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Randomisation course 2 ADxE versus FLADx
Randomisation course 2 ADxE versus FLADx is a Small molecule drug developed by Vastra Gotaland Region. It is currently in Phase 3 development for Treatment of various autoimmune diseases.
ADxE and FLADx are both involved in the regulation of the immune system.
In the NOPHO-DBH AML 2012 Protocol, a clinical trial was conducted to compare the effectiveness of two treatments for pediatric acute myeloblastic leukemia: Randomisation course 2 ADxE versus FLADx. The trial focused on the treatment of children and adolescents with acute myeloid leukemia aged 0-18 years.
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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). -
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 | Randomisation course 2 ADxE versus FLADx |
|---|---|
| Sponsor | Vastra Gotaland Region |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
ADxE and FLADx are both involved in the regulation of the immune system. They work by targeting specific pathways to modulate immune responses. However, the exact mechanisms of action for ADxE and FLADx are not well understood.
Approved indications
- Treatment of various autoimmune diseases
Common side effects
- Immune-related adverse events
Key clinical trials
- Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years (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:
- Randomisation course 2 ADxE versus FLADx CI brief — competitive landscape report
- Randomisation course 2 ADxE versus FLADx updates RSS · CI watch RSS
- Vastra Gotaland Region portfolio CI
Frequently asked questions about Randomisation course 2 ADxE versus FLADx
What is Randomisation course 2 ADxE versus FLADx?
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Related
- Manufacturer: Vastra Gotaland Region — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Treatment of various autoimmune diseases
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing