A Phase 1a/1b Trial in Relapsed/Refractory Small Cell Lung Cancer to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension (12.5 mg/mL) for Intravenous Infusion

This study evaluates a fenretinide phospholipid suspension for the treatment of small cell lung cancer (SCLC).

Start Date01 Jun 2025

Sponsor / Collaborator-

NCT04234048

/ RecruitingPhase 1

A Phase 1a/1b Trial in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension (12.5 Mg/mL) for Intravenous Infusion

This study evaluates a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).

Start Date18 Dec 2023

Sponsor / Collaborator-

NCT06181760

/ CompletedPhase 1

A Phase 1a, Randomized, Double-blind Placebo-controlled Study to Evaluate Safety and Tolerability and to Characterize the Pharmacokinetic Profile of Single Ascending Doses of Fenretinide Oral Capsules in Healthy Adult Volunteers

The goal of this clinical trial was to learn about a single dose of fenretinide in healthy volunteers, in both a fasted and fed state. The main questions to answer were:
* How well is a single dose of fenretinide tolerated? AND
* How is a single dose of fenretinide metabolized in healthy volunteers?
Participants will be asked to:
* Remain confined in a clinical research unit for 5 days after dosing.
* Provide blood samples for intense PK sampling and safety labs.
* Fast for 10 hours prior to administration of study drug (fasted cohorts).
* Consume a high fat meal prior to administration of study drug (fed cohort).
* Return to the clinic for a single follow-up visit for safety assessments.
The study will compare active fenretinide to placebo to see if fenretinide is more or less tolerable than placebo.

Start Date22 Nov 2023

Sponsor / Collaborator

Island Pharmaceuticals Ltd.

100 Clinical Results associated with Fenretinide

100 Translational Medicine associated with Fenretinide

100 Patents (Medical) associated with Fenretinide

1,515

Literatures (Medical) associated with Fenretinide

01 Mar 2025·Journal of Cosmetic Dermatology

A Functional Skincare Formulation Mixed With Retinyl Propionate, Hydroxypinacolone Retinoate, and Vitamin C on Antiaging and Whitening Han Women in Shanghai, China

Article

Author: Qiao, Jian ; Chen, Min ; Bian, Qianjin ; Zhang, Fan ; Fang, Wei

ABSTRACT:

Background:

Human skin is remodeled as a result of aging. Retinoids (or retinol derivatives) can intervene in this process, which can be optimally formulated and concentrated by providing maximum antiaging effects with minimal irritation.

Aims:

To determine the optimal ratio of two retinol derivatives hydroxypinacolone retinoate (HPR), retinol propionate (RP), and vitamin C (VitC) in dermal remodeling and preventing skin aging, and to investigate their synergistic antiaging and whitening effects in vitro and in vivo.

Methods:

An in vitro model of human skin fibroblast (HSF) was established to evaluate the cellular viability of VitC and/or RP/HPR treatment. We quantified the expression of genes associated with antiaging and retinol receptors in HSFs treated with VitC and/or RP/HPR. The research was conducted on 120 volunteer women to quantify the antiaging efficacy of functional skincare formulation.

Results:

A combination of VitC and RP/HPR at a weight ratio of 40:3 achieved the optimal and safe antiaging performance in vitro. Transcription of aging‐associated genes and the release of elastin and senescence‐associated secretory phenotypes (SASPs) increased significantly after UV irradiation, whereas VitC and RP/HPR cotreatment can inhibit this increase. The synergistic stimulation of VitC and RP/HPR cotreatment showed higher efficacy in the recovery ability of skin injury.

Conclusions:

Our results indicated the advanced skin antiaging and whitening effects of VitC and RP/HPR cotreatment in vitro and in vivo. A combination of VitC and RP/HPR is a potent strategy to postpone skin aging and improve skin whitening for middle‐aged women.

Trial Registration:

ClinicalTrials.gov identifier: 2020‐LS‐023

EXPERIMENTAL PHYSIOLOGY

Hydroxysteroid 17β‐dehydrogenase 13 (Hsd17b13) knockdown attenuates liver steatosis in high‐fat diet obese mice

Article

Author: Morrice, Nicola ; Mahmood, Shehroz ; Mody, Nimesh ; Milanizadeh, Sara ; Mcilroy, George D. ; Thompson, Dawn ; Rochford, Justin J. ; Whitfield, Philip D. ; Wilson, Sophie

Abstract:

Hydroxysteroid 17β‐dehydrogenase 13 (HSD17B13) loss‐of‐function gene variants are associated with a decreased risk of metabolic dysfunction‐associated steatotic liver disease (MASLD). Our RNA‐seq analysis of steatotic liver from obese mice ± fenretinide treatment identified major beneficial effects of fenretinide on expression of hepatic genes including Hsd17b13. We sought to determine the relationship between Hsd17b13 expression and MASLD and to validate it as a therapeutic target by liver‐specific knockdown. Hsd17b13 expression, which is unique to hepatocytes and associated with the lipid droplet, was elevated in multiple models of MASLD and normalised with the prevention of obesity and steatotic liver. Direct, liver‐specific, shRNA‐mediated knockdown of Hsd17b13 (shHsd17b13) in high‐fat diet (HFD)‐obese mice, markedly improved hepatic steatosis with no effect on body weight, adiposity or glycaemia. shHsd17b13 decreased elevated serum alanine aminotransferase (ALT), serum fibroblast growth factor 21 (FGF21) levels, and markers of liver fibrosis, for example, expression of Timp2. shHsd17b13 knockdown in HFD‐obese mice and Hsd17b13 overexpression in cells reciprocally regulated expression of lipid metabolism genes, for example, Cd36. Global lipidomic analysis of liver tissue revealed a major decrease in diacylglycerols (e.g. DAG 34:3) with shHsd17b13 expression and an increase in phosphatidylcholines containing polyunsaturated fatty acids (PUFA) for example, phosphatidylcholine (PC) 34:3 and PC 42:10. Expression of key genes involved in phospholipid and PUFA metabolism, for example, Cept1, was also reciprocally regulated suggesting a potential mechanism of Hsd17b13 biological function and role in MASLD. In conclusion, Hsd17b13 knockdown in HFD‐obese adult mice was able to alleviate MASLD via regulation of fatty acid and phospholipid metabolism, thereby confirming HSD17B13 as a genuine therapeutic target for MASLD and the development of liver fibrosis.

01 Jan 2025·Journal of Cystic Fibrosis

Efficacy and safety of LAU-7b in a Phase 2 trial in adults with cystic fibrosis

Article

Author: Zuckerman, Jonathan B ; Colin, Patrick ; Konstan, Michael W ; Kianicka, Irenej ; Middleton, Peter G ; Kotsimbos, Tom ; Radzioch, Danuta ; Polineni, Deepika ; Matouk, Elias ; Lands, Larry C ; Houle, Jean-Marie ; Liou, Theodore G ; Chmiel, James F ; Potvin, Diane ; Pislariu, Radu ; Bilodeau, Lara ; Nasr, Samya Z

BACKGROUND:

Lung inflammation is associated with tissue damage in cystic fibrosis (CF). LAU-7b, a novel oral drug candidate, was shown to control inflammation and stabilize CFTR protein in the epithelial membrane during inflammatory stress in preclinical models of CF.

METHODS:

A double-blind, randomized, placebo-controlled Phase 2 study was conducted to evaluate efficacy and safety of LAU-7b in adults with CF. LAU-7b or placebo was administered over 24 weeks as six 21-day treatment cycles each separated by 7 days. The primary efficacy endpoint was the absolute change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV₁) at 24 weeks.

RESULTS:

A total of 166 subjects received at least one dose of study drug (Intent-To-Treat population, ITT), of which 122 received ≥5 treatment cycles (Per-Protocol population, PP). Both treatment arms showed a mean lung function loss at 24 weeks of 1.18 ppFEV₁ points with LAU-7b and 1.95 ppFEV₁ with placebo, a 0.77 ppFEV₁ (40 s) difference, p=0.345, and a 0.95 ppFEV₁ (49 %) difference in the same direction in PP population, p=0.263. Primary analysis of mean ppFEV₁ through 24 weeks showed differences of 1.01 and 1.23 ppFEV₁, in the ITT (65 % less loss, p=0.067) and PP populations (78 % less loss, reaching statistical significance p=0.049), respectively. LAU-7b had an acceptable safety profile.

CONCLUSION:

Although the study did not meet its primary efficacy endpoint in the ITT population, LAU-7b was generally well tolerated and showed evidence of preservation of lung function to support further development.

News (Medical) associated with Fenretinide

08 Apr 2025

·www.prnewswire.com

SciTech Development Announces 2nd FDA Approval of a Phase 1 a/b IND For ST-001. New IND Targets the Treatment of Relapsed/Refractory Small Cell Lung Cancer Following Its Previous Approval in the Treatment of T-Cell NHL

GROSSE POINTE FARMS, Mich., April 8, 2025 /PRNewswire/ -- SciTech Development, Inc., a clinical-stage oncology company pioneering innovative cancer therapeutics, is thrilled to announce that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for "A Phase 1a/b Trial in Relapsed/Refractory Small Cell Lung Cancer (SCLC) to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension for Intravenous Infusion." This milestone greenlights SciTech to begin recruiting patients and initiates another Phase 1a/b clinical trial of ST-001, a novel nanoparticle drug designed to deliver fenretinide effectively to cancer cells. The FDA's approval follows a thorough safety review, with the agency stating, "We have completed our safety review of your application and have concluded that you may proceed with your proposed clinical investigation of fenretinide phospholipid suspension (ST-001) for small cell lung cancer." This decision marks a significant step forward in SciTech's mission to address unmet needs in oncology, particularly for patients with relapsed or refractory SCLC, a notoriously aggressive disease with limited treatment options. Leading the trial, as Principal Investigator, is Greg Kalemkerian, MD, a renowned thoracic oncologist at the University of Michigan. "Small cell lung cancer remains a formidable challenge with few effective therapies for patients who relapse or don't respond to initial treatment," said Dr. Kalemkerian. "ST-001 represents a promising approach, and I'm excited to oversee this trial to evaluate its safety and potential for SCLC patients who desperately need new options." ST-001 nanoFenretinide leverages SciTech's patented drug delivery platform to overcome fenretinide's historical bioavailability challenges, delivering high doses intravenously with enhanced efficacy and reduced toxicity. The Phase 1a/b trial will assess the drug's safety, pharmacology, and maximum tolerated dose, paving the way for further development in SCLC and potentially other cancers. Building on prior success in a Phase 1a trial for T-cell non-Hodgkin lymphoma - where ST-001 demonstrated favorable pharmacokinetics and early signs of efficacy - SciTech is preparing to launch the SCLC trial in Q2/3 2025. The company anticipates that this trial will further validate the drug's broad therapeutic potential. "We are thrilled about the FDA's approval of our IND for ST-001 in SCLC," said Earle T. Holsapple, CEO of SciTech Development. "This is a pivotal moment that brings us closer to offering a transformative treatment option for patients facing this devastating disease. "Our team's dedication to advancing ST-001's potential through innovative nanotechnology is showing promising results, and we're eager to see its impact in the clinic." About SciTech Development, Inc. SciTech Development, Inc., headquartered in Grosse Pointe Farms, Michigan, is a clinical-stage pharmaceutical company focused on revolutionizing cancer treatment through its proprietary drug delivery platform. ST-001 nanoFenretinide, its lead candidate, combines fenretinide with biocompatible phospholipids to target hard-to-treat cancers, offering hope to patients worldwide. For more information, please visit or contact: Media Contact: David Schaffer | +1-727-278-8188 | [email protected] Disclaimer: This press release contains forward-looking statements based on current expectations. Actual results may differ due to risks and uncertainties. SciTech undertakes no obligation to update these statements beyond legal requirements. SOURCE SciTech Development, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1IND

13 Jan 2025

·www.prnewswire.com

SciTech Development Advances to Next Stage of Clinical Trial for ST-001 nanoFenretinide

**Encouraging Data from Accelerated Trial Supports Progress for T-cell Non-Hodgkin Lymphoma.** DETROIT, Jan. 13, 2025 /PRNewswire/ -- SciTech Development, a clinical-stage pharmaceutical company specializing in oncology, is pleased to announce the initiation of the next stage of its clinical trial for their lead drug candidate, ST-001 nanoFenretinide (ST-001) . This milestone follows the successful completion of the accelerated safety and dose-escalation stage, where ST-001 demonstrated exceptional safety, tolerability, and pharmacokinetic performance. Advancing the Phase 1a Trial with Clear Clinical Objectives The continuation of the ST-001 clinical trial aims to achieve several critical clinical objectives: Confirm that ST-001 achieves previously reported clinical response rates. Determine the pharmacological profile of intravenous fenretinide delivered using SciTech's novel nanoparticle delivery system, designed for drugs with poor water solubility. Determine the recommended treatment dose (RTD) to evaluate disease activity and response rates in the follow-on Phase 1b trial and the planned trial in Small Cell Lung Cancer. "The success of our accelerated Phase 1a trial marks a pivotal milestone, driving ST-001 into the next critical stage of development," said Earle Holsapple, CEO of SciTech Development. "We are thrilled about the potential of ST-001 nanoFenretinide and its promise to transform treatment outcomes for patients battling cancers such as T-cell Non-Hodgkin Lymphoma." About ST-001 nanoFenretinide ST-001 nanoFenretinide is a patented nanoparticle IV formulation that combines the drug fenretinide with biocompatible phospholipids. This groundbreaking new investigational drug overcomes bioavailability challenges, enhances therapeutic efficacy, and minimizes toxicity in cancer patients. Powered by SciTech's advanced delivery platform, ST-001 enables rapid delivery of effective doses of fenretinide to cancer cells, marking a breakthrough in hard-to-treat cancers. Encouraging Early Results in Phase 1a Accelerated Trial During the accelerated stage of the trial, ST-001 achieved significant milestones: Patient Enrollment is Complete for the accelerated stage of the clinical trial marking a significant accomplishment for patients with this rare disease. Therapeutic Responses Observed: Patients demonstrated partial responses and stable disease, marking an important step for trial advancement. Excellent Tolerability for ST-001 across all dose levels to date. Outstanding Pharmacokinetics: The nanoparticle delivery platform overcame longstanding bioavailability challenges, ensuring efficient delivery of fenretinide to tissues. Future Direction for ST-001 nanoFenretinide Building on the success of the accelerated Phase 1a stage, the trial begins detailed evaluation of clinical activity and response rates in T-cell lymphomas. The trial is actively underway at nine renowned medical centers across the country. Click here to learn more about the locations and patient trial criteria. Additionally, a separate trial targeting Small Cell Lung Cancer utilizing ST-001 is scheduled to begin in Q2 2025. About SciTech Development, Inc. SciTech Development, Inc., headquartered in Michigan, is an oncology focused, clinical-stage pharmaceutical company led by a world-class team. SciTech is committed to developing innovative, effective, and affordable cancer therapeutics that address unmet medical needs to bring hope to patients around the globe. To learn about SciTech and our latest advancements, please visit . Read the latest Press Release announcing "Promising Preliminary Results from the Phase 1a Accelerated Trial". Company Contact: David Schaffer Investor Relations [email protected] (727) 278-8118 SOURCE SciTech Development, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1

19 Dec 2024

·www.prnewswire.com

A Success Story: Digital Opinion Leader Analysis for Cystic Fibrosis Treatments | DelveInsight

A case study on how a pharmaceutical company specializing in cystic fibrosis treatments turned to DelveInsight for comprehensive analysis and insights into the digital cystic fibrosis landscape in the UK. DelveInsight identified key Digital Opinion Leaders (DOLs) and synthesized their opinions, enabling the client to strategically leverage these insights for drug development, marketing, and patient advocacy, ensuring a competitive edge in the cystic fibrosis market. LAS VEGAS, Dec. 19, 2024 /PRNewswire/ -- DelveInsight, a leader in healthcare competitive intelligence and consulting company, published a success study on Digital Opinion Leader (DOL) Analysis in the Cystic Fibrosis Market . A pharmaceutical company specializing in cystic fibrosis treatments approached DelveInsight to conduct an in-depth analysis of DOLs in the UK. The client sought to identify key digital influencers and understand their perspectives on cystic fibrosis treatments, leveraging these insights to inform drug development, marketing strategies, and patient advocacy efforts. Cystic fibrosis is a life-limiting autosomal recessive genetic disorder that primarily affects the lungs and digestive system, caused by mutations in the CFTR gene. According to DelveInsight's latest Cystic Fibrosis Market and Epidem Forecast Report, the estimated total diagnosed prevalent cases of cystic fibrosis in the 7MM in 2023 were ~68K cases. The UK had the highest number of diagnosed cystic fibrosis cases, with nearly 11K, followed by France with 7.5K and Germany with 7K. In the EU4 and the UK, the cystic fibrosis market size was nearly USD 7 billion, accounting for almost 39.4% of the total 7MM market size in 2023. This is expected to increase significantly by 2034. Download the Sample Report to Explore Future Trends in the Cystic Fibrosis Market In the field of cystic fibrosis, DOLs play a significant role in shaping perceptions and influencing the direction of treatment, policy, and patient care. These are influential healthcare professionals or researchers who have an active online presence and contribute to discussions, research, and advocacy. For pharmaceutical companies developing cystic fibrosis treatments, understanding the DOL landscape is crucial for gaining insights into market dynamics and stakeholder perceptions and identifying strategic opportunities for drug development, marketing, and patient advocacy. Several medications have been approved to manage cystic fibrosis, with therapies targeting the CFTR protein to correct its defects. One of the most groundbreaking treatments is TRIKAFTA, a combination of elexacaftor, tezacaftor, and ivacaftor, which has revolutionized cystic fibrosis treatment by improving lung function in patients with specific genetic mutations. Other notable drugs include SYMDEKO (tezacaftor/ivacaftor) and ORKAMBI (lumacaftor/ivacaftor), which also target the CFTR protein. These therapies aim to address the root cause of the disease, improving symptoms and quality of life for patients. However, despite these advancements, the current treatment landscape still faces challenges, such as variability in treatment efficacy and accessibility to newer therapies for certain patient populations. The pipeline for cystic fibrosis treatments continues to evolve, with several promising drugs in the cystic fibrosis pipeline. Ensifentrine (Verona Pharmaceuticals) is a dual inhibitor of the enzymes responsible for inflammation and mucus production in the lungs, showing potential as an add-on therapy for patients with CF. VX-121/TEZ/VX-561 (Vertex Pharmaceuticals) is another exciting treatment, combining triple therapy to enhance CFTR function and improve lung function. LAU-7b (Laurent Pharmaceuticals Inc.) aims to restore CFTR function and reduce inflammation. Lonodelestat (Pari Pharma GmbH) is being investigated for its ability to reduce neutrophil elastase and inflammation in the lungs of CF patients. These drugs, if successful, could significantly improve treatment options and outcomes for CF patients. Several companies are at the forefront of developing treatments for cystic fibrosis. Eloxx Pharmaceuticals, Inc. focuses on treatments that aim to restore protein function in CF patients with specific genetic mutations. Vertex Pharmaceuticals is a leader in the CF market, with therapies like TRIKAFTA and ongoing pipeline developments. Santhera Pharmaceuticals is exploring potential treatments to address pulmonary issues in CF patients. DelveInsight helped the client by curating insights from the digital cystic fibrosis landscape and analyzing the opinions of key digital influencers. By identifying and analyzing these DOLs, DelveInsight provided actionable insights and strategic recommendations for the client. The company gained a deeper understanding of the market dynamics, stakeholder perceptions, and the evolving digital landscape surrounding cystic fibrosis. These insights were invaluable for informing drug development strategies, understanding the gaps, patient burden,, and patient advocacy initiatives. Armed with comprehensive information on DOLs and their impact, the client was better equipped to make informed decisions, enhance patient engagement, and improve the overall market approach for cystic fibrosis treatments. Our client approached us with multiple objectives: Understand the DOL Landscape in the UK for cystic fibrosis. Identify Key Digital Opinion Leaders influencing discussions about cystic fibrosis. Analyze the Opinions of DOLs on treatment options and emerging therapies. Leverage Insights to refine drug development, marketing strategies, and patient advocacy efforts. Outcome of DelveInsight's Digital Opinion Leader Analysis: We identified and profiled key digital opinion leaders (DOLs) in the UK cystic fibrosis community, focusing on those with strong online presence, high engagement, and CF expertise. Through content analysis, we gained insights into opinions, trends, and key areas like treatment, patient care, advocacy, and research within the CF community. We mapped the CF digital ecosystem, highlighting connections and interactions between DOLs and stakeholders revealing network dynamics and engagement patterns. We assessed the impact of DOLs using metrics like follower count, engagement rate, and content virality, helping clients prioritize engagement strategies and collaborations. DelveInsight specializes in comprehensive Key Opinion Leader (KOL) and Digital Opinion Leader (DOL) opinion analysis, offering deep insights into industry trends, expert perspectives, and influencer dynamics. Our expertise enables clients to identify and understand the nerve of the trends by providing analysis through the most impactful thought leaders and digital influencers. By leveraging our tailored strategies and data-driven approaches, we help businesses strengthen their approach, refine decision-making, and amplify their market impact. Connect with us today to explore how we can support your specific needs and discuss opportunities for strategic engagement. Request a Proposal Now ! Why Choose DelveInsight? DelveInsight offers comprehensive expertise in the respiratory disease domain, providing in-depth market research, consulting services, and pipeline analysis tailored to the evolving needs of the industry. With a sharp focus on respiratory conditions, DelveInsight delivers robust reports covering emerging therapies, market trends, competitive landscapes, and unmet needs. DelveInsight's respiratory-specific solutions empower stakeholders to make data-driven decisions, optimize their R&D efforts, and seize growth opportunities in the dynamic and rapidly advancing respiratory disease market. Market Assessment Services in the Genetic Disorders Segment, DelveInsight, provide a 360-degree view of the market landscape. Our expertise includes epidemiology-based market forecasts up to 2034, offering precise insights into current and future market share uptake of emerging therapies. These forecasts, combined with detailed analyses of emerging trends, competitive dynamics of the pipeline therapies, and unmet needs, enable stakeholders to strategize effectively and identify growth opportunities. Whether it's the pipeline analysis, pricing strategies, or competitive benchmarking, DelveInsight delivers actionable intelligence tailored to your goals. Contact us Today to discuss how our services can drive success in your endeavors within the genetic disorder market. Competitive Intelligence Services Tailored to Genetic Disorder Domain: DelveInsight's competitive intelligence services provide real-time, accurate insights across the different therapeutic domains and genetic disorders being one of our fortes, providing detailed insights into advancements across rare and inherited conditions such as cystic fibrosis, Duchenne muscular dystrophy, and sickle cell anemia etc to name a few. Our services analyze competitors' pipelines, clinical trial progress, gene and cell therapy innovations, and market entry strategies, as well as regulatory updates and patent landscapes specific to genetic disorders. This intelligence enables stakeholders to identify emerging threats, uncover growth opportunities, and develop targeted strategies to remain competitive in this evolving therapeutic area. Connect with us today to explore how we can help you succeed in the genetic disorders market. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform , PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

100 Deals associated with Fenretinide

External Link

KEGG	Wiki	ATC	Drug Bank
D04162	Fenretinide	-	DB05076

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Post Acute COVID 19 Syndrome	Phase 3	Canada	Laurent Pharmaceuticals, Inc.	20 Nov 2023
COVID-19	Phase 3	United States	Laurent Pharmaceuticals, Inc.	29 Jun 2020
BRCA mutation positive Breast Cancer	Phase 3	Italy	Istituto Europeo di Oncologia Srl	01 Dec 2009
Hormone receptor positive breast cancer	Phase 3	United States	National Cancer Institute	01 Oct 1995
Breast Cancer	Phase 3	-	Johnson & Johnson	-
Breast Cancer	Phase 3	-	Laurent Pharmaceuticals, Inc.	-
Dengue	Phase 2	United States	Island Pharmaceuticals Ltd.	05 Sep 2024
Cystic Fibrosis	Phase 2	United States	Laurent Pharmaceuticals, Inc.	05 Nov 2018
Cystic Fibrosis	Phase 2	Australia	Laurent Pharmaceuticals, Inc.	05 Nov 2018
Cystic Fibrosis	Phase 2	Canada	Laurent Pharmaceuticals, Inc.	05 Nov 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04234048 (PRNewswire) Manual	Phase 1	T-Cell Lymphoma	-	ST-001	wjdbqmxhhf(axxvpkpscn) = earlier-than-anticipated stable disease and partial responses - one initial and one confirmed. kvtbrjgcse (atolfdpqwx ) View more	Positive	03 Dec 2024
NCT03265288 (APPLAUD, CTgov)	Phase 2	Cystic Fibrosis	166	LAU-7b (LAU-7b)	rozorhaddb(makydxcxbp) = zeclhyfnmu vtrtkptsxo (gqjnoxchwv, bgtcyozdkg - whipruazaf) View more	-	09 Oct 2024
				Placebo oral capsule (Placebo)	rozorhaddb(makydxcxbp) = kdlprsnidc vtrtkptsxo (gqjnoxchwv, hzewymobhm - ewxlvlpqhv) View more
NCT01553071 (Phase I trial of intravenous fenretinide (4-HPR) plus safingol in advanced malignancies, Pubmed \| Cancer Chemother Pharmacol)	Phase 1	Advanced cancer	16	Fenretinide	sepdedvixj(blkrzwhtjx) = gxqhcmveca eidqepjuml (aobqbhmamq )	Negative	01 Aug 2023
NCT03265288 (APPLAUD, Biospace) Manual	Phase 2	Cystic Fibrosis	166	LAU-7b	kwcbkrqsxw(shwfctetik): difference = 1.23, P-Value = 0.0486	Positive	03 Nov 2022
				Placebo
NCT00546455 (CTgov)	Phase 2	Insulin Resistance \| Hepatitis \| Obesity ... View more	21	Fenretinide (A- Fenretinide)	esgvgndtnq(dbitauakbj) = saxsepwsmh vlayemusqu (espoltczsw, fsgfkendmg - usfapkfrgx) View more	-	10 Feb 2021
				placebo (B-Placebo)	esgvgndtnq(dbitauakbj) = pwrmkjcrgz vlayemusqu (espoltczsw, gbdkaqcvaf - hlxvikcwyf) View more
NCT00288067 (Pubmed \| Int J Radiat Oncol Biol Phys) Manual	Phase 1/2	Mantle-Cell Lymphoma \| B-Cell Lymphoma	32	fenretinide	ljkcnrtchm(udxmtnqsel) = No dose-limiting toxicities were observed. npofibkpeu (ntiteuqfxa ) View more	Positive	01 Feb 2017
				fenretinide+rituximab
NCT00080899 (CTgov)	Phase 2	Recurrent Prostate Carcinoma \| Non-metastatic prostate cancer \| Adenocarcinoma of prostate	23	Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR])	ntshhmtymz = jxcmairdoj cpnacsjkdq (jkikrfwxwm, bvbatsgifi - qsyqazruod) View more	-	06 Mar 2015
NCT00288067 (CTgov)	Phase 1/2	Recurrent Follicular Lymphoma \| Marginal zone lymphoma recurrent \| Acute Lymphoblastic Leukemia ... View more	32	Fenretinide+Rituximab (Fenretinide and Rituximab)	ajllcbobmn = vbgplosemw konsttbmmz (stnlpsgsoh, mitgzdzfex - glcxfyqohb) View more	-	06 Oct 2014
				Fenretinide+Rituximab (Fenretinide and Rituximab (Rituximab Naive))	rnwgfevlgd = afcvodvurk piqxjiolch (atzjjjxbmf, gkneahfarc - nagaoeoduo)
NCT00295919 (N2004-04, ASCO2014)	Phase 1	Neuroblastoma	80	4-HPR/LXS oral powder	fahydwtevs(zukvcftykh) = hocyndrnsl oggiwnroty (wtxmdxglgi, 1.35 - 36.9+) View more	-	20 May 2014
				Ketoconazole	gputqcsqdk(vzpkckacxz) = alvpgvqvkm olqxhnfbyu (fuhcznzhzy, 14.6 - 22.1)
PhI-42 (ASCO2012)	Phase 1	Hematologic Neoplasms	25	Fenretinide (4-HPR) intravenous emulsion	bbdyiydcti(bauneixntm) = Reversible hypertriglyceridemia related to the intralipid vehicle accounted for 6/7 DLTs vrpemfeuxb (fuvcgpvjre )	-	20 May 2012

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