VECTICAL (calcitriol) · GALDERMA LABS LP
Vectical (calcitriol) ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adults and pediatric patients 2 years of age and older. Use in patients with known or suspected disorders of calcium metabolism is a limitation of use, as safety and efficacy have not been evaluated in this population.
How VECTICAL Works
While calcitriol is the active metabolite of vitamin D3, the specific mechanism of action of Vectical in the treatment of psoriasis has not been established.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-01-23
- Routes
- TOPICAL
- Dosage Forms
- OINTMENT
VECTICAL Approval History
What VECTICAL Treats
1 indicationsVECTICAL is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
VECTICAL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to VECTICAL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
GALDERMA LABS LP's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
29 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02962102 ACTIVATE-AKI results posted | 2016P002527 5K23DK106448 | Ph 2 | completed | Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury |
| NCT02859896 results posted | LPS14314 U1111-1178-4657 | Ph 3 | terminated | Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis |
| NCT02224144 results posted | AAAM7850 | Ph 2 | completed | Bone Mass and Strength After Kidney Transplantation |
| NCT01350934 results posted | 0217A-264 | Ph 4 | completed | A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264) |
| NCT04386811 | 2000028035 | Ph 1 | terminated | Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD: a Proof-of-concept Tele-health Study of Stimulant-induced Improvement in Neurocognitive Functioning. |
| NCT01725113 ECRIP results posted | 12027 | Ph 4 | terminated | Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol |
| NCT04801303 CalcitriolFA | IdIBGI 2020-001092-32 | Ph 4 | completed | Evaluation of the Effects of Calcitriol's in the Neurological Symptoms of Friedreich's Ataxia Patients |
| NCT05765617 | NAP03 | Ph 2 | completed | Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients |
| NCT01293682 results posted | 25741 | Ph 2 | completed | Effects of High Dose Calcitriol in Breast Cancer Patients |
| NCT02061384 RA-2 results posted | STUDY00000564 | Ph 2 | completed | RA-2 13-cis Retinoic Acid (Isotretinoin) |
| NCT00925704 results posted | SPD405-129 | Ph 1 | completed | The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers |
| NCT02125279 results posted | RD.06.SPR.18131 | Ph 4 | completed | Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis |
| NCT01689441 results posted | 2012P001755 | Ph 2 | completed | Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis |
| NCT00904033 results posted | RSRB00025478 | Ph 2 | completed | Calcitriol, Physical Activity, and Bone Health in Cancer Survivors |
| NCT01384539 results posted | 11-0521 5K23DK087859 | Ph 3 | completed | Vitamin D and Arterial Function in Patients With Chronic Kidney Disease |
| NCT00794547 results posted | UMCC 2008.042 HUM 21242 | Ph 1, Ph 2 | terminated | Phase I/II Calcitriol in Lung Cancer |
| NCT03140449 | 201306009MINB | Ph 3 | completed | Topical Rapamycin and Calcitriol for Angiofibroma of Tuberous Sclerosis |
| NCT00953849 results posted | CLIN-003-09S | Ph 1, Ph 2 | completed | Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity |
| NCT02282813 results posted | CTAP101-CL-3003 | Ph 3 | completed | Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002 |
| NCT00508898 | CRE-2007.261-T | Ph 4 | withdrawn | The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria |
| NCT01265615 results posted | VDCRS03 | Ph 4 | completed | Paricalcitol Versus Calcitriol for the Management of Renocardiac Syndrome in Renal Transplant Patients |
| NCT01358045 | MEC 10-2-088 | Ph 2 | completed | Topical Vitamin D3, Diclofenac or a Combination of Both to Treat Basal Cell Carcinoma |
| NCT00823303 PACE results posted | 22095 | Ph 4 | completed | Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT) |
| NCT01768351 | PCX1234 paranemia | Ph 4 | completed | Paricalcitol Effect on Anemia in CKD |
| NCT01748396 | SNUH-FGF23 | Ph 4 | completed | Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol |
| NCT00623974 results posted | 2006-0562 | Ph 2 | terminated | Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia |
| NCT01388517 | PA-CALTAC | Ph 4 | completed | Clinical Trial of 0.0003% Calcitriol, 0.1% Tacrolimus, and Petrolatum for the Treatment of Pityriasis Alba |
| NCT00664430 results posted | W10-131 | Ph 4 | terminated | Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects |
| NCT07670611 VITD-CHOL | 0947/68 | Ph 4 | recruiting | Vitamin D2 vs Vitamin D2 Plus Calcitriol in Cholestatic Children With Vitamin D Deficiency |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VECTICAL FDA Label Details
Indications & Usage
FDA Label (PDF)VECTICAL Ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adult and pediatric patients 2 years and older. Limitations of Use The safety and effectiveness of VECTICAL Ointment in patients with known or suspected disorders of calcium metabolism have not been evaluated. 1.1 Indication VECTICAL Ointment is indicated for the topical treatment of mild to moderate plaque psoriasis in adults and pediatric patients 2 years and older. 1.2 Limitations of Use The safety and effectiveness of VECTICAL Ointment in patients with known or suspected diso...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment