Roxane Laboratories

Closed portfolio with an early-phase archive tilt

According to ClinicalTrials.gov-derived indexes, Roxane Laboratories sits in the top decile of US sponsors by registered trial count (#253 of 15,742 sponsors by registered trial count).

93 total trials none currently recruiting 92 completed early-phase tilt top decile by trial count

Roxane Laboratories: 93 sponsored US clinical trials, none currently recruiting.

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.

Top-decile sponsor footprint

Roxane Laboratories ranks in the top decile of sponsors by registered trial count (#253 of 15,742 sponsors by registered trial count). Volume at this scale usually reflects a long institutional pipeline, read phase tilt and therapeutic areas below before treating it as current-year activity.

Trial completion reliability score

B 87/100

92 of 93 decided trials (Completed vs. Terminated on ClinicalTrials.gov) reached their planned completion (98.9%), vs. national p10 68.4% / p90 100% among 1,234 sponsors with at least 10 decided trials. Still-open trials (Recruiting, Active-not-recruiting, Not-yet-recruiting) are excluded since they have not reached an outcome yet.

Indexed trials (enrollment closed)

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
Page 1 of 2 Next →

Phase Distribution

PhaseTrial count
Phase 1 16
Phase 3 1
Phase 4 1

Therapeutic Areas

Breast Cancer 4
Hypertension 3
Bipolar Disorder 3
Onychomycosis 2
Dry Mouth 2
Asthma 2
Inflammation 2
Chronic Stable Angina 1
Opioid-Related Disorders 1
Vasospastic Angina 1

How the Roxane Laboratories early-phase archive is shaped

93 indexed studies, none listed as recruiting (0% open); 92 completed (99%).

Phase mix: 2 late (III/IV) vs 16 early (I/II) (early-phase heavy).

Top condition: Breast Cancer (4 trials), 9 others listed.

How to read a closed sponsor archive

When recruiting_count is zero, the indexed set is completed or otherwise not open. Phase tilt still describes where archived studies sat on the investigational pathway. Re-check ClinicalTrials.gov before acting.

Roxane Laboratories: archived-pipeline peers nationwide

Peers matched on 93 indexed studies with no current recruiting: volume and archive shape, not condition overlap.

Roxane Laboratories sits at or above the median trial volume and at or above the median recruiting share among these 9 nationwide peers -- the two do not always move together. Source: ClinicalTrials.gov (2026-08-08 snapshot). 2×2 strategic matrix plotting 9 entities by Total trials (X) and Recruiting share (Y), with a crosshair dividing the plot into four quadrants. Higher volume & more openFocused & more openHigher volume, mostly closedSmaller & mostly closed 020406080100 0%5%10%15%20%25% Total trials Recruiting share Roxane LaboratoriesNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)National Institute on Alcohol Abuse and Alcoholism (NIAAA)Colorado State UniversityEndeavor Health10xBio22nd Century Group23andMe3-C Institute for Social Development
Roxane Laboratories sits at or above the median trial volume and at or above the median recruiting share among these 9 nationwide peers -- the two do not always move together. Source: ClinicalTrials.gov (2026-08-08 snapshot).

Roxane Laboratories sits at or above the median trial volume and at or above the median recruiting share among these 9 nationwide peers -- the two do not always move together.

Sponsors near 93 archived trials

Sponsors with similar archive density (± trial count)

Related

Read our methodology - how this data is sourced, computed, and verified.

What to do with this Roxane Laboratories page

93 registered trials is a research-attention snapshot, not an endorsement of Roxane Laboratories or any single study.

  • None of Roxane Laboratories's trials are currently recruiting in this registry; that can change as new trials post, or check the broader research index. Browse research indexes
  • Breast Cancer is the condition Roxane Laboratories studies most, compare against other sponsors active in the same condition before evaluating a specific study. See Breast Cancer trials
  • Bring the specific trial ID (NCT number) to your own doctor before enrolling, this page is a directory, not medical guidance. Read the trial-finding guide

Trial and recruiting counts reflect ClinicalTrials.gov registry status as of the data vintage above; individual trial eligibility and enrollment status can change.

Roxane Laboratories pipeline card: 93 registered trials from official public datasets.Report a data error.