Last reviewed 2026-06-03 · How we verify

BiDil XR

Arbor Pharmaceuticals, Inc. · FDA-approved active Small molecule ✓ Verified Jun 2026 Quality 51/100

BiDil XR is a Vasodilators Small molecule drug developed by Arbor Pharmaceuticals, Inc.. It is currently FDA-approved. Also known as: BiDil capsules, hydralazine HCl + isosorbide dinitrate.

BiDil XR combines isosorbide dinitrate and hydralazine to enhance vasodilation and reduce cardiac workload, specifically benefiting patients with heart failure.

BiDil XR is a small molecule medication used to treat heart failure. It is available in extended-release and immediate-release formulations, with the extended-release formulation being studied in a pharmacodynamic and pharmacokinetic study.

At a glance

Generic name	BiDil XR
Also known as	BiDil capsules, hydralazine HCl + isosorbide dinitrate
Sponsor	Arbor Pharmaceuticals, Inc.
Drug class	Vasodilators
Target	Vasculature and cardiac function
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	FDA-approved

Mechanism of action

Isosorbide dinitrate is a nitrate that dilates blood vessels, reducing the heart's workload, while hydralazine is a direct-acting vasodilator that relaxes vascular smooth muscle, further lowering blood pressure.

Approved indications

Common side effects

Headache
Dizziness
Nausea
Hypotension
Flushing

Drug interactions

Concomitant use with phosphodiesterase inhibitors may cause severe hypotension
Use with other vasodilators or antihypertensives may increase the risk of hypotension

Key clinical trials

Pharmacodynamic and Pharmacokinetic Study of BiDil Extended-release Capsules and Commercial BiDil Tablets (PHASE1)

Patents

Patent	Expiry	Type
US7846445B2
US8273381B2

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results
FDA Orange Book	Patents + exclusivity

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

BiDil XR CI brief — competitive landscape report
BiDil XR updates RSS · CI watch RSS
Arbor Pharmaceuticals, Inc. portfolio CI

Frequently asked questions about BiDil XR

What is BiDil XR?

BiDil XR is a Vasodilators drug developed by Arbor Pharmaceuticals, Inc..

How does BiDil XR work?

BiDil XR combines isosorbide dinitrate and hydralazine to enhance vasodilation and reduce cardiac workload, specifically benefiting patients with heart failure.

Who makes BiDil XR?

BiDil XR is developed and marketed by Arbor Pharmaceuticals, Inc. (see full Arbor Pharmaceuticals, Inc. pipeline at /company/arbor-pharmaceuticals-inc).

Is BiDil XR also known as anything else?

BiDil XR is also known as BiDil capsules, hydralazine HCl + isosorbide dinitrate.

What drug class is BiDil XR in?

BiDil XR belongs to the Vasodilators class. See all Vasodilators drugs at /class/vasodilators.

What development phase is BiDil XR in?

BiDil XR is FDA-approved (marketed).

What are the side effects of BiDil XR?

Common side effects of BiDil XR include Headache, Dizziness, Nausea, Hypotension, Flushing.

What does BiDil XR target?

BiDil XR targets Vasculature and cardiac function and is a Vasodilators.

Drug class: All Vasodilators drugs
Target: All drugs targeting Vasculature and cardiac function
Manufacturer: Arbor Pharmaceuticals, Inc. — full pipeline
Therapeutic area: All drugs in Cardiovascular
Also known as: BiDil capsules, hydralazine HCl + isosorbide dinitrate

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing