Rayaldee

(Calcifediol)

ApprovedSmall molecule

OOrganon and Co

Rayaldee is one of 97 small molecule programs targeting COVID-19. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

COVID-19Active, not recruiting

Secondary HyperparathyroidismActive, not recruiting

Vitamin D DeficiencyCompleted

Pulmonary Arterial HypertensionNot yet recruiting

COVID-19Preclinical

Active, not recruiting

Secondary HyperparathyroidismApproved

Active, not recruiting

Vitamin D DeficiencyApproved

Completed

Pulmonary Arterial HypertensionApproved

Not yet recruiting

Competition

Competitive Landscape

317 competitors in COVID-19

#DrugCompanyPhaseTrials

Rayaldee

OOrganon and Co

Approved

1 2

Stivarga

Bayer

Preclinical

1 3

Aimovig

Amgen

Preclinical

1 4

Aldactone

Pfizer

Preclinical

1 5

Nexavar

Bayer

Preclinical

1 6

Calciferol

Activella

Tricor

1 9

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

1 10

Benadryl

PParkedale

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Post-ApprovalNot yet recruiting

Pulmonary Arterial Hypertension

NCT06258850

Clinical

Trials by Indication[1]

Vitamin D Deficiency3 trials

The Effect of Supplementation of Vitamin D Deficiency in Older People With Acute Hip Fracture:

Completed·LLeonor Cuadra Llopart·Phase 4·NCT03213886·50 enrolled

Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiency

Completed·FFaes Farma, S.A.·Phase 2/3·NCT04735926·674 enrolled

Efficacy of Calcifediol Supplementation in Asthma Control in Asthmatic Patients With Vitamin D Deficiency (ACViD)

Completed·MMurciaSalud·Phase 4·NCT02805907·112 enrolled

Secondary Hyperparathyroidism2 trials

Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency

Completed·OOPKO Health, Inc.·Phase 4·NCT03588884·69 enrolled

Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation.

Completed·FFundación Senefro·Phase 4·NCT01939977·148 enrolled

Vitamin D2 trials

Vitamin D Status in Young Medical Residents

Completed·MMaimónides Biomedical Research Institute of Córdoba··NCT07479303·30 enrolled

25-Hydroxyvitamin D Pharmacokinetic Study

Completed·—·Phase 1·NCT03401541·16 enrolled

Pulmonary Arterial Hypertension1 trial

REstoration of VItamin D in Pulmonary Arterial Hypertension

Not yet recruiting·PParc de Salut Mar·Phase 4·NCT06258850·102 enrolled

Efficacy1 trial

Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI

Terminated·OOPKO Health, Inc.·Phase 2·NCT03602261·44 enrolled

4 more indications

COVID-191 trial

Calcifediol in the Treatment of SARS-CoV-2 Disease (COVID-19).

Completed·—··NCT06279910·230 enrolled

Acute Kidney Injury1 trial

Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury

Completed·DDavid Leaf·Phase 2·NCT02962102·150 enrolled

Acute Myocardial Infarction1 trial

Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction (VITDAMI)

Completed·IInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz·Phase 3·NCT02548364·109 enrolled

Treatment1 trial

Calcifediol in the Treatment of COVID 19

Completed·MMaimónides Biomedical Research Institute of Córdoba··NCT05819918·728 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

CALDEROL

NDA NDA018312

Jun 17, 2016

RAYALDEE

NDA NDA208010

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Calcifediol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Calcifediol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Calcifediol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208010). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Rayaldee. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Organon and Co company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: OOrganon and Co

Patent Landscape[5]

Patent Cliff

Feb 2, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10213442Feb 2, 2027

9943530Feb 2, 2027

8906410Feb 2, 2027

8207149Apr 25, 2028

9498486Apr 25, 2028

11 more patents

8778373Apr 25, 2028

11154509Apr 25, 2028

9408858Apr 25, 2028

9925147Apr 25, 2028

8361488Jul 19, 2028

8426391Aug 27, 2028

11801253Sep 7, 2030

11253528Mar 14, 2034

10357502Mar 14, 2034

10300078Mar 14, 2034

9861644Mar 14, 2034

Rayaldee

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Vitamin D Deficiency3 trials

Secondary Hyperparathyroidism2 trials

Vitamin D2 trials

Pulmonary Arterial Hypertension1 trial

Efficacy1 trial

COVID-191 trial

Acute Kidney Injury1 trial

Acute Myocardial Infarction1 trial

Treatment1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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