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Tiragolumab (tiragolumab)
Tiragolumab (generic name: tiragolumab) is a Monoclonal antibody drug developed by Pfizer Inc.. It is currently in Phase 1 development.
Tiragolumab is a humanized monoclonal antibody that targets the T-cell immunoreceptor with Ig and ITIM domains (TIGIT) pathway. It is being studied in combination with other immunotherapy agents, such as atezolizumab, for the treatment of various cancers, including urothelial carcinoma, bladder cancer, and advanced lung cancer.
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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 | tiragolumab |
|---|---|
| Sponsor | Pfizer Inc. |
| Modality | Monoclonal antibody |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
- Anaemia
- Neutrophil count decreased
- Nausea
- White blood cell count decreased
- Decreased appetite
- Constipation
- Alopecia
- Fatigue
- Platelet count decreased
- Diarrhoea
- Neutropenia
- Vomiting
Key clinical trials
- A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (PHASE1, PHASE2)
- Tiragolumab and Atezolizumab for the Treatment of Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors (PHASE1, PHASE2)
- Targeting PD-L1 and TIGIT in Tumors With Tertiary Lymphoid Structures (PHASE2)
- A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study (PHASE3)
- A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer (PHASE2)
- A Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Participants With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (PHASE2)
- A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC) (PHASE1)
- Phase 2 Trial of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab in Patients With Newly Diagnosed PD-L1 CPS Positive Resectable Stage 3-4 Oral Cavity Squamous Cell Carcinoma (OCSCC). (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:
- Tiragolumab CI brief — competitive landscape report
- Tiragolumab updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Tiragolumab
What is Tiragolumab?
Who makes Tiragolumab?
What is the generic name of Tiragolumab?
What development phase is Tiragolumab in?
What are the side effects of Tiragolumab?
Related
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing