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AGN-190168

Phase 1

Acne Vulgaris | Small molecule | Dermatology |AbbVie Inc.|Trials Updated: Apr 30, 2015

AGN-190168 target and mechanism

ModalitySmall molecule

Also known as AGN-190168 Formulation 1, AGN-190168 Formulation 2

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

AGN-190168 clinical trials

AGN-190168 · 1 trial · 1 indication

Phase 1 1
NCT02218034Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne VulgarisAcne Vulgaris
COMPLETED78 Analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris
Acne VulgarisUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Plasma Level (Cmax) of AGN-190168
Day 29
Maximum Plasma Level (Cmax) of AGN-190168 Metabolite
Day 29
Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale
Day 29
Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale
Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
AGN-190168 Formulation 1EXPERIMENTALAGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
AGN-190168 Formulation 2EXPERIMENTALAGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
TAZORAC® Gel 0.1%ACTIVE_COMPARATORTAZORAC® Gel 0.1% (tazarotene gel 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
TAZORAC® Cream 0.1%ACTIVE_COMPARATORTAZORAC® Cream 0.1% (tazarotene cream 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.

Interventions

NameTypeDescription
AGN-190168 Formulation 1DRUGAGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
AGN-190168 Formulation 2DRUGAGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
tazarotene gel 0.1%DRUGTazarotene gel 0.1% applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
tazarotene cream 0.1%DRUGTazarotene cream 0.1% cream applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of acne vulgaris on the face * No tobacco use for the past 30 days, and willing to refrain from nicotine use during the study * Willing to avoid excessive or prolonged exposure of the treated skin to ultraviolet light (eg, sunlight, tanning beds) and extremes in weat...

Countries:United States
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Frequently asked questions about AGN-190168

What is AGN-190168?

AGN-190168 is an investigational small molecule being developed by AbbVie Inc. for the treatment of acne vulgaris. It has been studied in a Phase 1 clinical trial evaluating safety, tolerability, and pharmacokinetics in subjects with acne vulgaris. It is not approved and remains in clinical development.

What is AGN-190168 used for?

AGN-190168 is being developed for the treatment of acne vulgaris, a common dermatological condition. Its clinical evaluation has focused on subjects with acne vulgaris, including adolescents as young as 12 years of age. The drug is investigational and has not been approved for any use.

Who makes AGN-190168?

AGN-190168 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the compound in acne vulgaris.

What phase is AGN-190168 in?

AGN-190168 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound is investigational and has not been approved by the FDA for acne vulgaris or any other indication.

What clinical trials is AGN-190168 in?

AGN-190168 has been evaluated in the Phase 1 trial NCT02218034, titled Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris. The trial enrolled 78 participants in the United States, was randomized and active-controlled, and has been completed.

Is AGN-190168 the same as AGN-190168 Formulation 1 or Formulation 2?

Yes. AGN-190168 is also known as AGN-190168 Formulation 1 and AGN-190168 Formulation 2. These names refer to the same investigational compound developed by AbbVie for acne vulgaris, so searches using any of these names point to the same drug asset.