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Vistusertib (vistusertib)
Vistusertib (generic name: vistusertib) is a Small molecule drug developed by Pfizer Inc.. It is currently in Phase 2 development.
Vistusertib (AZD2014) is a small molecule inhibitor of the serine/threonine-protein kinase mTOR. It is being studied in clinical trials for various types of cancer, including small cell lung cancer, stomach cancer, and diffuse large B-cell lymphoma.
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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). -
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 | 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 | vistusertib |
|---|---|
| Sponsor | Pfizer Inc. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
- Nausea
- Fatigue
- Decreased appetite
- Vomiting
- Anaemia
- Constipation
- Cough
- Dyspnoea
- Diarrhoea
- Hypokalaemia
- Arthralgia
- Asthenia
Key clinical trials
- AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer (PHASE1)
- European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors (PHASE1, PHASE2)
- mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian (PHASE1)
- Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer (PHASE1)
- Phase II Umbrella Study of Novel Anti-cancer Agents in Participants With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (PHASE2)
- National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer (PHASE2)
- SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer (PHASE2)
- Japanese Phase I Study of AZD2014 in Advanced Solid Malignancies (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:
- Vistusertib CI brief — competitive landscape report
- Vistusertib updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Vistusertib
What is Vistusertib?
Who makes Vistusertib?
What is the generic name of Vistusertib?
What development phase is Vistusertib in?
What are the side effects of Vistusertib?
Related
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing