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ZE 50-0134
ZE 50-0134 is a Small molecule drug developed by Lomond Therapeutics Holdings, Inc.. It is currently in Phase 1 development.
ZE 50-0134 is a study intervention for patients with Acute Myeloid Leukemia, CLL / SLL, CLL, and SLL. It is being studied in combination with Azacitidine in a Phase 1b clinical trial, NCT07303660, sponsored by Lomond Therapeutics Holdings, Inc.
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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 | ZE 50-0134 |
|---|---|
| Sponsor | Lomond Therapeutics Holdings, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Phase 1b Study of Lonitoclax + Azacitidine in Acute Myeloid Leukemia Patients (PHASE1)
- A Phase 1 Study of ZE50-0134 in Relapsed and Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Select Low-grad Lymphomas (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:
- ZE 50-0134 CI brief — competitive landscape report
- ZE 50-0134 updates RSS · CI watch RSS
- Lomond Therapeutics Holdings, Inc. portfolio CI
Frequently asked questions about ZE 50-0134
What is ZE 50-0134?
Who makes ZE 50-0134?
What development phase is ZE 50-0134 in?
Related
- Manufacturer: Lomond Therapeutics Holdings, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing