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Oxarol (MAXACALCITOL)
Oxarol (generic name: MAXACALCITOL) is a maxacalcitol drug. It is currently in Phase 3 development for Pustular psoriasis.
Maxacalcitol works by binding to the Vitamin D3 receptor, which helps regulate skin cell growth and differentiation.
Oxarol, also known as Maxacalcitol, is a small molecule used in the treatment of Secondary Hyperparathyroidism, Chronic Kidney Disease on Hemodialysis, and Hemodialysis. It is administered in various doses, including 1.0 μg/day and 0.25 μg/day Alfacalcidol, and has been studied in clinical trials as a maintenance therapy after intravenous treatment.
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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 | MAXACALCITOL |
|---|---|
| Drug class | maxacalcitol |
| Target | Vitamin D3 receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Imagine your skin cells are like a row of houses. The Vitamin D3 receptor is like the city planner that decides how many houses to build and where to put them. Maxacalcitol is like a special instruction that tells the city planner to slow down the building process, which helps to reduce the severity of pustular psoriasis.
Approved indications
- Pustular psoriasis
Common side effects
- Shunt stenosis
- Shunt occlusion
- Peripheral arterial occlusive disease
- Angina unstable
- Cardiac failure
- Shunt infection
- Cerebral infarction
- Shunt aneurysm
- Hypocalcaemia
Key clinical trials
- Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT) (NA)
- Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism (PHASE3)
- Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis (PHASE2)
- Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism (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:
- Oxarol CI brief — competitive landscape report
- Oxarol updates RSS · CI watch RSS
Frequently asked questions about Oxarol
What is Oxarol?
How does Oxarol work?
What is Oxarol used for?
What is the generic name of Oxarol?
What drug class is Oxarol in?
What development phase is Oxarol in?
What are the side effects of Oxarol?
What does Oxarol target?
Related
- Drug class: All maxacalcitol drugs
- Target: All drugs targeting Vitamin D3 receptor
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Pustular psoriasis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing