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RAR Gamma

Phase 2

Emphysema | Small molecule | Respiratory |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment491

FDA Designations

No designations recorded

Clinical trial landscape

RAR Gamma · 1 trial · 1 indication

Phase 2 1
NCT00413205TESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)Emphysema
COMPLETED491 Analytics
PHASE2COMPLETED
TESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)
EmphysemaUnlock trial analytics

Study Endpoints

Primary Endpoints

Post-bronchodilator FEVI
At intervals throughout study, and 2 and 6 months after cessation of study drug

Secondary Endpoints

DLCo, lung densitometry, SGRQ, lung volume, walk test, time to first COPD exacerbation.
At intervals throughout study
AEs, SAEs, retinoid side effects, lab parameters.
Thoughout study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORpo daily
RAR GammaEXPERIMENTAL5mg po daily

Interventions

NameTypeDescription
PlaceboDRUGpo daily
RAR GammaDRUG5mg po daily
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Eligibility Criteria

Age Range44 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites64

Inclusion Criteria: * patients of \>44 years of age, with \>10 pack-year smoking history; * women not of child-bearing potential; * ex-smokers (must have stopped smoking for \>=12 months) with clinical diagnosis of emphysema; * willing to be switched to optimal COPD therapy. Exclusion Criteria: *...

Countries:United StatesBulgariaCzechiaHungaryIcelandIsraelItalyLatviaPolandSouth AfricaUkraineUnited Kingdom
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Frequently asked questions about RAR Gamma

What is RAR Gamma used for in emphysema?

RAR Gamma is an investigational small molecule being studied for the treatment of emphysema, a form of chronic obstructive pulmonary disease. It is a gamma-selective retinoid agonist that was evaluated in a Phase 2 clinical trial. The drug is not approved and remains in clinical development.

What does RAR Gamma target?

RAR Gamma targets the retinoic acid receptor gamma, a nuclear receptor involved in cell growth and differentiation. As a gamma-selective retinoid agonist, it is designed to activate this specific receptor subtype. The drug was investigated for its potential to treat emphysema by promoting alveolar repair.

Who makes RAR Gamma?

RAR Gamma is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker RHHBY on the OTC market. The company conducted a Phase 2 clinical trial of RAR Gamma for emphysema.

What phase is RAR Gamma in?

RAR Gamma is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not received FDA approval. Its development status is based on the completed Phase 2 trial.

What clinical trials is RAR Gamma in?

RAR Gamma has one completed Phase 2 clinical trial, identified as NCT00413205, titled TESRA (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist). This trial enrolled 491 participants with emphysema across multiple countries, including the United States, Bulgaria, Czechia, Hungary, Iceland, Israel, Italy, Latvia, Poland, South Africa, Ukraine, and the United Kingdom.