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Clinical Trial News

This section provides information about recently completed clinical trials. If you cannot find information about a particular clinical trial, you should note that results may not be available even after the trial ends. Some trials end before completion and results are never published.

Iterum Initiates SURE 2 and SURE 3 Phase 3 Clinical Trials of IV and Oral Sulopenem in Complicated Urinary Tract and Complicated Intra-abdominal Infections

Posted 4 days ago in Clinical Trials

DUBLIN, Ireland and CHICAGO, Sept. 18, 2018 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company developing antibiotics against multi-drug resistant pathogens, today announced its initiation of the second and third of three planned Phase 3 clinical trials for sulopenem, Iterum’s lead compound and novel antibiotic for the treatment of gram-negative, multi-drug resistant ... Read more...

Positive Barhemsys Phase 3 Treatment Data Published in Anesthesia & Analgesia

Posted 9 days ago in Clinical Trials

Cambridge, UK and Indianapolis, US – 14 September 2018: Acacia Pharma Group plc (“Acacia Pharma”, the “Company”) (EURONEXT: ACPH) announces that data and analyses from its positive Phase 3 clinical trial with Barhemsys (intravenous amisulpride) have been published in the online edition of the leading peer-reviewed journal Anesthesia & Analgesia (Candiotti et al1). Positive headline results were first announced by the... Read more...

AbbVie Presents Upadacitinib Longer-Term (32-Week) and Patient-Reported Outcomes Data from Phase 2b Atopic Dermatitis Study at 27th European Academy of Dermatology and Venereology (EADV) Congress

Posted 9 days ago in Clinical Trials

NORTH CHICAGO, Ill., Sept. 13, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new results from the ongoing Phase 2b study including longer-term (32-week) efficacy and safety data and patient-reported outcomes data evaluating upadacitinib, an investigational, once-daily oral JAK1-selective inhibitor, in adult patients with moderate to severe atopic... Read more...

AbbVie Announces Patient-Reported Outcomes Data from Three Pivotal Phase 3 Studies of Risankizumab, Showing Significant Improvements in Health-Related Quality of Life for Patients with Psoriasis

Posted 9 days ago in Clinical Trials

NORTH CHICAGO, Ill., Sept. 13, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new patient-reported outcomes data from three pivotal Phase 3 trials evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, in adult patients with moderate to severe plaque psoriasis. Across all three trials, patients reported significant improvements in... Read more...

Phase 2b STORM Data Evaluating Selinexor in Patients with Penta-Refractory Multiple Myeloma Presented at the Society of Hematologic Oncology 2018 Annual Meeting

Posted 10 days ago in Clinical Trials

NEWTON, Mass., Sept. 13, 2018 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that updated clinical data from the Phase 2b STORM (Selinexor Treatment of Refractory Myeloma) study evaluating selinexor, the Company’s lead, oral Selective Inhibitor of Nuclear Export (SINE) compound, in heavily pretreated patients with penta-refractory multiple m... Read more...

Bristol-Myers Squibb’s Novel, Oral, Selective TYK2 Inhibitor Delivered Significant Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis in Phase 2 Trial

Posted 11 days ago in Clinical Trials

PRINCETON, N.J.--(BUSINESS WIRE)-- September 12, 2018 -- Bristol-Myers Squibb Company (NYSE:BMY) today announced results from a Phase 2 study of BMS-986165, an investigational oral, selective tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate to severe plaque psoriasis. Efficacy endpoints including ≥75% and 90% reduction in the Psoriasis Area and Severity Index (PASI 75, PASI 90) were achieved following 1... Read more...

Theravance Biopharma and Mylan to Report New Data from Phase 3 Studies of Yupelri (revefenacin) in Oral Presentation at European Respiratory Society International Congress 2018

Posted 12 days ago in Clinical Trials

DUBLIN and HERTFORDSHIRE, England and PITTSBURGH, Sept. 11, 2018 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") and Mylan N.V. (NASDAQ: MYL) ("Mylan") today announced that new data from the Phase 3 Yupelri™ (revefenacin) inhalation solution clinical program will be featured in an oral presentation at the European Respiratory Society (ERS) International Congress 2018, being held in ... Read more...

Cyclacel Pharmaceuticals Announces Initiation of Phase 1b/2 Clinical Trial of Sapacitabine With Olaparib in BRCA Mutant Breast Cancer

Posted 12 days ago in Clinical Trials

BERKELEY HEIGHTS, N.J., Sept. 10, 2018 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC, Nasdaq:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer biology, announced the initiation of a Phase 1b/2 investigator-sponsored clinical trial to evaluate the safety and effectiveness of sapacitabine in combination with olaparib in patients with... Read more...

Amicus Therapeutics Announces Regulatory and Clinical Updates for AT-GAA in Pompe Disease

Posted 12 days ago in Clinical Trials

CRANBURY, N.J., Sept. 10, 2018 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), a global biotechnology company focused on discovering, developing and delivering novel medicines for rare metabolic diseases, announced today regulatory and clinical advancements in its development program AT-GAA for Pompe disease. During the third quarter, Amicus held a Type C meeting with the United States Food and Drug... Read more...

Argenx Doses First Patient in Global Phase 3 Registration Trial of Efgartigimod

Posted 2 weeks ago in Clinical Trials

September 06, 2018 -- Breda, the Netherlands / Ghent, Belgium – argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced the dosing of the first patient in a global Phase 3 registration trial of efgartigimod (ARGX-113) in patients with generalized m... Read more...

ContraFect Completes Enrollment in Phase 2 Clinical Trial Evaluating CF-301 (exebacase) in Patients with Staphylococcus Aureus Bacteremia

Posted 2 weeks ago in Clinical Trials

YONKERS, N.Y., Sept. 06, 2018 (GLOBE NEWSWIRE) -- ContraFect Corporation (Nasdaq:CFRX), a clinical-stage biotechnology company focused on the discovery and development of protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, today announced that it has completed enrollment in the Phase 2 clinical trial evaluating its first-in-class lysin, CF-301, as a potential treatment for... Read more...

Tezepelumab Granted Breakthrough Therapy Designation By US FDA For The Treatment Of Patients With Severe Asthma Without An Eosinophilic Phenotype

Posted 2 weeks ago in Clinical Trials

THOUSAND OAKS, Calif., Sept. 6, 2018 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype. A Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that are... Read more...

Gilead and Galapagos Announce TORTUGA Phase 2 Study of Filgotinib in Ankylosing Spondylitis Achieves Primary Endpoint

Posted 2 weeks ago in Clinical Trials

FOSTER CITY, Calif. & MECHELEN, Belgium--(BUSINESS WIRE)--Sep. 6, 2018-- Gilead Sciences, Inc. (NASDAQ:GILD) and Galapagos NV (Euronext & NASDAQ:GLPG) today announced that the randomized, placebo-controlled Phase 2 TORTUGA study of filgotinib, an investigational, selective JAK1 inhibitor, achieved its primary efficacy endpoint in adults with moderately to severely active ankylosing spondylitis (AS). In the study,... Read more...

Pfizer Receives Breakthrough Therapy Designation from FDA for PF-06651600, an oral JAK3 Inhibitor, for the Treatment of Patients with Alopecia Areata

Posted 2 weeks ago in Clinical Trials

September 5, 2018 - Pfizer Inc. (NYSE:PFE) today announced its investigational oral Janus kinase 3 (JAK3) inhibitor PF-06651600 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body.1,2 The Breakthrough Therapy designation for alopecia areata... Read more...

Lilly Announces Positive Phase 3 Results in Study of Flortaucipir PET Imaging Agent

Posted 2 weeks ago in Clinical Trials

INDIANAPOLIS, Sept. 5, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, today announced that a Phase 3 study of flortaucipir F 18, a Positron Emission Tomography (PET) imaging agent, met its two primary endpoints, defined as predicting brain tau pathology and predicting Alzheimer's disease diagnosis. The study, referred to as A16,... Read more...

FDA Approves Clinical Trial of Novel Treatment for Fibromyalgia

Posted 2 weeks ago in Clinical Trials

LOS ANGELES--(BUSINESS WIRE) September 05, 2018 --Today EpicGenetics announced that the U.S. Food and Drug Administration (FDA) has given approval to the Massachusetts General Hospital for a human clinical trial of BCG (an inexpensive generic vaccine used globally to prevent tuberculosis) to treat fibromyalgia. The trial is being funded by a philanthropic gift from Bruce Gillis, M.D., an advocate for fibromyalgia... Read more...

Biogen Enrolls First Patient in Global Phase 3 Study of BIIB093 (IV Glibenclamide) for Large Hemispheric Infarction

Posted 2 weeks ago in Clinical Trials

CAMBRIDGE, Mass., Sept. 04, 2018 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) announced today the enrollment of the first patient in the global Phase 3 clinical study CHARM, designed to evaluate BIIB093 (intravenous (IV) glibenclamide) for the prevention and treatment of severe cerebral edema in large hemispheric infarction (LHI), one of the most severe types of ischemic stroke where brain swelling (cerebral edema)... Read more...

Recro Pharma Provides Regulatory Update for IV Meloxicam

Posted 2 weeks ago in Clinical Trials

MALVERN, Pa., Sept. 04, 2018 (GLOBE NEWSWIRE) -- Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty pharmaceutical company focused on therapeutics for the hospital and other acute care settings, today provided a regulatory update following receipt of the official meeting minutes from a July 2018 Type A meeting with the U.S. Food and Drug Administration (FDA) relating to a path forward for intravenous... Read more...

CTD Holdings Discusses its Phase I Clinical Trial for Intravenous Use of Trappsol® Cyclo™ in Niemann-Pick Disease Type C

Posted 3 weeks ago in Clinical Trials

ALACHUA, Fla., Aug. 30, 2018 (GLOBE NEWSWIRE) -- CTD Holdings, Inc. (OTCQB: CTDH), a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, responds today to community queries on the status of its Phase I clinical trial for Trappsol(R) Cyclo(TM) for Niemann Pick Disease Type C (NPC), a rare and fatal genetic disease. “Since CTD’s par... Read more...

Pfizer Terminates Domagrozumab (PF-06252616) Clinical Studies for the Treatment of Duchenne Muscular Dystrophy

Posted 3 weeks ago in Clinical Trials

August 30, 2018 - Pfizer Inc. (NYSE: PFE) announced today that it is terminating two ongoing clinical studies evaluating domagrozumab (PF-06252616) for the treatment of Duchenne muscular dystrophy (DMD): a Phase 2 safety and efficacy study (B5161002) and an open-label extension study (B5161004). The Phase 2 study (B5161002), did not meet its primary efficacy endpoint, which was to demonstrate a difference in the... Read more...

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