Delving into the Latest Updates on OT-551 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

SOD1

Mechanism

SOD1 stimulants(Superoxide dismutase stimulants)

Therapeutic Areas

Nervous System DiseasesCongenital DisordersEndocrinology and Metabolic Disease+ [2]

Active Indication-

Inactive Indication

Cataractdry age-related macular degenerationDry Eye Syndromes+ [7]

Originator Organization

Colby Pharmaceutical Co.

Active Organization-

Inactive Organization

Othera Pharmaceuticals, Inc.

Colby Pharmaceutical Co.Colby

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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Structure

Molecular FormulaC13H23NO3

InChIKeyZWEXEKJLDHNLLA-UHFFFAOYSA-N

CAS Registry627085-11-4

View All Structures (2)

Othera Pharmaceuticals' Othera (OT)-551 antioxidant eye drop has the potential for chronic treatment of the dry form of age-related macular degeneration. This pilot study of up to 10 eye drop tolerant participants with bilateral geographic atrophy is designed to characterize the effect of 0.45% concentration of OT-551 eye drops given 3 times a day on the progression of geographic atrophy area over a two-year period. Participants will have one eye randomized to receive the eye drop and the fellow eye will be observed only.

Start Date01 Mar 2006

Sponsor / Collaborator

National Institutes of Health Clinical Center

[+2]

NCT00333060 / TerminatedPhase 2

Phase 2 Study of OT-551 Ophthalmic Solution to Prevent or Delay Progression of Nuclear Cataract Formation In Post-Vitrectomy Patients

The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively prevent or delay the progression of nuclear cataracts that frequently develop as a result of vitrectomy (surgery for retina repair), thereby avoiding the need for a second surgery (cataract removal). Victrectomies involve removal of the jelly-like substance (vitreous) that is located in a cavity behind the lens.

Start Date01 Nov 2005

Sponsor / Collaborator

Othera Pharmaceuticals, Inc.

100 Clinical Results associated with OT-551

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100 Translational Medicine associated with OT-551

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100 Patents (Medical) associated with OT-551

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6

Literatures (Medical) associated with OT-551

01 Sep 2013·Expert Review of Clinical PharmacologyQ2 · MEDICINE

Update on current and future novel therapies for dry age-related macular degeneration

Q2 · MEDICINE

Review

Author: Ella Leung ; Gennady Landa

Age-related macular degeneration (ARMD) is the leading cause of irreversible blindness in developed countries. There are currently no cures, but there are promising potential therapies that target the underlying disease mechanisms of dry ARMD. Stem cells, ciliary neurotrophic factor, rheopheresis, ozonated autohemotherapy and prostaglandins show promise in stabilizing or improving visual acuity. Age-Related Eye Disease Study vitamins may reduce progression to severe ARMD. Adjuvant therapy like low vision rehabilitation and implantable miniature telescopes may help patients adjust to the sequelae of their disease, and herbal supplementation with saffron, zinc monocysteine and phototrop may be helpful. Therapies that are currently in clinical trials include brimonidine, doxycycline, anti-amyloid antibodies (GSK933776 and RN6G), RPE65 inhibitor (ACU-4429), complement inhibitors (ARC1905, FCFD4514S), hydroxychloroquine, intravitreal fluocinolone acetate and vasodilators like sildenafil, moxaverine and MC-1101. Therapies that have not been shown to be effective include POT-4, eculizumab, tandospirone, anecortave acetate, the antioxidant OT-551, sirolimus and vitamin E.

01 Dec 2010·Investigative Opthalmology & Visual ScienceQ2 · MEDICINE

Treatment of Geographic Atrophy by the Topical Administration of OT-551: Results of a Phase II Clinical Trial

Q2 · MEDICINE

ArticleOA

Author: Meyerle, Catherine B. ; Harrington, Molly ; Ferris, Frederick L. ; Sadda, Srinivas R. ; Cunningham, Denise ; Chew, Emily Y. ; Hammel, Keri ; Wong, Wai T. ; Cukras, Catherine ; Kam, Waynekid

PURPOSETo investigate the safety and preliminary efficacy of OT-551, a disubstituted hydroxylamine with antioxidant properties, for the treatment of geographic atrophy (GA), the advanced atrophic form of age-related macular degeneration (AMD).METHODSThe study was a single-center, open-label phase II trial, enrolling 10 participants with bilateral GA. Topical 0.45% OT-551 was administered in one randomly assigned eye three times daily for 2 years. Safety measures were assessed by complete ophthalmic examination, fundus photography, and review of symptoms. The primary efficacy outcome measure was the change in best corrected visual acuity at 24 months. Secondary efficacy measures included changes in area of GA, contrast sensitivity, microperimetry measurements, and total drusen area from baseline.RESULTSStudy drug was well tolerated and was associated with few adverse events. The mean change in BCVA at 2 years was +0.2 ± 13.3 letters in the study eyes and -11.3 ± 7.6 letters in fellow eyes (P = 0.0259). However, no statistically significant differences were found between the study and fellow eyes for all other secondary outcome measures.CONCLUSIONSOT-551 was well tolerated by study participants and was not associated with any serious adverse effects. Efficacy measurements in this small study indicate a possible effect in maintaining visual acuity. However, the absence of significant effects on other outcomes measures in this study suggests that OT-551, in the current concentration and mode of delivery, may have limited or no benefit as a treatment for GA (ClinicalTrials.gov number, NCT00306488).

01 Jul 2010·Experimental Eye ResearchQ3 · MEDICINE

Protection of retinal pigment epithelium by OT-551 and its metabolite TEMPOL-H against light-induced damage in rats

Q3 · MEDICINE

Article

Author: Masaki Tanito ; Robert E. Anderson ; Feng Li

OT-551 (1-hydroxy-4-cyclopropanecarbonyloxy-2,2,6,6-tetramethylpiperidine hydrochloride), is a novel small molecule with antioxidant and anti-inflammatory effects. Protective efficacy of OT-551 and its metabolite TEMPOL-H (TP-H) against light-induced degeneration of retinal pigment epithelium (RPE) was tested. Albino rats were intraperitoneally injected with OT-551, TP-H, or water approximately 30 min prior to a 6 h exposure to 2700 lux white fluorescent light. Retinal protection was evaluated histologically by counting the RPE cell nuclei and measuring the extent of RPE damage on the retinal sections as RPE damage index (%). Following light exposure, the number of RPE cell nuclei was significantly reduced in light-exposed eyes from water-treated animals, while the number was not significantly different between light-exposed and unexposed eyes from the animals treated with 100 mg/kg TP-H or with any dose of OT-551 in the inferior hemisphere, and with 100 mg/kg OT-551 in the superior hemisphere. RPE damage index was significantly lower in the animals treated with any dose of OT-551 compared to water-treated animals both in the inferior and superior hemispheres. Systemic administration of OT-551 and TP-H provides RPE cell protection against acute light damage, and the protection by OT-551 was greater than by TP-H.

100 Deals associated with OT-551

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cataract	Phase 3	US	Colby	11 Dec 2012
Dry Eye Syndromes	Phase 3	US	Othera Pharmaceuticals, Inc.	-
Glaucoma	Phase 2	US	Colby Pharmaceutical Co.	19 Sep 2012
Lacrimal gland disease	Phase 2	US	Colby Pharmaceutical Co.	19 Sep 2012
dry age-related macular degeneration	Phase 2	US	Othera Pharmaceuticals, Inc.	01 Jun 2007
Geographic Atrophy	Phase 2	US	Othera Pharmaceuticals, Inc.	01 Mar 2006
Glycogen Storage Disease Type II	Phase 2	US	Othera Pharmaceuticals, Inc.	01 Mar 2006
Epiretinal Membrane	Phase 2	US	Othera Pharmaceuticals, Inc.	01 Nov 2005
Nuclear cataract	Phase 2	US	Othera Pharmaceuticals, Inc.	01 Nov 2005
Retinal Perforations	Phase 2	US	Othera Pharmaceuticals, Inc.	01 Nov 2005

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00306488 (Pubmed \| Invest Ophthalmol Vis Sci)	Phase 2	Geographic Atrophy	10	OT-551 0.45%	(eyagyfuegp) = mqwxwmdkun vrlzgvujab (igybegapjn )	Negative	01 Dec 2010
NCT00485394 (ARVO2010)	Phase 2	Geographic Atrophy	137	OT-551 0.3%	(xslwcrixji) = kpriwhhywd ykczrzznvx (ryhmxqukmb ) View more	Negative	01 Apr 2010
NCT00485394 (ARVO2010)	Phase 2	Geographic Atrophy	137	OT-551 0.45%	(xslwcrixji) = dbdbdvdtta ykczrzznvx (ryhmxqukmb ) View more	Negative	01 Apr 2010
NCT00306488 (Phase I/II Clinical Trial, ARVO2010)	Phase 1/2	Geographic Atrophy	10	OT-551 0.45%	(ujkafiixnv) = qyuaytefqa xmljohtquu (ojkkhysnog )	Positive	01 Apr 2010