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Ulixertinib (ulixertinib)
Ulixertinib (generic name: ulixertinib) is a drug developed by Pfizer Inc.. It is currently in Phase 1 development.
Ulixertinib is a small molecule used in clinical trials for various conditions, including Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Gliomas, and Advanced Malignant Solid Neoplasm. It is also known as BVD-523, BVD-ERK, and VRT-752271, and has been studied in a Phase 1 trial to investigate its absorption, metabolism, and excretion.
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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). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | ulixertinib |
|---|---|
| Sponsor | Pfizer Inc. |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
- Aspartate aminotransferase increased
- Vomiting
- Rash maculo-papular
- Anemia
- Fatigue
- Diarrhea
- Hypoalbuminemia
- Nausea
- Hypocalcemia
- Alanine aminotransferase increased
- Platelet count decreased
- Headache
Key clinical trials
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (PHASE2)
- Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy (PHASE1)
- Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Gliomas (EARLY_PHASE1)
- A Phase II Study of BVD-523 in Metastatic Uveal Melanoma (PHASE2)
- Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) (PHASE2)
- Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies
- Ulixertinib in People With Histiocytic Neoplasms (PHASE2)
- A Study of Ruxolitinib in Combination With Ulixertinib in People With Myelofibrosis (PHASE1, 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:
- Ulixertinib CI brief — competitive landscape report
- Ulixertinib updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Ulixertinib
What is Ulixertinib?
Who makes Ulixertinib?
What is the generic name of Ulixertinib?
What development phase is Ulixertinib in?
What are the side effects of Ulixertinib?
Related
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing