Androxal

Phase 3Small molecule

RRepros Therapeutics Inc.

Androxal is one of 86 small molecule programs targeting Hypogonadism. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

HypogonadismActive, not recruiting

Hypogonadotropic HypogonadismActive, not recruiting

Diabetes MellitusActive, not recruiting

HypogonadismPhase 2

Active, not recruiting

Hypogonadotropic HypogonadismPhase 3

Active, not recruiting

Diabetes MellitusPhase 2

Active, not recruiting

Competition

Competitive Landscape

286 competitors in Diabetes Mellitus

#DrugCompanyPhaseTrials

Glucagon

XXeris Pharmaceuticals

Phase 3

2 2

Xylocaine

CCitius Pharmaceuticals, Inc.

Phase 3

—3

Androxal

RRepros Therapeutics Inc.

Phase 3

1 4

Trulicity

Eli Lilly

Preclinical

2 5

Byetta

AstraZeneca

Preclinical

2 6

Edarbi

Takeda

Preclinical

1 7

NOVOLIN R

Novo Nordisk

Preclinical

1 8

Galvus

Novartis

Preclinical

1 9

Simponi

Johnson & Johnson

Preclinical

1 10

Paxil CR

GSK

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Hypogonadism9 trials

Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism

Completed·RRepros Therapeutics Inc.·Phase 3·NCT00962637·194 enrolled

Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

Completed·RRepros Therapeutics Inc.·Phase 2·NCT01270841·83 enrolled

Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

Completed·RRepros Therapeutics Inc.·Phase 3·NCT01534208·499 enrolled

Show 6 more trials

Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism

Completed·RRepros Therapeutics Inc.·Phase 3·NCT01067365·104 enrolled

An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

Completed·RRepros Therapeutics Inc.·Phase 3·NCT01739582·300 enrolled

To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone

Completed·RRepros Therapeutics Inc.·Phase 2·NCT00706719·17 enrolled

A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203

Completed·RRepros Therapeutics Inc.·Phase 2·NCT01386567·48 enrolled

The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

Completed·RRepros Therapeutics Inc.·Phase 2·NCT01386606·60 enrolled

Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism

Completed·RRepros Therapeutics Inc.·Phase 3·NCT01532414·151 enrolled

Tics2 trials

Study to Evaluate the Effect of Food Upon the Pharmacokinetics of Androxal

Completed·RRepros Therapeutics Inc.·Phase 1·NCT02146391·12 enrolled

An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal

Completed·RRepros Therapeutics Inc.·Phase 1·NCT02169804·24 enrolled

Hypogonadotropic Hypogonadism2 trials

A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%

Completed·RRepros Therapeutics Inc.·Phase 3·NCT01993225·120 enrolled

Completed·RRepros Therapeutics Inc.·Phase 3·NCT01993212·120 enrolled

Absorption1 trial

An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration

Completed·RRepros Therapeutics Inc.·Phase 1·NCT02274181·6 enrolled

Drug Interactions1 trial

Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males

Completed·RRepros Therapeutics Inc.·Phase 1·NCT01991327·30 enrolled

6 more indications

Impaired Renal Function1 trial

Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function

Completed·RRepros Therapeutics Inc.·Phase 1·NCT01923857·26 enrolled

Hepatic Function1 trial

Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function

Completed·RRepros Therapeutics Inc.·Phase 1·NCT01923870·19 enrolled

ESS1 trial

A Thorough QT/QTc Study to Assess the Effects of Androxal in Healthy Male Subjects

Completed·RRepros Therapeutics Inc.·Phase 1·NCT02117830·54 enrolled

MPA1 trial

Comparison of Two Formulations of Androxal

Completed·RRepros Therapeutics Inc.·Phase 1·NCT01984398·16 enrolled

Single Dose1 trial

A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal

Completed·RRepros Therapeutics Inc.·Phase 1·NCT01959685·9 enrolled

Diabetes Mellitus1 trial

Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus

Completed·RRepros Therapeutics Inc.·Phase 2·NCT01191320·102 enrolled

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Androxal. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Androxal compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Androxal. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Repros Therapeutics Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: RRepros Therapeutics Inc.

Androxal

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Hypogonadism9 trials

Tics2 trials

Hypogonadotropic Hypogonadism2 trials

Absorption1 trial

Drug Interactions1 trial

Impaired Renal Function1 trial

Hepatic Function1 trial

ESS1 trial

MPA1 trial

Single Dose1 trial

Diabetes Mellitus1 trial

References

Drug Info

Quick Facts

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