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.

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Tetraphase Announces Positive Top-line Results from Phase 3 IGNITE 1 Clinical Trial of Eravacycline in Complicated Intra-abdominal Infections

Posted 4 days ago in Clinical Trials

WATERTOWN, Mass., December 17, 2014--(BUSINESS WIRE)-- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced positive top-line results from IGNITE 1, the Company's Phase 3 clinical trial of eravacycline for the treatment of complicated intra-abdominal infection (cIAI)...

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Zafgen Announces Initiation of Phase 2b Trial of Beloranib in Severe Obesity

Posted 5 days ago in Clinical Trials

BOSTON, Dec. 15, 2014 (GLOBE NEWSWIRE) -- Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced that the Company has initiated a Phase 2b clinical trial with its lead product candidate, beloranib, in the treatment of patients with both severe obesity and type 2...

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Karyopharm Initiates Third Registration-Directed Clinical Trial of Oral Selinexor (KPT-330)

Posted 9 days ago in Clinical Trials

NEWTON, Mass., Dec. 11, 2014 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced the initiation of the SADAL study, (Selinexor and Dexamethasone in Aggressive Lymphoma), a registration-directed, Phase 2b study of Selinexor (KPT-330), in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This randomized, multi-center study of...

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Lakewood-Amedex Submits Investigational New Drug Application for Bisphosphocin™ Nu-3 for the Treatment of Diabetic Foot Infections

Posted 10 days ago in Clinical Trials

SARASOTA, Fla., Dec. 11, 2014 /PRNewswire/ -- Lakewood-Amedex Inc., a leading developer of novel anti-infective pharmaceuticals, announced that the Company has submitted an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to conduct a Phase 1/2a study of Nu-3 as a topical antimicrobial treatment for diabetic foot infections. Pending the FDA's acceptance, the Phase 1/2a is...

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Immuno-Oncology Clinical Collaboration Studying Opdivo (nivolumab) and Mogamulizumab in Advanced Solid Tumors Announced

Posted 11 days ago in Clinical Trials

TOKYO & OSAKA, Japan & NEW YORK, December 10, 2014--(BUSINESS WIRE)--Ono Pharmaceutical Co.,Ltd. (Tokyo: 4528), Bristol-Myers Squibb Company (NYSE:BMY) and Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151,“Kyowa Hakko Kirin”) announced today the companies have entered into a clinical trial collaboration agreement to conduct a Phase 1 combination study with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, and...

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Lilly And Incyte Announce Positive Top-Line Results From Phase 3 Trial Of Baricitinib In Moderate To Severe Rheumatoid Arthritis

Posted 12 days ago in Clinical Trials

INDIANAPOLIS, Dec. 9, 2014 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today announce that the Phase 3 RA-BEACON study of the investigational medicine baricitinib met its primary endpoint of improved ACR20 response compared to placebo after 12 weeks of treatment. The study included patients with moderately-to-severely active rheumatoid arthritis (RA) who previously failed...

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Mast Announces Plans For Development Of Vepoloxamer (MST-188) In Heart Failure

Posted 12 days ago in Clinical Trials

SAN DIEGO, Dec. 9, 2014 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage biopharmaceutical company, today provided details of its plan to develop vepoloxamer (MST-188), its lead product candidate, in heart failure. Consistent with prior guidance, earlier this year, Mast Therapeutics submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA),...

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Data From Phase 2 Clinical Trial of TG-1101 (Ublituximab) and Ibrutinib Shows Compelling Clinical Activity in CLL

Posted 13 days ago in Clinical Trials

SAN FRANCISCO, Dec. 8, 2014 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (Nasdaq:TGTX), today announced clinical results from its Phase 2 study of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody, in combination with ibrutinib (IMBRUVICA®), the oral BTK inhibitor from Pharmacyclics (Nasdaq:PCYC) and Janssen Biotech, Inc. Data from the Phase 2 study is being presented during the...

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Data from Phase 3 Study Evaluating Brivaracetam as Adjunctive Treatment of Partial-Onset Seizures

Posted 13 days ago in Clinical Trials

Brussels (Belgium), 8th December 2014 – 0700 (CET) – Today UCB announced the primary efficacy and safety data from the latest Phase 3 study evaluating brivaracetam (fixed doses of 100 and 200 mg/day with no up-titration) as adjunctive treatment in adult epilepsy patients with partial-onset seizures.1 This study with brivaracetam represents the largest Phase 3 study conducted in epilepsy patients with...

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Anticoagulant Effect of Eliquis (apixaban) Reversed by Two Separate 4-Factor Prothrombin Complex Concentrates in Healthy Subjects

Posted 13 days ago in Clinical Trials

PRINCETON, N.J. & NEW YORK, December 8, 2014 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced results of the first human study evaluating the reversal of the anticoagulant effect of Eliquis (apixaban) by 4-factor prothrombin complex concentrates (PCCs) in healthy subjects. The study results demonstrated that both PCCs, Sanquin’s Cofact (a heparin-free...

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New Data Show Idarucizumab Reverses Anticoagulant Effects of Dabigatran in Middle-Aged, Elderly and Renally Impaired Volunteers

Posted 13 days ago in Clinical Trials

Ridgefield, CT, December 8, 2014 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced phase I data that showed administration of investigational idarucizumab in healthy volunteers who were middle-aged (45 to 64 years) or elderly (65 to 80 years), or volunteers with mild or moderate kidney impairment, resulted in immediate, complete and sustained reversal of the anticoagulation effects of dabigatran...

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Takeda Presents Phase 2 Data on Maintenance with Single-Agent Investigational Ixazomib in Patients with Newly Diagnosed Multiple Myeloma

Posted 2 weeks ago in Clinical Trials

San Francisco, CA, December 7, 2014 and Osaka, Japan, December 8, 2014 – Takeda Pharmaceutical Company Limited (TSE:4502) today announced results from an open-label, Phase 2 study evaluating the safety and efficacy of oral, single-agent ixazomib (MLN9708) as maintenance therapy in patients with multiple myeloma (MM) who had received ixazomib, lenalidomide and dexamethasone as induction therapy. The data from this...

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Abbvie Presents Results From Phase 2 Study Of Investigational Compound Venetoclax (ABT-199/GDC-0199) In Acute Myelogenous Leukemia

Posted 2 weeks ago in Clinical Trials

NORTH CHICAGO, Ill., Dec. 7, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) presented during an oral presentation at the American Society of Hematology's 56th Annual Meeting new results from a Phase 2 study of investigational compound venetoclax (ABT-199/GDC-0199) in patients with acute myelogenous leukemia (AML). AML is an aggressive and deadly type of blood cancer, in which the body produces too many of a specific type...

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Novartis Highlights New CTL019 Clinical Data Showing Complete Remissions in Relapsed/Refractory Acute Lymphoblastic Leukemia

Posted 2 weeks ago in Clinical Trials

EAST HANOVER, N.J., Dec. 6, 2014 Findings from continued clinical studies of investigational chimeric antigen receptor (CAR) therapy, CTL019, demonstrate its potential role in the treatment of certain types of lymphocytic leukemia. In one long-term study of pediatric patients with acute lymphoblastic leukemia (ALL), results showed that 36 of 39 pediatric patients with relapsed/refractory (r/r) ALL, or 92%,...

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Takeda's Investigational, Oral Proteasome Inhibitor Ixazomib Granted Breakthrough Therapy Designation by FDA

Posted 2 weeks ago in Clinical Trials

Cambridge, Mass, December 1, 2014 and Osaka, Japan, December 2, 2014 – Takeda Pharmaceutical Company Limited (TSE:4502) today announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy status to the company’s investigational, oral proteasome inhibitor, ixazomib (MLN9708), for the treatment of relapsed or refractory systemic light-chain (AL) amyloidosis. This is the first proteasome...

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OncoMed Begins Patient Dosing in Phase 2 Clinical Trial of Tarextumab (Anti-Notch 2/3, OMP-59R5) in Small Cell Lung Cancer

Posted 2 weeks ago in Clinical Trials

REDWOOD CITY, Calif., Dec. 1, 2014 -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, announced that patient dosing has begun in the randomized, placebo-controlled Phase 2 portion of the company's "PINNACLE" clinical trial of its anti-Notch2/3 cancer stem cell antibody, tarextumab (OMP-59R5), for the...

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Eli Lilly And Company And AstraZeneca Initiate Pivotal Clinical Trial For Patients With Early Alzheimer's Disease

Posted 2 weeks ago in Clinical Trials

INDIANAPOLIS, Dec. 1, 2014 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and AstraZeneca today announced enrollment of the first patient into AMARANTH, a Phase II/III study of an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer's disease. AZD3293, also known as LY3314814, has been shown in Phase I studies to reduce levels of amyloid-beta in...

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Bristol-Myers Squibb Receives Complete Response Letter from FDA for Daclatasvir for Hepatitis C

Posted 3 weeks ago in Clinical Trials

PRINCETON, N.J., November 26, 2014 -- Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for daclatasvir, an NS5A complex inhibitor, in combination with other agents for the treatment of hepatitis C (HCV). The initial daclatasvir NDA submitted to the FDA focused on its use in...

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Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab

Posted 3 weeks ago in Clinical Trials

THOUSAND OAKS, Calif. and LONDON, Nov. 25, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and AstraZeneca (NYSE: AZN) today announced that AMAGINE-2TM, a pivotal, multi-arm Phase 3 trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, met its primary endpoints when compared with both Stelara® (ustekinumab) and placebo at week 12. Brodalumab 210 mg given every two...

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Avaxia Biologics Receives FDA Orphan Drug Designation for AVX-470 for Pediatric Ulcerative Colitis

Posted 3 weeks ago in Clinical Trials

LEXINGTON, Mass. – November 21, 2014 – Avaxia Biologics, Inc., a clinical stage biopharmaceutical company developing gut-targeted antibody therapeutics for gastrointestinal diseases, announced today that the US Food and Drug Administration (FDA) granted Orphan Drug Designation to AVX-470 for the treatment of pediatric ulcerative colitis. AVX-470 is a gut-targeted anti-TNF antibody, which earlier this year...

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