Roxane Laboratories
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
Clinical Endpoint Bioequivalence Study for Fluticasone Propionate and Salmeterol Xinafoate
NCT02649478
A Study of Oral Codeine Sulfate in Pediatric Patients With Post-procedural Pain
NCT01676493
Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects
NCT01322360
Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions
NCT01703468
Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions
NCT01702623
Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions
NCT01591889
Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions
NCT01903122
Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions
NCT01903109
Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions
NCT01659892
Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions
NCT01659905
Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions
NCT01107353
Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions
NCT01210638
Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions
NCT01367626
Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fasted Conditions
NCT01367652
Dose Linearity Study of Codeine Sulfate Under Fasted Conditions
NCT01009697
Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions
NCT01659931
Bioequivalency Study of Montelukast 10 mg Tablets Under Fed Conditions
NCT01659918
Comparative Bioavailability Study of Codeine Sulfate
NCT01010152
Food Effect Study of Codeine Sulfate
NCT01009892
Steady State Study of Codeine Sulfate
NCT01009853
Crossover Bioequivalence Study of Irbesartan Hydrochlorothiazide 300/25 mg Tablets Under Fed Conditions
NCT01712126
Crossover Bioequivalence Study of Irbesartan HCTZ 300/25 mg Tablets Under Fasted Conditions
NCT01712139
Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fasted Conditions
NCT01161667
Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fed Conditions
NCT01161654
Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fed Conditions
NCT01712100
Crossover Bioequivalence Study of Irbesartan 300 mg Tablets Under Fasted Conditions
NCT01712113
Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions
NCT01570894
Bioequivalency Study of Famciclovir 500 mg Tablets Under Fed Conditions
NCT01321502
Bioequivalency Study of Famciclovir 500 mg Tablets Under Fasted Conditions
NCT01321515
Bioequivalency Study of Levetiracetam 1g Under Fasted Conditions
NCT00826722
Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fasted Conditions
NCT01570907
Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions
NCT00827320
Bioequivalency Study of Perindopril Erbumine 8 mg Tablet Under Fed Conditions
NCT01013155
Bioequivalency Study of Perindopril Erbumine 8 mg Tablet Under Fasted Conditions
NCT01012687
Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Steady State Fasted Conditions
NCT01570959
Dose Proportionality and Food Effect of Morphine Sulfate
NCT00994539
Comparative Bioavailability Study of Morphine Sulfate Immediate Release and Controlled Release
NCT00994383
Bioequivalency Study of Protriptyline 10 mg Tablets Under Fasted Conditions
NCT00754962
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions
NCT01132716
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions
NCT01132729
Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions
NCT00992095
Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions
NCT01010139
Bioequivalency Study of Anastrozole 1 mg Under Fed Conditions
NCT01155089
Bioequivalency Study of Morphine Sulfate Injection, Solution and Tablet Under Fasted Conditions
NCT00994942
Bioequivalency Study of Anastrozole 1 mg Under Fasted Conditions
NCT01155102
Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fasted Conditions
NCT00894088
Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fed Conditions
NCT00893958
Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions
NCT00893919
Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasted Conditions
NCT00893542
Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting Conditions
NCT00826865
Phase Distribution
| Phase | Trial count |
|---|---|
| Phase 1 | 16 |
| Phase 3 | 1 |
| Phase 4 | 1 |
Therapeutic Areas
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.
Read our methodology - how this data is sourced, computed, and verified.
Related
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.