Delving into the Latest Updates on ACU-D1 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

ACUD1

Target

26S proteasome

Action

inhibitors

Mechanism

26S proteasome inhibitors(26S proteasome inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesInfectious Diseases+ [3]

Active Indication

Anal intraepithelial neoplasiaHIV InfectionsHuman Papillomavirus Infection+ [1]

Inactive Indication

Rosacea

Originator Organization

Emory University

Active Organization

Emory University

Inactive Organization

Accuitis, Inc.

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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The goal of this study is to test the maximum tolerated dose of ACU-D1 in HIV-positive people with HPV-associated vulvar and perianal lesions. The main questions it aims to answer are:
* The maximum tolerated dose of ACU-D1
* Safety and tolerability of topical ACU-D1
* Whether topical ACU-D1 induces p53 and p53-mediated downstream signaling (including p21 induction) in HPV-related lesions
* Whether topical ACU-D1 enhances markers of immunity in HPV-infected HIV-positive individuals
Participants will be asked
* To apply ACU-D1 on the lesions twice daily for 4 weeks
* 3 biopsies will be performed at the screening and 3 at the end of 4 weeks.

Start Date01 Nov 2025

Sponsor / Collaborator

Emory University

[+1]

NCT03064438

/ CompletedPhase 2

A RANDOMIZED, DOUBLE-BLIND, VEHICLE CONTROLLED, PROOF-OF CONCEPT STUDY OF THE SAFETY AND EFFICACY OF ACU-D1 OINTMENT IN SUBJECTS WITH ACNE ROSACEA

The study evaluated the safety, tolerability, and efficacy of ACCU-D1 when applied twice daily for 12 weeks in adult participants with moderate to severe acne rosacea. Two-third of the participants received ACCU-D1 while one-third of the participants received vehicle control.

Start Date28 Nov 2017

Sponsor / Collaborator

Accuitis, Inc.

100 Clinical Results associated with ACU-D1

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100 Translational Medicine associated with ACU-D1

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100 Patents (Medical) associated with ACU-D1

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2

Literatures (Medical) associated with ACU-D1

01 May 2025·Journal of Drugs in Dermatology

Successful Treatment of Sacral Pressure Injury With ACU-D1

Article

Author: Huang, Christina ; L. Arbiser, Jack

Pressure injuries, previously known as pressure ulcers, commonly affect elderly patients in the sacral area, resulting in a sacral pressure injury. The mainstay of treatment is supportive care, including avoiding further pressure on the wounded area. In our case report, we encountered a patient with a stage 2 pressure injury that was resistant to a month of supportive treatment, with no improvement. After a trial of 10% ACU-D1, a proteasome inhibitor cream, the patient experienced relief in symptoms and complete re-epithelialization of the injury site within one month. With emerging research suggesting a role of inflammation and neutrophil activation in pressure injuries, we propose that further investigation into ACU-D1 for pressure injuries and other chronic wounds could benefit patients. Citation: Huang C, Arbiser JL. Successful treatment of sacral pressure injury with ACU-D1. J Drugs Dermatol. 2025;24(5):534-535. doi:10.36849/JDD.8782.

01 Jun 2021·Journal of drugs in dermatology : JDDQ4 · MEDICINE

Evaluation of a First-in-Class Proteasome Inhibitor in Patients With Moderate to Severe Rosacea.

Q4 · MEDICINE

Article

Author: Jackson, J Mark ; Arbiser, Jack L ; Coulon, Rick

BACKGROUND:

Novel, effective, affordable therapies for rosacea are needed. Innovative methods of assessing response for rosacea treatments are needed as well. This trial was designed to evaluate efficacy and safety of ACU-D1, a novel inhibitor of the 26S protea-some for the treatment of moderate to severe rosacea in a first in human pilot study. In addition, this is the first trial to our knowledge to use Canfield imaging to quantitatively assess responses.

METHODS:

This was a 14-week, randomized, double-blinded, placebo-controlled study, performed at two well established rosacea clini-cal trial sites, which randomized 40 adult subjects with moderate to severe rosacea (Investigator’s Global Assessment [IGA]=3/4) to either ACU-D1 (27) or comparator vehicle (13) twice daily. In addition, Canfield imaging was used to assess responses both qualitatively and quantitatively Results: A total of 39 subjects participated, with 38 completing the study. ACU-D1 displayed efficacy in 92% (25 of 27) of patients in reducing inflammatory lesions and a 2 plus grade IGA reduction of clear to near clear in 27% of patients. There was a trend toward improvement in erythema as well in the active arm.

CONCLUSION:

This study demonstrates that topical ACU-D1 is safe and well-tolerated by patients in the study and demonstrates efficacy in reducing inflammatory lesions and erythema in patients with rosacea. Improvement was also noted on Canfield imaging, and this modality is likely to be used as an objective measure in the future. Further studies are warranted based on these initial positive results. ClinicalTrials.gov Identifier: NCT03064438 J Drugs Dermatol. 2021;20(6):660-664. doi:10.36849/JDD.5925.

100 Deals associated with ACU-D1

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rosacea	Phase 2	United States	Accuitis, Inc.	28 Nov 2017
Anal intraepithelial neoplasia	Phase 1	United States	Emory University	01 Jun 2026
HIV Infections	Phase 1	United States	Emory University	01 Jun 2026
Human Papillomavirus Infection	Phase 1	United States	Emory University	01 Jun 2026
Squamous Intraepithelial Lesions	Phase 1	United States	Emory University	01 Jun 2026

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03064438 (CTgov)	Phase 2	Rosacea	40	ACCU-D1 (ACU-D1 Ointment)	yghztltlal(yeqkiqkhix) = aborlkboqa umpiifkqsa (grzedszgkz, 1.08) View more	-	23 Aug 2021
				Vehicle (ACU-D1 Ointment Vehicle)	yghztltlal(yeqkiqkhix) = fieoiowcur umpiifkqsa (grzedszgkz, 1.62) View more
NCT03064438 (Pubmed \| J Drugs Dermatol) Manual	Phase 2	Rosacea	40	ACU-D1	qggyrqhdiw(tpkarzvosq) = cjfhoukpap vtxsvsnkmb (jernnjhoeh ) View more	Positive	01 Jun 2021
				comparator	-