Last reviewed · How we verify
Dex 21-P
Dex 21-P is a Glucocorticoid receptor antagonist Small molecule drug developed by Quince Therapeutics S.p.A.. It is currently in Phase 2 development for Treatment of rheumatoid arthritis. Also known as: Dexamethasone 21-phosphate.
Dex 21-P is a glucocorticoid receptor antagonist.
Dex 21-P is a small molecule. It is being studied in clinical trials for various types of leukemia, including Recurrent Acute Leukemia, Recurrent B Acute Lymphoblastic Leukemia, and Recurrent Chronic Myelogenous Leukemia.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Dex 21-P |
|---|---|
| Also known as | Dexamethasone 21-phosphate |
| Sponsor | Quince Therapeutics S.p.A. |
| Drug class | Glucocorticoid receptor antagonist |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Rheumatology |
| Phase | Phase 2 |
Mechanism of action
It works by inhibiting the action of glucocorticoids, which are steroid hormones that can cause inflammation and suppress the immune system. This can help reduce inflammation and prevent the immune system from attacking healthy tissues.
Approved indications
- Treatment of rheumatoid arthritis
Common side effects
- Nausea
- Headache
- Diarrhea
- Fatigue
Key clinical trials
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma (PHASE2)
- Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies (PHASE1)
- Erythrocytes-Mediated Delivery Of Dexamethasone 21-Phosphate In Steroid-Dependent Ulcerative Colitis (PHASE2)
- A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide (PHASE3)
- Prophylactic Paracetamol or Dexamethasone for Post-spinal Anesthesia Shivering (PHASE4)
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:
- Dex 21-P CI brief — competitive landscape report
- Dex 21-P updates RSS · CI watch RSS
- Quince Therapeutics S.p.A. portfolio CI
Frequently asked questions about Dex 21-P
What is Dex 21-P?
How does Dex 21-P work?
What is Dex 21-P used for?
Who makes Dex 21-P?
Is Dex 21-P also known as anything else?
What drug class is Dex 21-P in?
What development phase is Dex 21-P in?
What are the side effects of Dex 21-P?
What does Dex 21-P target?
Related
- Drug class: All Glucocorticoid receptor antagonist drugs
- Target: All drugs targeting Glucocorticoid receptor
- Manufacturer: Quince Therapeutics S.p.A. — full pipeline
- Therapeutic area: All drugs in Rheumatology
- Indication: Drugs for Treatment of rheumatoid arthritis
- Also known as: Dexamethasone 21-phosphate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing