MedPath

Regulus Therapeutics

🇺🇸United States
Ownership
-
Employees
30
Market Cap
$117.8M
Website
Introduction

Regulus Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the discovery and development of drugs targeting microRNAs. Its two lead product candidates, RG-012 and RGLS4326, are in clinical development. RG-012 is an anti-miR targeting miR-21 in Phase II clinical trial for the treatment of Alport syndrome, a life-threatening kidney disease. RGLS4326 is an anti-miR targeting miR-17 in Phase I clinical trial for the treatment of autosomal dominant polycystic kidney disease. The firm is also developing a pipeline of preclinical drug product candidates in renal, hepatic, and central nervous systems diseases. The company was founded in 2007 and is headquartered in San Diego, CA.

Clinical Trials

12

Active:8
Completed:4

Trial Phases

1 Phases

Phase 1:11

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (11 trials with phase data)• Click on a phase to view related trials

Phase 1
11 (100.0%)

A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease

Phase 1
Completed
Conditions
Autosomal Dominant Polycystic Kidney Disease
ADPKD
Polycystic Kidney, Autosomal Dominant
Interventions
Drug: Placebo
First Posted Date
2022-08-30
Last Posted Date
2025-06-03
Lead Sponsor
Regulus Therapeutics Inc.
Target Recruit Count
68
Registration Number
NCT05521191
Locations
🇺🇸

Centricity Research Phoenix Multispecialty, Mesa, Arizona, United States

🇺🇸

Academic Medical Research Institute, Los Angeles, California, United States

🇺🇸

Yale Nephrology Outpatient Clinic, New Haven, Connecticut, United States

and more 17 locations

A Study of RGLS8429 in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Placebo volume-matching RGLS8429 dose
First Posted Date
2022-06-23
Last Posted Date
2022-10-13
Lead Sponsor
Regulus Therapeutics Inc.
Target Recruit Count
36
Registration Number
NCT05429073
Locations
🇺🇸

ICON Early Phase Services, San Antonio, Texas, United States

A Study of RGLS4326 in Patients With Autosomal Dominant Polycystic Kidney Disease

Phase 1
Completed
Conditions
Polycystic Kidney Disease, Autosomal Dominant
Interventions
First Posted Date
2020-09-03
Last Posted Date
2021-12-15
Lead Sponsor
Regulus Therapeutics Inc.
Target Recruit Count
19
Registration Number
NCT04536688
Locations
🇺🇸

Balboa Nephrology Medical Group, La Mesa, California, United States

🇺🇸

Academic Medical Research Institute, Los Angeles, California, United States

🇺🇸

Yale Nephrology Clinical Research, New Haven, Connecticut, United States

and more 9 locations

News

Renasant Bio Raises $54.5M to Develop Novel Ion Channel Therapies for ADPKD

Renasant Bio secured $54.5 million in seed funding from investors including 5AM Ventures, Atlas Venture, OrbiMed and Qiming Venture Partners USA to develop treatments for autosomal dominant polycystic kidney disease (ADPKD).

Investor Lawsuit Challenges Novartis' $1.7 Billion Acquisition of Regulus Therapeutics Over Kidney Disease Drug

A shareholder lawsuit seeks to block Novartis' acquisition of Regulus Therapeutics, alleging the deal primarily benefits company insiders rather than public stockholders.

Novartis Launches $7 Tender Offer for Regulus Therapeutics with Additional Regulatory Milestone Payment

Novartis has commenced a tender offer to acquire all outstanding shares of Regulus Therapeutics for $7.00 per share in cash plus one contingent value right per share.

Novartis Acquires Regulus Therapeutics for $800M, Expanding Kidney Disease Portfolio

Novartis has agreed to acquire Regulus Therapeutics for $800 million upfront, with potential additional payments of up to $900 million tied to regulatory milestones.

Big Pharma M&A Activity Surges as Companies Target Undervalued Biotechs Amid Market Recovery

Pharmaceutical M&A activity is experiencing a significant rebound with major deals including Novartis's $1.7 billion acquisition of Regulus Therapeutics and Merck KGaA's $3.9 billion purchase of SpringWorks Therapeutics.

Robust Pipeline of 80+ Therapies Advancing for Chronic Kidney Disease Treatment in 2025

DelveInsight's 2025 report reveals a robust pipeline with 75+ companies developing 80+ therapies for chronic kidney disease, highlighting significant industry investment in addressing this growing health concern.

Global Polycystic Kidney Disease Clinical Trials Landscape Mapped in Comprehensive 2025 Review

New comprehensive report provides critical insights into the global clinical trial landscape for Polycystic Kidney Disease, covering regional distribution, trial phases, and sponsor involvement across G7 and E7 countries.

Regulus Therapeutics' Farabursen Shows Promise in ADPKD Phase 1b Trial and Gains FDA Agreement on Phase 3 Design

Regulus Therapeutics announced positive topline results from an interim analysis of the Phase 1b MAD study of farabursen for ADPKD.

Regulus Therapeutics Reports Mixed Results for ADPKD Program, Shares Drop 24%

Regulus Therapeutics' stock experienced a significant 24% decline following the announcement of interim analysis results for their ADPKD treatment program.

Antisense Oligonucleotide Therapies Advance in Genetic Medicine

• Ionis Pharmaceuticals, a pioneer in antisense oligonucleotide (ASO) drugs, priced a $500 million IPO to fund clinical programs and commercial launches. • Isarna Therapeutics' lead candidate, ISTH0036, targeting TGF-β, shows promise in Phase 2 trials for wet AMD and DME, major ophthalmic conditions. • Regulus Therapeutics is advancing RGLS8429, an ASO targeting microRNA for autosomal dominant polycystic kidney disease (ADPKD), with positive Phase 1b data. • Sarepta Therapeutics, with three approved PPMO therapies for Duchenne muscular dystrophy (DMD), continues to expand its RNA-based therapeutic pipeline.

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