NDAINJECTIONINJECTABLE
Approved
Jul 2018
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
DOXERCALCIFEROL (doxercalciferol) by Pfizer is 2 analog that requires metabolic activation to form the active 1α,25-(oh) 2 d 2 metabolite, which binds to the vitamin d receptor (vdr) to result in the selective activation of vitamin d responsive pathways. First approved in 2018.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Doxercalciferol is a vitamin D analog administered by injection that requires metabolic activation to form the active 1α,25-(OH)2D2 metabolite. It binds to the vitamin D receptor to selectively activate vitamin D responsive pathways and reduce PTH levels by inhibiting PTH synthesis and secretion. This product is indicated for management of secondary hyperparathyroidism in patients with chronic kidney disease.
Peak
Product is at peak lifecycle stage with moderate competitive pressure (30%), indicating stable commercial operations and mature team structure within Pfizer's renal/endocrine franchise.
Mechanism of Action
2 analog that requires metabolic activation to form the active 1α,25-(OH) 2 D 2 metabolite, which binds to the vitamin D receptor (VDR) to result in the selective activation of vitamin D responsive pathways. Vitamin D and doxercalciferol have been shown to reduce PTH levels by inhibiting PTH…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients
Started Nov 2008
39 enrolled
Chronic Kidney DiseaseKidney Transplantation
Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
Started Nov 2008
24 enrolled
Chronic Kidney DiseaseSecondary HyperparathyroidismChronic Renal Insufficiency+1 more
A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis
Started Apr 2008
111 enrolled
Moderate to Severe Chronic Plaque Psoriasis
Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
Started Jul 2005
70 enrolled
Secondary HyperparathyroidismRenal FailureChronic Renal Insufficiency
Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer
Started Apr 2002
70 enrolled
Prostate Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.