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Originator
Originator is a Biologic drug developed by Opal Rheumatology Ltd.. It is currently in Phase 2 development. Also known as: Enbrel, All other originator anti-TNF agents.
Pirtobrutinib, also known as LY3527727, is a medication being studied in clinical trials for various conditions, including Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma, and Rheumatoid Arthritis. The medication is being investigated in combination with other treatments, such as TNFi and Abatacept, in trials sponsored by Eli Lilly and Company.
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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 | Originator |
|---|---|
| Also known as | Enbrel, All other originator anti-TNF agents |
| Sponsor | Opal Rheumatology Ltd. |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis (PHASE3)
- A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis
- A Study of (LY3527727) Pirtobrutinib in Participants With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma (PHASE4)
- A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib (PHASE4)
- ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar
- Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator
- Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients (PHASE4)
- ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar
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:
- Originator CI brief — competitive landscape report
- Originator updates RSS · CI watch RSS
- Opal Rheumatology Ltd. portfolio CI
Frequently asked questions about Originator
What is Originator?
Who makes Originator?
Is Originator also known as anything else?
What development phase is Originator in?
Related
- Manufacturer: Opal Rheumatology Ltd. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Enbrel, All other originator anti-TNF agents
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing