Drugs / fenretinide
last change May 2026 re-read 9 days ago

fenretinide

Small molecule

Developed for
neuroblastoma · cancer of unknown primary site · head and neck cancer · breast cancer · ovarian cancer · peripheral T-cell lymphoma, not otherwise specified · primary peritoneal carcinoma · acute lymphoblastic leukemia
+41 more · acute myeloid leukemia · adult glioblastoma · adult nodular lymphocyte predominant Hodgkin lymphoma · angioimmunoblastic T-cell lymphoma · Burkitt lymphoma · cancer · central nervous system neoplasm · cervical cancer · childhood malignant neoplasm · chronic lymphocytic leukemia/small lymphocytic lymphoma · cutaneous melanoma · cystic fibrosis · diffuse large B-cell lymphoma · dysplasia of cervix · giant cell glioblastoma · gliosarcoma · hereditary neoplastic syndrome · kidney cancer · leukemia · lung cancer · lymphoma · malignant epithelial tumor of ovary · mantle cell lymphoma · mycosis fungoides · myeloproliferative neoplasm · nodal marginal zone B-cell lymphoma · Nodal T-follicular helper cell lymphoma, follicular type · obesity disorder · oral mucosa leukoplakia · ovarian carcinoma · plasma cell neoplasm · prostate adenocarcinoma · prostate cancer · schizophrenia · Sezary syndrome · small cell lung carcinoma · splenic marginal zone lymphoma · urinary bladder cancer · Waldenstrom macroglobulinemia · diffuse secondary choroid atrophy · dry age related macular degeneration
Investigated by
National Cancer Institute (NCI) · South Plains Oncology Consortium · M.D. Anderson Cancer Center · Barbara Ann Karmanos Cancer Institute · California Cancer Consortium · Eastern Cooperative Oncology Group
+20 more · New Approaches to Neuroblastoma Therapy Consortium · Ohio State University Comprehensive Cancer Center · SWOG Cancer Research Network · SciTech Development, Inc. · Beersheva Mental Health Center · Cancer Therapeutics Research Group · Cancer and Leukemia Group B · Case Comprehensive Cancer Center · CerRx, Inc. · Elias Matouk · European Institute of Oncology · Gynecologic Oncology Group · National Institutes of Health Clinical Center (CC) · North Central Cancer Treatment Group · Schering-Plough · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · The Evan Foundation · University of Alabama at Birmingham · University of Arizona · University of California, San Diego

Trials 42

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 118 trials
Phase 1 NCT06922539 Dec 2025 → May 2027 expected small cell lung carcinoma SciTech Development, Inc. Recruiting No outcome recorded
Phase 1 NCT07149220 Oct 2025 → May 2026 oral mucosa leukoplakia Ohio State University Comprehensive Cancer Center Completed No outcome recorded
Phase 1 NCT04234048 Dec 2023 → Jun 2028 expected Nodal T-follicular helper cell lymphoma, follicular type, Sezary syndrome, angioimmunoblastic T-cell lymphoma, mycosis fungoides +1 SciTech Development, Inc. Recruiting No outcome recorded
Phase 1 NCT01553071 Nov 2016 → Dec 2020 cancer South Plains Oncology Consortium Terminated No outcome recorded
Phase 1 NCT02163356 May 2014 → May 2018 neuroblastoma South Plains Oncology Consortium Terminated No outcome recorded
Phase 1 NCT02141958 Apr 2014 → Feb 2015 cystic fibrosis Elias Matouk Completed No outcome recorded
Phase 1 NCT01187810 Aug 2010 → Apr 2018 acute lymphoblastic leukemia, acute myeloid leukemia South Plains Oncology Consortium Terminated No outcome recorded
Phase 1 NCT00589381 Aug 2007 → Dec 2010 cancer of unknown primary site, lymphoma National Institutes of Health Clinical Center (CC) Completed No outcome recorded
Phase 1 NCT00646230 Dec 2006 → Mar 2012 neuroblastoma New Approaches to Neuroblastoma Therapy Consortium Completed No outcome recorded
Phase 1 NCT00387504 Nov 2006 → Jul 2013 cancer of unknown primary site California Cancer Consortium Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT01535157 Feb 2012 → Jun 2017 ovarian cancer, primary peritoneal carcinoma South Plains Oncology Consortium Terminated No outcome recorded
Phase 1/2 NCT00288067 Oct 2005 → Jul 2013 Burkitt lymphoma, Waldenstrom macroglobulinemia, adult nodular lymphocyte predominant Hodgkin lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma +4 National Cancer Institute (NCI) Terminated No outcome recorded
Phase 214 trials · 1 missed
Phase 2 NCT02495415 Dec 2016 → Jul 2021 peripheral T-cell lymphoma, not otherwise specified CerRx, Inc. Unknown No outcome recorded
Phase 2 NCT00546455 Dec 2007 → Jan 2012 obesity disorder University of California, San Diego Suspended No outcome recorded
Phase 2 NCT00080899 Jun 2004 → Jan 2009 prostate adenocarcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00075491 Dec 2003 → Mar 2005 adult glioblastoma, giant cell glioblastoma, gliosarcoma National Cancer Institute (NCI) Terminated No outcome recorded
Phase 2 NCT00077402 Nov 2003 → Jan 2011 prostate cancer Cancer Therapeutics Research Group Completed No outcome recorded
Phase 2 NCT00053326 May 2003 → Mar 2006 neuroblastoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00026091 Sep 2001 → Mar 2004 malignant epithelial tumor of ovary, primary peritoneal carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00011973 Dec 2000 → Oct 2005 kidney cancer Barbara Ann Karmanos Cancer Institute Completed No outcome recorded
Phase 2 NCT00009971 Nov 2000 → Sep 2005 lung cancer National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT00006080 Sep 2000 → Sep 2004 central nervous system neoplasm Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Completed Missed primary
Phase 35 trials · 1 missed
Phase 3 NCT01479192 Dec 2009 → Dec 2015 hereditary neoplastic syndrome European Institute of Oncology Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT00004154 Jul 1998 → Mar 2005 urinary bladder cancer M.D. Anderson Cancer Center Completed Missed primary
Phase 3 NCT00002646 Oct 1995 → Feb 2004 breast cancer Eastern Cooperative Oncology Group Completed No outcome recorded
Phase 3 NCT00003075 Mar 1993 → May 2001 cervical cancer, dysplasia of cervix M.D. Anderson Cancer Center Completed No outcome recorded
Phase 3 NCT00534898 — schizoaffective disorder, schizophrenia Beersheva Mental Health Center Withdrawn No outcome recorded Stop: Business
Phase not applicable2 trials
— NCT00098800 Oct 2004 → Aug 2006 BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, ovarian cancer University of Arizona Completed No outcome recorded
— NCT00017134 Sep 2002 → Dec 2006 ovarian carcinoma Gynecologic Oncology Group Terminated No outcome recorded Stop: Enrollment
Phase not stated1 trial
— NCT02075177 — neuroblastoma South Plains Oncology Consortium No longer available No outcome recorded
Comparator or background therapy3 trials
Phase 1 NCT06181760 Comparator Nov 2023 → Feb 2024 — Island Pharmaceuticals Completed No outcome recorded
Phase 2 NCT00429936 Comparator Dec 2006 → May 2010 diffuse secondary choroid atrophy, dry age related macular degeneration Sirion Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT00003099 Comparator May 1996 → Jun 2000 breast cancer M.D. Anderson Cancer Center Completed No outcome recorded

News releases announcing trial results or a regulatory action · 7

DateIssuerRelease
2025-08-14 Island Pharmaceuticals Results Presentation to the Third Annual Dengue Endgame Summit irmau.com ↗
The attached presentation provides further data from the Company’s recently completed Phase 2a/b PROTECT trial using ISLA-101 (refer ASX announcement: 12 June 2025), supporting the ongoing development of the molecule as a dengue countermeasure.
2024-06-03 Island Pharmaceuticals Results Investor Presentation irmau.com ↗
ISLA-101 was safe and well tolerated
2024-04-22 Island Pharmaceuticals Results Investor Presentation - Asia Bio Partnering irmau.com ↗
ISLA-101 was shown to be safe and well tolerated
2023-05-16 Island Pharmaceuticals Regulatory Island receives FDA go-ahead for ISLA-101 program irmau.com ↗
Lifting of the Clinical Hold will allow the Company to proceed with the Single Ascending Dose study requested by the FDA.
2022-03-15 SciTech Development, Inc. Regulatory SciTech Announces Launch of Equity Crowdfunding Campaign on StartEngine scitechdevelopment.com ↗
We are also pleased to announce that ST-001 has an FDA approved Investigational New Drug Application (IND) and Orphan Drug Designation (ODD) for two types of NHL: peripheral T-cell lymphoma (PTCL) and cutaneous T -cell lymphoma (CTCL).
2019-12-23 SciTech Development, Inc. Regulatory FDA Accepts SciTech's IND Application for ST-001 nanoFenretinide in Patients with T-Cell Lymphoma scitechdevelopment.com ↗
The U.S. Food and Drug Administration (FDA) has accepted SciTech Development's Investigational New Drug (IND) Application for ST-001 nanoFenretinide, an experimental treatment for T-cell non-Hodgkin's lymphoma (NHL).
2018-02-01 SciTech Development, Inc. Regulatory SciTech’s Oncology Drug Granted Orphan Status scitechdevelopment.com ↗
SciTech Development is pleased to announce that the U.S. Food & Drug Administration (FDA) has recently granted its lead drug product ST-001 Orphan Drug Status for the treatment of T-cell lymphoma.

All press releases naming this drug 7 releases

DateIssuerRelease

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 49 sources stand behind the page.

FieldValueCited text
Known as Fenretinide “Fenretinide is an anticancer agent that may work differently than standard chemotherapy medicines.” NCT02075177 ↗
44

NCT01479192 ↗

NCT00003250 ↗

NCT01535157 ↗

NCT02495415 ↗

NCT00006471 ↗

NCT00017134 ↗

NCT00026091 ↗

NCT06181760 ↗

NCT02141958 ↗

NCT00005819 ↗

Show 34 more sources

Known as 4-HPR “Induction of apoptosis is a unique feature of fenretinide (4-hydroxyphenylretinamide, 4-HPR),(2) the most widely studied retinoid in clinical trials of breast cancer...” NCT01479192 ↗
10

“A Multicenter Randomized Double-Blinded Trial for Chemoprevention of Ovarian Cancer: Modulation of Biomarkers and Spectral Properties Using Contrast Enhanced Ultrasound in...” NCT00098800 ↗

“The synthetic retinoid fenretinide (N-(4-hydroxyphenyl)retinamide, 4-HPR) has shown promising anticancer activity in preclinical studies, but its limited oral bioavailability...” PMID 21498721 ↗ Mar 2011

“A Randomized, Double Blind, Placebo-Controlled Phase II Clinical Trial of N(4-Hydroxy-phenyl)Retinamide (Fenretinide, 4HPR) in Oral Leukoplakia” NCT00004161 ↗

“Phase I Study of Fenretinide (4-HPR, NSC 374551) Lym-X-Sorb™ (LXS) Oral Powder in Patients With Recurrent or Resistant Neuroblastoma” NCT00295919 ↗

“To evaluate the efficacy of fenretinide (4-HPR) in patients with recurrent ovarian cancer or primary peritoneal carcinoma.” NCT00026091 ↗

“Fenretinide (4-HPR) is a synthetic retinoid that induces cytotoxicity through dihydroceramide production.” PMID 37199745 ↗ May 2023

“4-HPR (Fenretinide) is given as a continuous intravenous infusion (CIV) for five consecutive days.” NCT00387504 ↗

“A Phase II Trial of Fenretinide (4-HPR) in Biochemically Recurrent, Hormone Naive Prostate Cancer” NCT00080899 ↗

“Phase I Trial of Intravenous Fenretinide (4-HPR) for Patients With Hematologic Malignancies” NCT00104923 ↗

“Fenretinide (4-HPR)” NCT00102635 ↗

Known as 4-hydroxyphenylretinamide “Induction of apoptosis is a unique feature of fenretinide (4-hydroxyphenylretinamide, 4-HPR),(2) the most widely studied retinoid in clinical trials of breast cancer...” NCT01479192 ↗
Known as Dihydroceramide N-(4-Hydroxyphenyl retinamide) “fenretinide (Dihydroceramide N-(4-Hydroxyphenyl retinamide) on severity” NCT00534898 ↗
Known as FMS “The goal of this clinical trial is to determine the effect of a mucoadhesive system that releases the vitamin A derivative, fenretinide (FMS), on precancerous surface...” NCT07149220 ↗
Known as HPR “Determine the maximum tolerated dose of fenretinide (HPR) in children with high risk solid tumors.” NCT00003191 ↗
Known as IND-40, 294 “Phase II Trial Of Fenretinide (NSC-374551; IND-40, 294) In Patients With Relapsed Small Cell Lung Cancer” NCT00009971 ↗
Known as LXS “The purpose of this study is to determine the effectiveness of fenretinide (4-HPR/LXS) plus ketoconazole in the treatment of recurrent ovarian cancer or primary peritoneal carcinoma.” NCT01535157 ↗
Known as N-(4-hydroxyphenyl)retinamide “The synthetic retinoid fenretinide (N-(4-hydroxyphenyl)retinamide, 4-HPR) has shown promising anticancer activity in preclinical studies, but its limited oral bioavailability...” PMID 21498721 ↗ Mar 2011
1

“A Randomized, Double Blind, Placebo-Controlled Phase II Clinical Trial of N(4-Hydroxy-phenyl)Retinamide (Fenretinide, 4HPR) in Oral Leukoplakia” NCT00004161 ↗

Known as NSC 374551 “Phase II study of fenretinide (NSC 374551) in adults with recurrent malignant gliomas: A North American Brain Tumor Consortium study.” PMID 15514370 ↗ Nov 2004
4

“Fenretinide (4-HPR, NSC 374551) Lym-X-Sorb (LXS) Oral Powder Plus Ketoconazole in Patients With Recurrent or Resistant Neuroblastoma” NCT02075177 ↗

“Phase I Study of Fenretinide (4-HPR, NSC 374551) Lym-X-Sorb™ (LXS) Oral Powder in Patients With Recurrent or Resistant Neuroblastoma” NCT00295919 ↗

“Phase II Trial Of Fenretinide (NSC-374551; IND-40, 294) In Patients With Relapsed Small Cell Lung Cancer” NCT00009971 ↗

“A Phase I Study of Fenretinide (NSC #374551) in Children With High Risk Solid Tumors” NCT00003191 ↗

Modality Small molecule “Fenretinide, a synthetic form of retinoid” PMID 15744595 ↗ Mar 2005
Route Oral “Patients also receive either oral fenretinide or oral placebo daily for 5 years, beginning within 2 weeks after completion of any radiotherapy, or within 2 weeks of...” NCT00002646 ↗