Roxane Laboratories

93 total trials 92 completed

Roxane Laboratories sponsors 93 registered US clinical trials on ClinicalTrials.gov, none currently recruiting, and 92 completed. 2 of these trials are in Phase 3-4 (later-stage) and 16 in Phase 1-2 (earlier-stage). The most-studied condition in this pipeline is Breast Cancer, with 4 trials.

Trial Pipeline

93 total, page 1 of 2

COMPLETED NA

Clinical Endpoint Bioequivalence Study for Fluticasone Propionate and Salmeterol Xinafoate

NCT02649478

TERMINATED Phase 3

A Study of Oral Codeine Sulfate in Pediatric Patients With Post-procedural Pain

NCT01676493

COMPLETED Phase 4

Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects

NCT01322360

COMPLETED Phase 1

Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions

NCT01703468

COMPLETED Phase 1

Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions

NCT01702623

COMPLETED Phase 1

Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

NCT01591889

COMPLETED Early Phase 1

Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions

NCT01903122

COMPLETED Early Phase 1

Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions

NCT01903109

COMPLETED Early Phase 1

Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions

NCT01659892

COMPLETED Early Phase 1

Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions

NCT01659905

COMPLETED NA

Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions

NCT01107353

COMPLETED Phase 1

Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions

NCT01210638

COMPLETED Phase 1

Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions

NCT01367626

COMPLETED Phase 1

Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fasted Conditions

NCT01367652

COMPLETED Phase 1

Dose Linearity Study of Codeine Sulfate Under Fasted Conditions

NCT01009697

COMPLETED Early Phase 1

Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions

NCT01659931

COMPLETED Early Phase 1

Bioequivalency Study of Montelukast 10 mg Tablets Under Fed Conditions

NCT01659918

COMPLETED Phase 1

Comparative Bioavailability Study of Codeine Sulfate

NCT01010152

COMPLETED Phase 1

Food Effect Study of Codeine Sulfate

NCT01009892

COMPLETED Phase 1

Steady State Study of Codeine Sulfate

NCT01009853

COMPLETED NA

Crossover Bioequivalence Study of Irbesartan Hydrochlorothiazide 300/25 mg Tablets Under Fed Conditions

NCT01712126

COMPLETED NA

Crossover Bioequivalence Study of Irbesartan HCTZ 300/25 mg Tablets Under Fasted Conditions

NCT01712139

COMPLETED NA

Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fasted Conditions

NCT01161667

COMPLETED NA

Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fed Conditions

NCT01161654

COMPLETED NA

Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fed Conditions

NCT01712100

COMPLETED NA

Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fasted Conditions

NCT01712113

COMPLETED NA

Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions

NCT01570894

COMPLETED NA

Bioequivalency Study of Famciclovir 500 mg Tablets Under Fed Conditions

NCT01321502

COMPLETED NA

Bioequivalency Study of Famciclovir 500 mg Tablets Under Fasted Conditions

NCT01321515

COMPLETED NA

Bioequivalency Study of Levetiracetam 1g Under Fasted Conditions

NCT00826722

COMPLETED NA

Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fasted Conditions

NCT01570907

COMPLETED NA

Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions

NCT00827320

COMPLETED NA

Bioequivalency Study of Perindopril Erbumine 8 mg Tablet Under Fed Conditions

NCT01013155

COMPLETED NA

Bioequivalency Study of Perindopril Erbumine 8 mg Tablet Under Fasted Conditions

NCT01012687

COMPLETED NA

Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Steady State Fasted Conditions

NCT01570959

COMPLETED NA

Dose Proportionality and Food Effect of Morphine Sulfate

NCT00994539

COMPLETED NA

Comparative Bioavailability Study of Morphine Sulfate Immediate Release and Controlled Release

NCT00994383

COMPLETED NA

Bioequivalency Study of Protriptyline 10 mg Tablets Under Fasted Conditions

NCT00754962

COMPLETED NA

Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions

NCT01132716

COMPLETED NA

Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions

NCT01132729

COMPLETED NA

Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions

NCT00992095

COMPLETED NA

Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions

NCT01010139

COMPLETED NA

Bioequivalency Study of Anastrozole 1 mg Under Fed Conditions

NCT01155089

COMPLETED NA

Bioequivalency Study of Morphine Sulfate Injection, Solution and Tablet Under Fasted Conditions

NCT00994942

COMPLETED NA

Bioequivalency Study of Anastrozole 1 mg Under Fasted Conditions

NCT01155102

COMPLETED NA

Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fasted Conditions

NCT00894088

COMPLETED NA

Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fed Conditions

NCT00893958

COMPLETED NA

Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions

NCT00893919

COMPLETED NA

Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasted Conditions

NCT00893542

COMPLETED NA

Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting Conditions

NCT00826865

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Phase Distribution

PhaseTrial count
Phase 1 16
Phase 3 1
Phase 4 1

What the Pipeline for Roxane Laboratories Shows

According to the ClinicalTrials.gov registry, Roxane Laboratories is linked to 93 US clinical trials across every stage of research activity. Of those, 0 studies are currently recruiting, about 0% of the sponsor's indexed portfolio, and 92 are already marked complete, representing roughly 99% of the total.

The phase mix for Roxane Laboratories reports 2 late-stage studies (Phase 3 and Phase 4 combined) and 16 earlier-phase studies (Phase 1 and Phase 2).

The top therapeutic focus area indexed for Roxane Laboratories is Breast Cancer with 4 linked trials, and 9 other condition areas appear in the top list above.

How to read these pipeline numbers

Recruiting share is one of the more practical signals here: it reflects how much of a sponsor's research is presently open to new participants, while the completed share indicates the depth of finished work that has already contributed registry results. Both counts come directly from the public ClinicalTrials.gov dataset and are refreshed on the registry side; this page mirrors the latest data pull without altering it.

A portfolio weighted toward Phase 3 usually reflects an organization advancing candidates toward regulatory review, where the research centers on comparative efficacy and broader safety across larger populations. A heavier Phase 1 and Phase 2 tilt generally indicates exploratory work, safety, dosing, and early signal detection, and is common among research-forward sponsors that seed many early programs. Phase 4 entries, when present, track interventions already in real-world use and typically focus on long-term safety, effectiveness across subgroups, or formulation comparisons.

That distribution is a quick read of where the organization concentrates its research attention; it does not imply product availability, market share, or any clinical endorsement. All numbers on this page come from ClinicalTrials.gov maintained by the National Library of Medicine, and counts can shift as new studies are registered or existing ones update their status. This information is provided for reference and educational purposes only, not as medical, investment, or regulatory advice, verify current details directly with ClinicalTrials.gov before relying on any figure here.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial from this sponsor, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.