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allo-APZ2-CVU
allo-APZ2-CVU is a Biologic drug developed by RHEACELL GmbH & Co. KG. It is currently in Phase 3 development for Atrial fibrillation for stroke prevention. Also known as: Skin-derived ABCB5-positive dermal mesenchymal stromal cells.
Allo-APZ2-CVU is a small molecule that targets the CVU receptor.
Allo-APZ2-CVU is a small molecule that targets the CVU receptor. Used for Atrial fibrillation for stroke prevention.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | allo-APZ2-CVU |
|---|---|
| Also known as | Skin-derived ABCB5-positive dermal mesenchymal stromal cells |
| Sponsor | RHEACELL GmbH & Co. KG |
| Target | CVU receptor |
| Modality | Biologic |
| Phase | Phase 3 |
Mechanism of action
The exact mechanism of action of allo-APZ2-CVU is not well understood, but it is believed to modulate the CVU receptor, leading to therapeutic effects.
Approved indications
- Atrial fibrillation for stroke prevention
Common side effects
- Nausea
- Headache
- Dizziness
Key clinical trials
- Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of CVU (Phase IIb) (PHASE2)
- Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III) (PHASE3)
- Allogeneic ABCB5-positive Stem Cells for Treatment of CVU (PHASE1, 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:
- allo-APZ2-CVU CI brief — competitive landscape report
- allo-APZ2-CVU updates RSS · CI watch RSS
- RHEACELL GmbH & Co. KG portfolio CI
Frequently asked questions about allo-APZ2-CVU
What is allo-APZ2-CVU?
How does allo-APZ2-CVU work?
What is allo-APZ2-CVU used for?
Who makes allo-APZ2-CVU?
Is allo-APZ2-CVU also known as anything else?
What development phase is allo-APZ2-CVU in?
What are the side effects of allo-APZ2-CVU?
What does allo-APZ2-CVU target?
Related
- Target: All drugs targeting CVU receptor
- Manufacturer: RHEACELL GmbH & Co. KG — full pipeline
- Indication: Drugs for Atrial fibrillation for stroke prevention
- Also known as: Skin-derived ABCB5-positive dermal mesenchymal stromal cells
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing