Serlopitant

Generic Name: Serlopitant

Drug Type: Small Molecule

Chemical Formula: C_₂₉H_₂₈F_₇NO_₂

CAS Number: 860642-69-9

Unique Ingredient Identifier: 277V92K32B

Background: Serlopitant has been investigated for the treatment of Prurigo Nodularis.

Clinical Trials

Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin

Phase 2

Completed

Conditions: Pruritus

Interventions: Drug: Matching Placebo Tablets
Drug: 5 mg Serlopitant Tablets

First Posted Date: 2019-02-15

Last Posted Date: 2021-05-20

Lead Sponsor: Vyne Therapeutics Inc.

Target Recruit Count: 233

Registration Number: NCT03841331

Locations: 🇺🇸
Study Site 807, Miami, Florida, United States
🇺🇸
Study Site 121, Ocean Township, New Jersey, United States
🇺🇸
Study Site 813, Las Vegas, Nevada, United States

and more 38 locations

A Neurokinin-1 Receptor Antagonist for the Treatment of Pruritus in Patients With Epidermolysis Bullosa

Phase 2

Completed

Conditions: Epidermolysis Bullosa

Interventions: Drug: Placebo Oral Tablet
Drug: Serlopitant Tablet

First Posted Date: 2019-02-11

Last Posted Date: 2023-02-14

Lead Sponsor: Stanford University

Target Recruit Count: 28

Registration Number: NCT03836001

Locations: 🇺🇸
Stanford University, Redwood City, California, United States

Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis

Phase 3

Completed

Conditions: Prurigo Nodularis
Pruritus

Interventions: Drug: Placebo Tablets
Drug: 5mg Serlopitant Tablets

First Posted Date: 2018-09-19

Last Posted Date: 2021-05-20

Lead Sponsor: Vyne Therapeutics Inc.

Target Recruit Count: 295

Registration Number: NCT03677401

Locations: 🇵🇱
Study Site 636, Bydgoszcz, Poland
🇵🇱
Study Site 631, Olsztyn, Poland
🇦🇹
Study Site 649, Graz, Austria

and more 37 locations

Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis

Phase 3

Completed

Conditions: Pruritus
Prurigo Nodularis

Interventions: Drug: Placebo Tablets
Drug: 5mg Serlopitant Tablets

First Posted Date: 2018-06-06

Last Posted Date: 2021-05-20

Lead Sponsor: Vyne Therapeutics Inc.

Target Recruit Count: 285

Registration Number: NCT03546816

Locations: 🇺🇸
Study Site 529, Verona, New Jersey, United States
🇺🇸
Study Site 533, Rogers, Arkansas, United States
🇺🇸
Study Site 501, Aventura, Florida, United States

and more 46 locations

Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)

Phase 3

Terminated

Conditions: Pruritus
Prurigo Nodularis
Atopic Dermatitis
Psoriasis

Interventions: Drug: 5 mg Serlopitant Tablets

First Posted Date: 2018-05-30

Last Posted Date: 2021-05-20

Lead Sponsor: Vyne Therapeutics Inc.

Target Recruit Count: 558

Registration Number: NCT03540160

Locations: 🇺🇸
Study Site 201, East Windsor, New Jersey, United States
🇺🇸
Study Site 523, Philadelphia, Pennsylvania, United States
🇺🇸
Study Site 502, Dallas, Texas, United States

and more 82 locations

Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Plaque Psoriasis

Phase 2

Completed

Conditions: Pruritus
Psoriasis

Interventions: Drug: 5 mg Serlopitant Tablets
Drug: Matching Placebo Tablets

First Posted Date: 2017-11-17

Last Posted Date: 2021-05-20

Lead Sponsor: Vyne Therapeutics Inc.

Target Recruit Count: 204

Registration Number: NCT03343639

Locations: 🇺🇸
Study Site 376, Santa Monica, California, United States
🇺🇸
Study Site 213, Boise, Idaho, United States
🇺🇸
Study Site 207, South Bend, Indiana, United States

and more 36 locations

Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough

Phase 2

Completed

Conditions: Refractory Chronic Cough

Interventions: Drug: 5 mg Serlopitant Tablets
Drug: Matching Placebo Tablets

First Posted Date: 2017-09-14

Last Posted Date: 2021-05-20

Lead Sponsor: Vyne Therapeutics Inc.

Target Recruit Count: 185

Registration Number: NCT03282591

Locations: 🇺🇸
Study Site 122, Cincinnati, Ohio, United States
🇬🇧
Study Site 141, Llanelli, United Kingdom
🇺🇸
Study Site 123, San Diego, California, United States

and more 36 locations

Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury

Phase 2

Terminated

Conditions: Pruritus
Burns

Interventions: Drug: Placebo
Drug: Serlopitant

First Posted Date: 2016-11-29

Last Posted Date: 2021-05-20

Lead Sponsor: Vyne Therapeutics Inc.

Target Recruit Count: 1

Registration Number: NCT02975271

Locations: 🇺🇸
Study Site 409, Lincoln, Nebraska, United States
🇺🇸
Study Site 403, Tampa, Florida, United States
🇺🇸
Study Site 413, Seattle, Washington, United States

and more 4 locations

Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis

Phase 2

Completed

Conditions: Pruritus
Atopic Dermatitis

Interventions: Drug: Placebo Oral Tablet
Drug: Serlopitant High Dose
Drug: Serlopitant Low Dose

First Posted Date: 2016-11-29

Last Posted Date: 2021-05-20

Lead Sponsor: Vyne Therapeutics Inc.

Target Recruit Count: 484

Registration Number: NCT02975206

Locations: 🇺🇸
Study Site 364, Glendale, Arizona, United States
🇺🇸
Study Site 352, Berlin, New Jersey, United States
🇺🇸
Study Site 366, Fountain Valley, California, United States

and more 49 locations

Neurokinin-1 Receptor Antagonist for the Treatment of Itch in EB Patients

Phase 2

Completed

Conditions: Epidermolysis Bullosa
Pruritus

Interventions: Drug: VPD-737
Other: Placebo

First Posted Date: 2016-01-13

Last Posted Date: 2020-03-23

Lead Sponsor: Jean Yuh Tang

Target Recruit Count: 14

Registration Number: NCT02654483

Locations: 🇺🇸
Stanford, Stanford, California, United States

Drug Development Updates

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