A 24-Month, Randomized, Double-Masked, Placebo-Controlled Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndrome

The goal of this clinical trial is to learn if NPI-001 works to prevent progression of retinitis pigmentosa in adults diagnosed with Usher syndrome. It will also provide information about the safety of NPI-001. The main questions it aims to answer are:
Does NPI-001 slow down the loss of photoreceptors? What medical problems do participants have when taking NPI-001? Researchers will compare NPI-001 to a placebo (a look-alike substance that contains no drug) to see if NPI-001 works to preserve vision.
Participants will:
Take NPI-001 or a placebo twice a day, every day for 24 months Visit the clinic 9 times for checkups and tests

Start Date01 Dec 2026

Sponsor / Collaborator

Nacuity Pharmaceuticals, Inc.

NCT07710196

/ Not yet recruitingPhase 3

A 24-Month, Randomized, Double-Masked, Placebo-Controlled Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis PigmentosaAssociated With Usher Syndrome

Start Date01 Aug 2026

Sponsor / Collaborator

Nacuity Pharmaceuticals, Inc.

[+1]

NCT07634991

/ RecruitingPhase 4IIT

Effect of N-Acetyl Cysteine on Oxidative Stress and Clinical Outcome of Patients With Diabetic Retinopathy

N-acetylcysteine (NAC) emerges as a crucial factor in mitigating oxidative stress and inhibiting vascular endothelial activation in diabetic patients, through its effect on VEGF expression as VEGF is involved in the development of diabetic microvascular complications through the promotion of retinal angiogenesis and increased vascular permeability.
It was reported in the literature that NAC administration was safe in several studies. It was shown that the dose of 1200 mg is safe and effective.
To the best of our knowledge, the present study is the first to be designed to evaluate the effect of N-acetyl cysteine on diabetic retinopathy in type 2 diabetic patients.

Start Date10 Jan 2026

Sponsor / Collaborator

Ain Shams University

100 Clinical Results associated with N-Acetylcysteine amide

100 Translational Medicine associated with N-Acetylcysteine amide

100 Patents (Medical) associated with N-Acetylcysteine amide

243

Literatures (Medical) associated with N-Acetylcysteine amide

17 Feb 2026·ACS Nano

A First-Aid Nanomedicine Endowed with Microenvironment Self-Adaptive Regulation Ability to Facilitate Acute Liver Failure Prophylaxis and Therapy

Article

Author: Yan, Mijia ; Zhang, Qiuhong ; Zhang, Jiale ; Yao, Wenzhan ; Chen, Hangrong ; Liu, Min ; Tang, Yiwen

Acute liver failure (ALF) represents a life-threatening medical emergency with high mortality, yet limited treatment is available clinically. Here, we report albumin-biomineralized nonstoichiometric copper sulfide nanoparticles serving as first-aid nanomedicine to combat ALF, conceptualized as NanoAID. The NanoAID exhibits an electron-donor nanoantioxidant property to scavenge reactive oxygen species and concurrent anti-inflammatory capacity to reprogram pro-inflammatory M1 macrophages into anti-inflammatory M2-phenotype, thereby mitigating excessive oxidative and inflammatory stress in ALF lesions. More interestingly, we found Cu ions release under an in situ oxidative stress switch and the resulting H₂S gas generation by NanoAID degradation, which further enhance the biosynthesis of intrahepatic antioxidant enzyme SOD1 and the repolarization of M1-to-M2 macrophages, respectively, thereby self-reinforcing ALF therapy. Such microenvironment self-adaptive regulation confers NanoAID with effective prophylactic efficacy and significant ALF survival advantages over the FDA-approved N-acetyl cysteine in multiple animal models, extending the first-aid window to 6 h post APAP intoxication. Transcriptomics results reveal the molecular mechanisms of NanoAID by promoting antioxidative and inhibiting inflammatory pathways, underscoring its great potential as a next-generation first-aid nanomedicine for ALF management.

13 Feb 2026·ACS Infectious Diseases

Antifungal Activity of Lipophilic Bisphosphonates

Article

Author: Ong, Zi Ying ; Chen, Yiyuan ; Shah, Rishi ; Adusei-Poku, Serwa ; Li, Fangrong ; Singh, Davinder ; Koo, Jamie ; Le, Annie ; Pandey, Akanksha M. ; He, Mingdi ; Zhou, Ruijie ; Oldfield, Eric ; Rohlwing, Nicholas J. ; Herdrich, Jayannah

We investigated the activity of a series of 75 lipophilic bisphosphonates against Candida glabrata. Thirty-six compounds had MIC < 1 μg/mL, 18 had MIC < 0.5 μg/mL, and 2 had MIC = 0.13 μg/mL, comparable to amphotericin B and caspofungin. The lipophilic bisphosphonates were ∼20-fold more potent against C. glabrata than the most potent hydrophilic bisphosphonate, zoledronate. The most active compounds were pyridinium bisphosphonates followed by imidazolium bisphosphonates, while aryl bisphosphonates were less active. Several compounds had selectivity index values against a human cell line in the 1000-3600 range, the most selective compounds being para-substituted pyridinium bisphosphonates. We also found similar activity against a caspofungin-resistant FKS2 (F659S) mutant. Some combinations of lipophilic bisphosphonates had synergistic activity with FICI values in the ∼0.3-0.5 range, and similar synergies were observed with fluconazole, implicating ergosterol biosynthesis inhibition leading to compromised membrane structure and function. Cell growth inhibition was rescued by ascorbic acid, glutathione, and N-acetyl cysteine, indicating a ROS-based killing mechanism. There was also synergy with other antifungals but very strong antagonism with verapamil (FICI ∼4), which blocks calcium channels. Unlike hydrophilic bisphosphonates, which target farnesyl diphosphate synthase, lipophilic bisphosphonates also target squalene synthase, suggesting that the combination of multitargeting bisphosphonates is one origin of the synergistic interactions observed. Given that one of the lipophilic bisphosphonates studied here (BPH-1237) has been shown to have activity against many other human fungal pathogens, combinations with the compounds described here may be of interest as antifungal leads.

01 Dec 2025·ENVIRONMENTAL TOXICOLOGY AND PHARMACOLOGY

Protective effects of N-acetylcysteine and its amide derivative against toxic metals in vitro: Potential alternatives/adjuncts to traditional chelators

Article

Author: Sawyer, Thomas W ; Song, Yanfeng

The protective efficacies of N-acetylcysteine (NAC) and N-acetylcysteine amide (NACA) against the toxicity of compounds containing arsenic, cadmium, cobalt, chromium and mercury, were compared to those of dimercaprol, dimercaptosuccinic acid, 2,3-dimercaptopropanesulphonate, D-penicillamine, and derivatives of ethylenediamine tetraacetic acid and diethylenetriaminepentaacetic in CHO-K1 cells. Both NAC and NACA were found to confer protection against these metals, with comparable or better efficacy than many of the test chelators. Results from studies using the glutathione synthesis inhibitor buthionine sulphoximine were consistent with NAC/NACA protection being mediated through both GSH up-regulation and chelation. Given NAC's activity against metal toxicity, widespread clinical use, parenteral or oral routes of administration, high clinical safety, low cost and ease of accessibility, it should be given consideration as a broad-spectrum protectant against toxic metal poisoning as a treatment or adjunct/combination treatment. Its more lipophilic derivative NACA, also warrants attention, especially in those cases where brain toxicity is a concern.

News (Medical) associated with N-Acetylcysteine amide

17 Jun 2026

·www.prnewswire.com

A Race Against Blindness Commits $1 Million to Advance Gene-Agnostic Therapeutic Approaches

The commitment directs $775,000 to the RD Fund, to be matched dollar for dollar, and $225,000 to a Foundation Fighting Blindness research award, advancing approaches that can help patients regardless of the gene causing their retinal disease COLUMBIA, Md. and RALEIGH, N.C., June 17, 2026 /PRNewswire/ -- The Foundation Fighting Blindness and its venture arm, the RD Fund (Retinal Degeneration Fund), today announced a $1 million commitment from A Race Against Blindness (RAB) to advance gene-agnostic therapeutic approaches for inherited retinal diseases. The commitment directs $775,000 to the RD Fund and $225,000 to a Foundation Fighting Blindness research award. The $775,000 to the Fund will be matched dollar for dollar through the Gordon and Llura Gund Foundation Challenge, unlocking $1.55 million in impact, a donor match that doubles new and increased gifts to the RD Fund. A Race Against Blindness was founded in 2023 by Dr. Stephen and Kristina Johnston after their son was diagnosed with retinitis pigmentosa (RP) caused by Bardet-Biedl syndrome (BBS). Since then, the family-run nonprofit has directed millions of dollars toward research for RP and BBS, with a focus on pediatric inherited retinal diseases and on moving promising therapies from concept to clinic with urgency. "As parents, we know families cannot wait for a separate therapy to be developed for every one of the thousands of mutations that cause retinitis pigmentosa," said Dr. Stephen Johnston, co-founder of A Race Against Blindness. "Gene-agnostic approaches offer hope to the broadest possible community, including children with Bardet-Biedl syndrome like our son. By directing our support to the RD Fund and to the Foundation's research, and seeing the Fund portion matched, we can put more resources behind the science that reaches the most families the fastest." Advancing Gene-Agnostic Approaches Across the RD Fund Portfolio The $775,000 directed to the RD Fund will support gene-agnostic therapeutic approaches across the Fund's portfolio companies, which are developing treatments designed to help patients regardless of the specific gene mutation causing their disease. The RD Fund intentionally balances its portfolio between gene-specific and gene-agnostic strategies, including neuroprotective and antioxidant approaches that slow disease progression and vision-restoration strategies such as optogenetics, which aims to restore light sensitivity to the retina independent of the underlying gene defect. One example is Nacuity Pharmaceuticals, a clinical-stage portfolio company developing a neuroprotective, gene-agnostic candidate. Nacuity's lead candidate, NPI-001, is an oral tablet formulation of N-acetylcysteine amide that targets oxidative stress, a process that damages photoreceptors across many forms of retinal degeneration. Rather than correcting a single gene, NPI-001 is designed to boost glutathione, one of the body's most powerful natural antioxidants, to help protect retinal cells regardless of the underlying mutation. The U.S. Food and Drug Administration has granted NPI-001 Fast Track, Breakthrough Therapy, and Orphan Drug designations for the treatment of retinitis pigmentosa. "The partnership with A Race Against Blindness reflects the conviction the RD Fund was built to reward," said Rusty Kelley, PhD, managing director of the RD Fund. "Their support matched by the Gordon and Llura Gund Foundation, allows us to diversify and strengthen our portfolio of gene-agnostic approaches that could one day benefit the entire retinitis pigmentosa community, including the RP and BBS1 families represented by A Race Against Blindness." Funding Gene-Agnostic Innovation at the Foundation Fighting Blindness The remaining $225,000 of the commitment will complete funding for a Foundation Fighting Blindness Career Development Award supporting Dr. Thomas Mendel at The Ohio State University Wexner Medical Center in Columbus, Ohio. The five-year, $375,000 award funds research into a new way to deliver retinal gene therapy that could apply across many inherited retinal diseases. Dr. Mendel is testing a surgical approach in preclinical models that delivers gene therapy onto the surface of the retina, rather than beneath it, combined with insulin added to the therapy to accelerate its uptake into retinal cells. The approach aims to deliver therapy faster and with less inflammation, without compromising retinal function. Because the delivery method is gene-agnostic, it has the potential to improve treatment for conditions including Bardet-Biedl syndrome, choroideremia, Leber congenital amaurosis, Stargardt disease, Usher syndrome, and multiple forms of retinitis pigmentosa. Dr. Mendel's work is mentored by Andy J. Fischer, PhD, and Cagri Besirli, MD, PhD. "Some of the most powerful ideas in our field are the broad-reaching ones that can help many patients across the spectrum of inherited retinal diseases," said Amy Laster, PhD, chief scientific officer of the Foundation Fighting Blindness. "Whether through the RD Fund's portfolio or a Foundation-supported researcher like Dr. Mendel, this commitment from A Race Against Blindness accelerates approaches that do not depend on a single gene, and that gives hope to families across the entire community." As the world's leading private funder of retinal degenerative disease research, the Foundation Fighting Blindness has played a key role in driving the development of more than 60 retinal disease drug candidates now in clinical trials, a track record that made it a natural partner for A Race Against Blindness. About A Race Against Blindness A Race Against Blindness is a family-run nonprofit co-founded in 2023 by Dr. Stephen and Kristina Johnston after their son was diagnosed with retinitis pigmentosa caused by Bardet-Biedl syndrome. Through innovative fundraising and a focus on pediatric inherited retinal diseases, the organization has directed more than $5 million toward research for retinitis pigmentosa and Bardet-Biedl syndrome, working to move promising therapies from concept to clinic with urgency. For more information, visit araceagainstblindness.org. About the Foundation Fighting Blindness Established in 1971, the Foundation Fighting Blindness is the world's leading private funding source for retinal degenerative disease research. The Foundation has raised nearly $1 billion toward its mission of accelerating research for preventing, treating, and curing blindness caused by the entire spectrum of retinal degenerative diseases, including retinitis pigmentosa, age-related macular degeneration, Usher syndrome, and Stargardt disease. Visit FightingBlindness.org for more information. About the RD Fund The Retinal Degeneration Fund (RD Fund) is a mission-driven venture fund established by the Foundation Fighting Blindness to invest in companies developing innovative therapies for inherited retinal diseases and dry age-related macular degeneration. The RD Fund was designed to bridge the funding gap between discovery research and confirmatory clinical trials. For more information, visit . Media Contact: Chris Adams Foundation Fighting Blindness 410-423-0585 [email protected] SOURCE Foundation Fighting Blindness 21% more press release views with Request a Demo

Orphan DrugFast TrackBreakthrough Therapy

03 Nov 2025

·www.prnewswire.com

Arctic Therapeutics Receives EMA Approval for Phase IIa Study of AT-001 in Alzheimer's Disease

The European Medicines Agency (EMA) authorises initiation of a Phase IIa study evaluating AT-001 in patients diagnosed with Alzheimer's disease EMA grants Orphan Drug Designation (ODD) to AT-001 for hereditary cystatin C amyloid angiopathy (HCCAA), a rare familial dementia REYKJAVÍK, Iceland, Nov. 3, 2025 /PRNewswire/ -- Arctic Therapeutics (ATx), an Iceland-based clinical-stage biopharmaceutical company, today announced key regulatory milestones for its lead investigational therapy, AT-001, which is in development for both rare and common forms of dementia. ATx has initiated a Phase IIa clinical trial to evaluate the safety and biomarker-based efficacy of AT-001 in individuals with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (AD). The multicentre, randomized, double-blind, placebo-controlled, dose-escalation study will assess the safety profile of AT-001, as well as its impact on novel blood-based biomarkers and brain amyloid deposition. "Alzheimer's disease is one of the world's most urgent healthcare challenges. Advances in early diagnosis , combined with treatments that enable earlier intervention , hold the potential to transform how we approach Alzheimer's, as well as other forms of dementia," ATx founder Dr. Hakon Hakonarson said. "Through our clinical trials targeting both rare and common forms of dementia, we are pushing the science forward with the goal of not only delaying progression, but ultimately preventing these diseases altogether," Dr. Hakonarson added. The study authorisation in AD follows the EMA's authorisation last year for ATx to initiate a Phase IIb/III study of AT-001 in HCCAA, an ultra-rare condition marked by amyloid buildup in the brain's blood vessels that can cause cerebral haemorrhage, stroke and progressive neurological decline, including dementia. In addition, the EMA has granted AT-001 ODD for the treatment of HCCAA, a form of hereditary cerebral amyloid angiopathy (CAA). "The ODD status confirms the ground-breaking nature of AT-001 as a potentially disease-modifying treatment for HCCAA and underpins our expansion into other forms of dementia, including Alzheimer's," CEO and co-founder Ivar Hakonarson said. "This is a significant milestone and underscores the urgent unmet medical need in HCCAA and provides ATx with an important regulatory milestone to advance AT-001 in this rare and devastating condition." About the Phase IIa Study The study will evaluate the safety, tolerability, and biomarker-based efficacy of AT-001, a small molecule oral therapy, in patients aged 50-85 with mild cognitive impairment (MCI) or mild Alzheimer's disease. The study will be a multicentre, randomized, double-blind, placebo-controlled trial conducted at four sites across Denmark and Iceland in collaboration with Sanos Group, a global multi-niche CRO. The trial will enrol patients for 12 months of treatment with escalating oral doses of AT-001. Safety labs will be monitored monthly, together with biomarker assessments every three months, MRI at baseline, mid- and end of study, and PET scans at baseline and study completion. Endpoints and Biomarkers The study's primary focus is on safety and biomarker efficacy. Selected biomarkers include: Plasma pTau217 and total Tau - measured with Quanterix Simoa® technology to track early tau pathology and neuronal damage. Neurofilament Light Chain (NfL) - a marker of axonal injury and neurodegeneration. Toxic amyloid-β oligomers - measured with the novel SOBA assay to detect synaptotoxic species driving memory loss. Imaging MRI - to evaluate brain atrophy and white matter integrity. PET scans - to visualize amyloid plaque burden and assess potential reductions with AT-001. Upon completion of the trial the biomarker/brain amyloid results will be analysed in the context of clinical improvement observed with recent monoclonal antibody-based amyloid reduction therapies. About Arctic Therapeutics Arctic Therapeutics is an Icelandic drug discovery and development company established in 2015 as a spin-off from the US-based Center for Applied Genomics (CAG), a research centre at the Children's Hospital of Philadelphia. ATx leverages the transformative power of applied genomics, steering the course of drug development towards safer, more effective treatments for some of the world's most challenging diseases. The company has operations in Iceland, the US and multiple collaborations across Europe. For more information, please visit: and follow us on LinkedIn . For media inquires Gulli Arnason, Chief Strategy Officer [email protected] +354 660 0053 This information was brought to you by Cision . The following files are available for download: 21% more press release views with Request a Demo

Phase 2Orphan Drug

03 Nov 2025

·www.arctictherapeutics.com

Arctic Therapeutics Receives EMA Approval for Phase IIa Study of AT-001 in Alzheimer’s Disease

The European Medicines Agency (EMA) authorises initiation of a Phase IIa study evaluating AT-001 in patients diagnosed with Alzheimer’s disease EMA grants Orphan Drug Designation (ODD) to AT-001 for hereditary cystatin C amyloid angiopathy (HCCAA), a rare familial dementia REYKJAVIK, ICELAND – November 3, 2025 – Arctic Therapeutics (ATx), an Iceland-based clinical-stage biopharmaceutical company, today announced key regulatory milestones for its lead investigational therapy, AT-001, which is in development for both rare and common forms of dementia. ATx has initiated a Phase IIa clinical trial to evaluate the safety and biomarker-based efficacy of AT-001 in individuals with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease (AD). The multicentre, randomized, double-blind, placebo-controlled, dose-escalation study will assess the safety profile of AT-001, as well as its impact on novel blood-based biomarkers and brain amyloid deposition. “Alzheimer’s disease is one of the world’s most urgent healthcare challenges. Advances in early diagnosis, combined with treatments that enable earlier intervention, hold the potential to transform how we approach Alzheimer’s, as well as other forms of dementia,” ATx founder Dr. Hakon Hakonarson said. “Through our clinical trials targeting both rare and common forms of dementia, we are pushing the science forward with the goal of not only delaying progression, but ultimately preventing these diseases altogether,” Dr. Hakonarson added. The study authorisation in AD follows the EMA’s authorisation last year for ATx to initiate a Phase IIb/III study of AT-001 in HCCAA, an ultra-rare condition marked by amyloid buildup in the brain’s blood vessels that can cause cerebral haemorrhage, stroke and progressive neurological decline, including dementia. In addition, the EMA has granted AT-001 ODD for the treatment of HCCAA, a form of hereditary cerebral amyloid angiopathy (CAA). “The ODD status confirms the ground-breaking nature of AT-001 as a potentially disease-modifying treatment for HCCAA and underpins our expansion into other forms of dementia, including Alzheimer’s,” CEO and co-founder Ivar Hakonarson said. “This is a significant milestone and underscores the urgent unmet medical need in HCCAA and provides ATx with an important regulatory milestone to advance AT-001 in this rare and devastating condition.” About the Phase IIa Study The study will evaluate the safety, tolerability, and biomarker-based efficacy of AT-001, a small molecule oral therapy, in patients aged 50–85 with mild cognitive impairment (MCI) or mild Alzheimer’s disease. The study will be a multicentre, randomized, double-blind, placebo-controlled trial conducted at four sites across Denmark and Iceland in collaboration with Sanos Group, a global multi-niche CRO. The trial will enrol patients for 12 months of treatment with escalating oral doses of AT-001. Safety labs will be monitored monthly, together with biomarker assessments every three months, MRI at baseline, mid- and end of study, and PET scans at baseline and study completion. Endpoints and Biomarkers The study’s primary focus is on safety and biomarker efficacy. Selected biomarkers include: Plasma pTau217 and total Tau — measured with Quanterix Simoa® technology to track early tau pathology and neuronal damage. Neurofilament Light Chain (NfL) — a marker of axonal injury and neurodegeneration. Toxic amyloid-β oligomers — measured with the novel SOBA assay to detect synaptotoxic species driving memory loss. Imaging MRI — to evaluate brain atrophy and white matter integrity. PET scans — to visualize amyloid plaque burden and assess potential reductions with AT-001. Upon completion of the trial the biomarker/brain amyloid results will be analysed in the context of clinical improvement observed with recent monoclonal antibody-based amyloid reduction therapies. About Arctic Therapeutics Arctic Therapeutics is an Icelandic drug discovery and development company established in 2015 as a spin-off from the US-based Center for Applied Genomics (CAG), a research centre at the Children’s Hospital of Philadelphia. ATx leverages the transformative power of applied genomics, steering the course of drug development towards safer, more effective treatments for some of the world’s most challenging diseases. The company has operations in Iceland, the US and multiple collaborations across Europe.

Phase 2Orphan Drug

100 Deals associated with N-Acetylcysteine amide

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14480

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Usher Syndromes	Phase 3	-	Nacuity Pharmaceuticals, Inc.	01 Aug 2026
Mild cognitive disorder	Phase 2	Denmark	Arctic Therapeutics	14 Oct 2025
Mild cognitive disorder	Phase 2	Iceland	Arctic Therapeutics	14 Oct 2025
Alzheimer Disease	Phase 2	Denmark	Arctic Therapeutics	14 Oct 2025
Alzheimer Disease	Phase 2	Iceland	Arctic Therapeutics	14 Oct 2025
Cerebral Amyloid Angiopathy, Familial	Phase 2	Iceland	Arctic Therapeutics	03 Apr 2024
Cystinosis	Phase 2	Australia	Nacuity Pharmaceuticals, Inc.	29 Oct 2023
Cerebral Amyloid Angiopathy	Phase 2	United States	Arctic Therapeutics	-
Colorectal Cancer	Preclinical	United States	University of Florida College of Medicine	19 Dec 2025
Non-Small Cell Lung Cancer	Preclinical	United States	University of Florida College of Medicine	19 Dec 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04632069 (CTgov)	Early Phase 1	Pregnancy in Diabetics \| Diabetes Mellitus \| stress oxidative	10	N acetyl cysteine + vagus nerve stimulation	jscqpzxkft(oildvadhza) = qvowvfwjud uubdwbsihj (fbjikxjhba, 0.4) View more	-	29 Aug 2024
NCT01251315 (CTgov)	Phase 1	stress oxidative	24	Placebo (Placebo-A)	itnkdoxtlf(yjxnigxgbk) = mppaylgheu nwjsqapkca (yuanjugjbk, 133.7) View more	-	17 Mar 2014
NCT01251315 (CTgov)	Phase 1	stress oxidative	24	N Acetyl cysteine (N Acetyl Cysteine-A)	itnkdoxtlf(yjxnigxgbk) = ftgurpidsz nwjsqapkca (yuanjugjbk, 131.2) View more	-	17 Mar 2014
NCT00332605 (CTgov)	Phase 2	Methamphetamine dependence	45	Placebo	boeslueluu(bipxcpdlsd) = wkglhzttss ruhimqklik (ibksovncln, 6.9) View more	-	24 Jul 2013

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