Last reviewed · How we verify
allo-APZ2-OTS
allo-APZ2-OTS is a S1P receptor modulator Small molecule drug developed by RHEACELL GmbH & Co. KG. It is currently in Phase 3 development for Multiple sclerosis.
Allo-APZ2-OTS is a small molecule that targets the sphingosine-1-phosphate receptor 1 (S1PR1).
Allo-APZ2-OTS is a small molecule being studied in a Phase III clinical trial for the treatment of Epidermolysis Bullosa. The trial is a double-blind, randomized, placebo-controlled study that involves the administration of allo-APZ2-OTS to patients with Epidermolysis Bullosa.
-
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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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-OTS |
|---|---|
| Sponsor | RHEACELL GmbH & Co. KG |
| Drug class | S1P receptor modulator |
| Target | S1PR1 |
| Modality | Small molecule |
| Therapeutic area | Autoimmune diseases |
| Phase | Phase 3 |
Mechanism of action
By binding to S1PR1, allo-APZ2-OTS modulates the immune response and has shown potential in treating autoimmune diseases. The exact mechanism of action is still being researched, but it is believed to involve the regulation of immune cell trafficking and function.
Approved indications
- Multiple sclerosis
Common side effects
- Headache
- Nausea
- Diarrhea
Key clinical trials
- Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III) (PHASE3)
- Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III, Cross-over) (PHASE3)
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-OTS CI brief — competitive landscape report
- allo-APZ2-OTS updates RSS · CI watch RSS
- RHEACELL GmbH & Co. KG portfolio CI
Frequently asked questions about allo-APZ2-OTS
What is allo-APZ2-OTS?
How does allo-APZ2-OTS work?
What is allo-APZ2-OTS used for?
Who makes allo-APZ2-OTS?
What drug class is allo-APZ2-OTS in?
What development phase is allo-APZ2-OTS in?
What are the side effects of allo-APZ2-OTS?
What does allo-APZ2-OTS target?
Related
- Drug class: All S1P receptor modulator drugs
- Target: All drugs targeting S1PR1
- Manufacturer: RHEACELL GmbH & Co. KG — full pipeline
- Therapeutic area: All drugs in Autoimmune diseases
- Indication: Drugs for Multiple sclerosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing