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RYZ101 Dose Level -1
RYZ101 Dose Level -1 is a Small molecule drug developed by RayzeBio, Inc.. It is currently in Phase 1 development.
RYZ101 Dose Level -1 is being studied in combination with standard of care (SoC) in subjects with SSTR+ ES-SCLC (Extensive Stage Small Cell Lung Cancer) and other conditions such as GEP-NET (Gastroenteropancreatic Neuroendocrine Tumor). The conditions studied also include Gastroenteropancreatic Neuroendocrine Tumor Disease and Neuroendocrine Tumors.
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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).
| 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 | RYZ101 Dose Level -1 |
|---|---|
| Sponsor | RayzeBio, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs. (PHASE1, PHASE2)
- Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy (PHASE3)
- Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC (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:
- RYZ101 Dose Level -1 CI brief — competitive landscape report
- RYZ101 Dose Level -1 updates RSS · CI watch RSS
- RayzeBio, Inc. portfolio CI
Frequently asked questions about RYZ101 Dose Level -1
What is RYZ101 Dose Level -1?
Who makes RYZ101 Dose Level -1?
What development phase is RYZ101 Dose Level -1 in?
Related
- Manufacturer: RayzeBio, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing