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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.

Inventiva’s Phase IIb FASST Trial in Systemic Sclerosis with Lanifibranor Completes Enrollment

Posted 4 days ago in Clinical Trials

DAIX, France--(BUSINESS WIRE)-- October 17, 2017 Inventiva (Paris:IVA), a biopharmaceutical company developing innovative breakthrough therapies, particularly for the treatment of fibrotic diseases, today announced that it has completed the enrollment of its Phase IIb FASST (For A Systemic Sclerosis Treatment) trial in Systemic Sclerosis (SSc) with lanifibranor, formerly known as IVA337. FASST is progressing well...

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Incysus Announces FDA Approval of IND Application for a Phase I Study of a Gamma-Delta (γδ) T Cell Leukemia and Lymphoma Immunotherapy

Posted 6 days ago in Clinical Trials

NEW YORK, Oct. 17, 2017 (GLOBE NEWSWIRE) -- Incysus, Ltd., a biopharmaceutical company focused on delivering an innovative gamma-delta (γδ) T cell immunotherapy for the treatment of cancers, today announced that the U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for a Phase 1 study of leukemia and lymphoma immunotherapy. This marks the first expanded and activated a...

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TG Therapeutics Provides Update on FDA Meeting for TG-1101 (ublituximab) GENUINE Phase 3 Trial

Posted 7 days ago in Clinical Trials

NEW YORK, Oct. 16, 2017 (GLOBE NEWSWIRE) -- TG Therapeutics (NASDAQ:TGTX) announced today that it has met with the U.S. Food and Drug Administration (FDA) regarding the use of the results from the GENUINE Phase 3 trial to support a Biologics License Application (BLA) filing for approval of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody, in combination with ibrutinib. During...

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Pfizer Presents Full Results from Phase 2 Study of Next-Generation Investigational ALK-Inhibitor Lorlatinib in ALK-Positive and ROS1-Positive Advanced Non-Small Cell Lung Cancer

Posted 7 days ago in Clinical Trials

October 16, 2017 - Pfizer Inc. (NYSE:PFE) today announced full results from the Phase 2 clinical trial of the investigational, next-generation tyrosine kinase inhibitor lorlatinib that exhibited clinically meaningful activity against lung tumors and brain metastases in a range of patients with ALK-positive and ROS1-positive advanced non-small cell lung cancer (NSCLC), including those who were heavily pretreated....

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Ardelyx's Pivotal Phase 3 Study of Tenapanor for IBS-C Hits Primary and All Secondary Endpoints to Support NDA Submission in 2018

Posted 12 days ago in Clinical Trials

FREMONT, Calif., Oct. 11, 2017 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ: ARDX) today reported positive results from T3MPO-2, its second Phase 3 study of tenapanor for irritable bowel syndrome with constipation (IBS-C). The study hit statistical significance for the primary endpoint and all secondary endpoints evaluated for the topline results and demonstrated the ability to normalize bowel movements. The primary...

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Merck Provides Update on Anacetrapib Development Program

Posted 12 days ago in Clinical Trials

KENILWORTH, N.J.--(BUSINESS WIRE) October 11, 2017 --Merck (NYSE: MRK), known as MSD outside the U.S. and Canada, today announced that the company will not submit applications for regulatory approval for anacetrapib, Merck’s investigational cholesteryl ester transfer protein (CETP) inhibitor. The decision follows a thorough review of the clinical profile of anacetrapib, including discussions with external e...

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FDA Grants Fast Track Designation to Astellas for Development of Gilteritinib in Relapsed or Refractory Acute Myeloid Leukemia

Posted 13 days ago in Clinical Trials

TOKYO, Oct. 10, 2017 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of gilteritinib for adult patients with FLT3 mutation-positive (FLT3+) relapsed or refractory acute myeloid leukemia (AML). Fast Track designation is designed to facilitate the...

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Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide From Boosted Protease Inhibitor-Based Regimens

Posted 2 weeks ago in Clinical Trials

FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 4, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced detailed 48-week results from a Phase 3 study (Study 1878) evaluating the efficacy and safety of switching virologically suppressed HIV-1 infected adult patients from a multi-tablet regimen containing a boosted protease inhibitor (bPI) to a fixed-dose combination of bictegravir (50 mg) (BIC), a novel...

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Zogenix Announces Positive Top-line Results from Pivotal Phase 3 Clinical Trial of ZX008 in Dravet Syndrome

Posted 3 weeks ago in Clinical Trials

EMERYVILLE, Calif., Sept. 29, 2017 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, today reported positive top-line results from its first Phase 3 trial (Study 1) for its investigational drug, ZX008 (low-dose fenfluramine hydrochloride), for the treatment of Dravet syndrome. The trial met its primary...

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Cascadian Therapeutics Announces FDA Orphan Drug Designation Granted to Tucatinib for the Treatment of HER2+ Metastatic Colorectal Cancer

Posted 3 weeks ago in Clinical Trials

SEATTLE, Sept. 27, 2017 (GLOBE NEWSWIRE) -- Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration ("FDA") has granted orphan drug designation to tucatinib for the treatment of HER2-positive (HER2+) metastatic colorectal cancer. Tucatinib is an investigational oral, small molecule kinase inhibitor that is highly selective for...

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Axovant Announces Negative Topline Results of Intepirdine Phase 3 MINDSET Trial in Alzheimer's Disease

Posted 3 weeks ago in Clinical Trials

BASEL, Switzerland, Sept. 26, 2017 /PRNewswire/ -- Axovant Sciences (NASDAQ: AXON) today announced that the Phase 3 MINDSET clinical trial of its investigational drug intepirdine in patients with mild to moderate Alzheimer's disease (AD) who were receiving background donepezil therapy did not meet its co-primary efficacy endpoints. At 24 weeks, patients treated with 35 mg of intepirdine did not experience...

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Acer Therapeutics Reports Positive Results From Pivotal Clinical Trial of Edsivo (celiprolol) for Treatment of Vascular Ehlers-Danlos Syndrome

Posted 4 weeks ago in Clinical Trials

Cambridge, MA – September 25, 2017 -- Acer Therapeutics Inc., (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and ultra-rare diseases with critical unmet medical need, today announced positive results from the pivotal clinical trial of Edsivo™ (celiprolol) for the treatment of vascular Ehlers-Danlos Syndrome (vEDS). Acer’s retro...

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Arbutus Announces Topline Results for ARB-1467 Phase II Cohort 4

Posted 4 weeks ago in Clinical Trials

VANCOUVER, British Columbia and WARMINSTER, Pa., Sept. 25, 2017 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, announced topline results of the bi-weekly dosing segment of Cohort 4 of the Phase II study of its RNAi agent, ARB-1467. In the bi-weekly dosing segment of Cohort 4, twelve HBeAg negative chronically infected...

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Sanofi and Alnylam Report Positive Topline Results from APOLLO Phase 3 Study of Patisiran in Hereditary ATTR (hATTR) Amyloidosis Patients with Polyneuropathy

Posted 4 weeks ago in Clinical Trials

Paris, France and Cambridge, MA - September 20, 2017 - Sanofi Genzyme, the specialty care global business unit of Sanofi, and Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company announced today that the APOLLO Phase 3 study of patisiran, an investigational RNAi therapeutic being developed for patients with hereditary ATTR amyloidosis with polyneuropathy, met its primary efficacy...

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Nabriva Therapeutics Announces Positive Topline Results from Global, Phase 3 Clinical Trial Evaluating IV and Oral Lefamulin for the Treatment of Community-Acquired Bacterial Pneumonia

Posted 5 weeks ago in Clinical Trials

DUBLIN, Ireland and KING OF PRUSSIA, Pa., Sept. 18, 2017 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ:NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics, today announced positive topline results from the lefamulin evaluation against pneumonia (LEAP 1)...

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Biohaven And Alzheimer’s Disease Cooperative Study (ADCS) Announce Phase 2 Clinical Trial Collaboration Evaluating Glutamate Modulating Agent Trigriluzole In Patients With Mild-to-moderate Alzheimer’s Disease

Posted 5 weeks ago in Clinical Trials

New Haven, Connecticut (NYSE: BHVN) September 15, 2017 – Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, announced today its clinical trial collaboration with the Alzheimer’s Disease Cooperative Study (ADCS). The ADCS is a leading Alzheimer’s disease (AD) clinical trial...

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Mirati Therapeutics Presents Positive Preliminary Data From On-Going Clinical Trials Of Sitravatinib In Non-Small Cell Lung Cancer

Posted 5 weeks ago in Clinical Trials

SAN DIEGO, Sept. 14, 2017 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology biotechnology company, announced that positive preliminary data from two ongoing clinical trials of sitravatinib in non-small cell lung cancer (NSCLC) will be presented Friday, September 15th, 2017 at the IASLC 2017 Chicago Multidisciplinary Symposium in Thoracic Oncology (learn more at...

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Tetraphase Pharmaceuticals Completes Enrollment of IGNITE3 Phase 3 Clinical Trial of Eravacycline in Complicated Urinary Tract Infections

Posted 5 weeks ago in Clinical Trials

WATERTOWN, Mass., Sept. 11, 2017 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced completion of enrollment in IGNITE3, its ongoing phase 3 clinical trial evaluating the efficacy and safety of once-daily intravenous (IV) eravacycline compared to...

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AbbVie's Upadacitinib (ABT-494) Meets All Primary and Ranked Secondary Endpoints in Second Phase 3 Study in Rheumatoid Arthritis

Posted 6 weeks ago in Clinical Trials

NORTH CHICAGO, Ill., Sept. 11, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-BEYOND clinical trial evaluating upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, in patients with moderate to severe rheumatoid arthritis (RA) who did not adequately respond or were...

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Evenity (romosozumab) ARCH Study Results Published In The New England Journal Of Medicine

Posted 6 weeks ago in Clinical Trials

THOUSAND OAKS, Calif. and BRUSSELS, Sept. 11, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced detailed results from the Phase 3 ARCH study showing that 12 months of Evenity™* (romosozumab) followed by alendronate was superior in reducing new vertebral, clinical, non-vertebral and hip fracture risk in postmenopausal women with osteoporosis at high risk for fracture, compared t...

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