Pefcalcitol

Generic Name: Pefcalcitol

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₃₄F_₅NO_₄

CAS Number: 381212-03-9

Unique Ingredient Identifier: KT5224XSHW

Background: Pefcalcitol has been investigated for the basic science of Psoriasis.

Clinical Trials

A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pefcalcitol Ointment, 0.005%, Applied Topically Twice Daily (BID) for 8 Weeks in Adolescent Subjects 12 to < 17 Years of Age With Plaque Psoriasis

Phase 2

Withdrawn

Conditions: Psoriasis

Interventions: Drug: pefcalcitol ointment, 0.005%

First Posted Date: 2016-11-22

Last Posted Date: 2023-04-18

Lead Sponsor: Maruho Co., Ltd.

Registration Number: NCT02970331

Skin Safety Study to Evaluate the Sensitizing Potential in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: M518101
Drug: M518101 Vehicle
Other: Sodium lauryl sulfate
Other: Saline

First Posted Date: 2014-10-06

Last Posted Date: 2015-08-11

Lead Sponsor: Maruho North America Inc.

Target Recruit Count: 240

Registration Number: NCT02256930

Locations: 🇺🇸
TKL research, Fair Lawn, New Jersey, United States

Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: M518101
Drug: M518101 Vehicle
Other: saline
Other: sodium lauryl sulfate

First Posted Date: 2014-08-27

Last Posted Date: 2015-03-30

Lead Sponsor: Maruho North America Inc.

Target Recruit Count: 30

Registration Number: NCT02227069

Locations: 🇺🇸
TKL research, Fair Lawn, New Jersey, United States

Efficacy Study Comparing Topical M518101 and Vitamin D3 in Adult Psoriasis Patients

Phase 3

Completed

Conditions: Plaque Psoriasis

Interventions: Drug: M518101

First Posted Date: 2013-11-21

Last Posted Date: 2015-12-31

Lead Sponsor: Maruho Europe Limited

Target Recruit Count: 788

Registration Number: NCT01989429

Locations: 🇧🇬
DCC "Chaika" EOOD, Varna, Bulgaria
🇩🇪
Universitatsklinikum Schleswig-Holstein, Lubeck, Germany
🇦🇹
Universitätsklinik für Dermatologie und Venerologie,, Graz, Austria

and more 3 locations

Long Term Study to Evaluate Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis

Phase 3

Completed

Conditions: Psoriasis

Interventions: Drug: M518101

First Posted Date: 2013-07-25

Last Posted Date: 2015-09-02

Lead Sponsor: Maruho North America Inc.

Target Recruit Count: 480

Registration Number: NCT01908595

Locations: 🇺🇸
Medical Center for Clinical Research, San Diego, California, United States
🇺🇸
Dermatology and Aesthetic Center Skin Care, Boca Raton, Florida, United States
🇺🇸
Renstar Medical Research, Ocala, Florida, United States

and more 28 locations

Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis

Phase 3

Completed

Conditions: Psoriasis

Interventions: Drug: M518101
Drug: Vehicle

First Posted Date: 2013-06-17

Last Posted Date: 2015-09-02

Lead Sponsor: Maruho North America Inc.

Target Recruit Count: 542

Registration Number: NCT01878461

Locations: 🇺🇸
T Joseph Raoof, Encino, California, United States
🇺🇸
Agave Clinical Research, Mesa, Arizona, United States
🇺🇸
Grekin Skin Institute, Warren, Michigan, United States

and more 30 locations

Study to Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis

Phase 3

Completed

Conditions: Psoriasis

Interventions: Drug: M518101
Drug: Vehicle

First Posted Date: 2013-06-10

Last Posted Date: 2015-09-02

Lead Sponsor: Maruho North America Inc.

Target Recruit Count: 537

Registration Number: NCT01873677

Locations: 🇺🇸
Coastal Clinical Research, Mobile, Alabama, United States
🇺🇸
The Center for Skin Research, Houston, Texas, United States
🇺🇸
Dawes Fretzin Clinical Research Group, Indianapolis, Indiana, United States

and more 27 locations

Study to Evaluate the Pharmacokinetics and the Safety of M518101 in Plaque Psoriasis Patients

Phase 1

Completed

Conditions: Psoriasis

Interventions: Drug: M518101
Drug: Vehicle

First Posted Date: 2013-05-03

Last Posted Date: 2013-08-19

Lead Sponsor: Maruho North America Inc.

Target Recruit Count: 30

Registration Number: NCT01844973

Locations: 🇺🇸
Orenge County Research Center, Tustin, California, United States

Study to Investigate the Efficacy and the Safety of M518101 in Plaque Psoriasis Patients

Phase 2

Completed

Conditions: Plaque Psoriasis

Interventions: Drug: Dovonex
Drug: M518101
Drug: placebo

First Posted Date: 2011-02-23

Last Posted Date: 2015-11-05

Lead Sponsor: Maruho Co., Ltd.

Target Recruit Count: 294

Registration Number: NCT01301157

Locations: 🇺🇸
Sierra Medical Research, Fresno, California, United States
🇺🇸
DermResearchCenter of New York, Inc, Stony Brook, New York, United States
🇺🇸
University of Alabama (UAB) Dermatology, Birmingham, Alabama, United States

and more 27 locations

Study to Investigate the Efficacy and the Safety of M518101 in Psoriasis Patients

Phase 2

Completed

Conditions: Plaque Psoriasis

First Posted Date: 2009-04-20

Last Posted Date: 2010-11-03

Lead Sponsor: Maruho Co., Ltd.

Registration Number: NCT00884169

Locations: 🇬🇧
St Thomas' Hospital, London, United Kingdom

Drug Development Updates

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