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Clinical trials
catalyst calendar across sponsors →Studies where AMRX is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
12 interventional · 1 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Updated |
|---|---|---|---|---|---|---|---|
| A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both EyesNCT06267274Primary EndpointRandomized · Triple-masked · Treatment | Phase 1 | Recruiting | Drug: Bimatoprost Ophthalmic Solution, 0.01%, LUMIGAN® (bimatoprost ophthalmic solution) 0.01% | Open-angle Glaucoma, Ocular Hypertension | 240 | 2025-03-01 | 2024-08-06 |
| Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes.NCT05401357Mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups.Randomized · Single-masked · Treatment | Phase 3 | Recruiting | Drug: Test - Bimatoprost 0.01% Ophthalmic Solution, Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution) | Glaucoma, Open-Angle, Ocular Hypertension | 168 | Dec 2022 | 2022-08-10 |
| SAD Study to Evaluate Safety, Tolerability, and Pharmacokinetic Profile of AMN1126 in Healthy Post-Menopausal FemalesNCT06467201Type, incidence, severity, seriousness, and relatedness of Adverse Events (AEs)Non-randomized · Open-label · Basic science | Phase 1 | Completed | Drug: KSHN001126 150mg, KSHN001126 300mg, KSHN001126 600mg | Healthy Postmenopausal Women | 18 | 2024-12-08actual | 2026-02-19 |
| BE Study in Patients - Methotrexate TabletsNCT02940561Area Under the Curve (AUC0-12)Randomized · Open-label | Phase 1 | Unknown status | Drug: Methotrexate - Amneal, Methotrexate - DAVA | Psoriasis, Rheumatoid Arthritis | 48 | Oct 2016 | 2016-10-21 |
| Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the KneeNCT02121002results2021-06-16Change From Baseline to 4 Weeks in WOMAC Pain ScoreRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Diclofenac Sodium Topical Gel, 1%, Voltaren Topical Gel, 1%, Vehicle Diclofenac Sodium Topical Gel | Osteoarthritis | 1,176 | Oct 2014actual | 2021-06-16 |
| Comparative Bioequivalence Study in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed ConditionsNCT02103322CmaxRandomized · Open-label · Treatment | Phase 2/3 | Completed | Drug: Imatinib Mesylate Tablets, 400 mg, Imatinib Mesylate Tablets, 400 mg | Chronic Myeloid Leukemia, Gastrointestinal Stromal Tumor | 48 | Mar 2014actual | 2014-06-27 |
| Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting ConditionsNCT02110368AUC0-tRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Testosterone Topical Gel, 1.62% Metered Pump, AndroGel (testosterone gel) 1.62% Metered-Dose Pump | Primary Hypogonadism, Hypogonadotropic Hypogonadism | 32 | Mar 2014actual | 2014-06-26 |
| Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg With Nasonex Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic RhinitisNCT02125253Change from Baseline rTNSSRandomized · Single-masked · Treatment | Phase 3 | Completed | Drug: Mometasone Furoate Nasal Spray, 50 mcg, Nasonex Nasal Spray, 50 mcg, Placebo Nasal Spray | Seasonal Allergic Rhinitis | 811 | Mar 2014actual | 2015-11-02 |
| Bioequivalence Fasting Study in PatientsNCT02072954AUC 0-tauRandomized · Open-label · Treatment | Phase 2/3 | Completed | Drug: Asenapine Sublingual Tablets 10 mg, Asenapine Sublingual Tablets 10 mg | Schizophrenia | 48 | Feb 2014actual | 2014-06-27 |
| Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as an Analgesic for Short-Term Treatment in Female Subjects Suffering From Moderate-to-Severe Pain and Burning Upon Urination Associated With Uncomplicated Urinary Tract Infections (uUTI)NCT01650051Self-assessmentsRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg, Phenazopyridine Hydrochloride Tables, USP 200 mg | Uncomplicated Urinary Tract Infections | 424 | Feb 2013actual | 2014-06-26 |
| Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to PlaceboNCT01779947RespondersRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Estradiol Vaginal Tablets 10 mcg, placebo | Atrophic Vaginitis Due to Menopause | 519 | Sep 2012actual | 2014-06-26 |
| Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. PlaceboNCT01064024proportion of subjects in each treatment group who demonstrate reduction in pain or burning when passing urine.Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Phenazopyridine Hydrochloride, Placebo | Pain, Urinary Tract Infections | 233 | Dec 2010actual | 2013-01-29 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19