Last reviewed · How we verify
X-82 oral
X-82 oral is a Small molecule drug developed by Tyrogenex. It is currently in Phase 1 development.
X-82 oral is a platelet-derived growth factor receptor inhibitor, a type of drug that falls under the class of INHIBITOR. It has been studied in clinical trials for various conditions, including Myopic Choroidal Neovascularisation, Advanced Malignant Solid Tumors, and Exudative Macular Degeneration.
-
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).
| 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 | X-82 oral |
|---|---|
| Sponsor | Tyrogenex |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Vorolanib + Atezolizumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer (PHASE2)
- Study of Challenge Meditech 082 (CM082) Tablets in Patients With Advanced Malignant Solid Tumors (PHASE1)
- Safety Study of X-82 in Patients With Advanced Solid Tumors (PHASE1)
- VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Everolimus for Treating Patients With Pancreatic Neuroendocrine Tumors (PHASE1, PHASE2)
- CM082 in Patients With Myopic Choroidal Neovascularization (CNV) (PHASE1)
- CM082 Combined With Everolimus in Chinese Patients With Metastatic Renal Cell Carcinoma (PHASE3)
- Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors (PHASE1)
- Phase 1 Study of CM082 in Patients With wAMD (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:
- X-82 oral CI brief — competitive landscape report
- X-82 oral updates RSS · CI watch RSS
- Tyrogenex portfolio CI
Frequently asked questions about X-82 oral
What is X-82 oral?
Who makes X-82 oral?
What development phase is X-82 oral in?
Related
- Manufacturer: Tyrogenex — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing