also known as anything else?
What drug class is GX-I7 in?
What development phase is GX-I7 in?
What are the side effects of GX-I7?
What does GX-I7 target?
Related
- Drug class: All FGF21 protein drugs
- Target: All drugs targeting FGF21 receptor
- Manufacturer: Genexine, Inc. — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes
- Also known as: rhIL-7-hyFc, Efineptakin alfa, Efineptakin alfa NT-I7, NT-I7, TJ107
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing