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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.

Lilly's Galcanezumab Meets Primary Endpoint in Phase 3 Study Evaluating Galcanezumab for the Prevention of Episodic Cluster Headache

Posted 13 days ago in Clinical Trials

INDIANAPOLIS, May 15, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that galcanezumab met its primary endpoint in a Phase 3 study of patients with episodic cluster headache, demonstrating statistically significant differences in the reduction of weekly cluster headache attacks compared to placebo across weeks one to three of the two-month, double-blind treatment period. A statistically... Read more...

MediciNova Announces Opening of Investigational New Drug Application for MN-166 (ibudilast) in Glioblastoma

Posted 2 weeks ago in Clinical Trials

LA JOLLA, Calif., May 09, 2018 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that the Investigational New Drug Application (IND) for MN-166 (ibudilast) for treatment of glioblastoma (GBM) has been accepted and is now open with the U.S. Food and Drug Administration... Read more...

Daiichi Sankyo Announces Single Agent Quizartinib Significantly Prolongs Overall Survival Compared with Chemotherapy in Patients with Relapsed/Refractory AML with FLT3-ITD Mutations (QuANTUM-R Study)

Posted 2 weeks ago in Clinical Trials

Tokyo, Munich, and Basking Ridge, NJ – (May 8, 2018) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announces that the pivotal QuANTUM-R phase 3 study of single agent quizartinib met its primary endpoint of significantly prolonging overall survival compared to salvage chemotherapy in patients with relapsed/refractory acute myeloid leukemia (AML) with FLT3-ITD mutations after first-line treatment with o... Read more...

miRagen Therapeutics Announces New Interim Data From Phase 1 Clinical Trial Of Cobomarsen In Mycosis Fungoides

Posted 2 weeks ago in Clinical Trials

BOULDER, Colo., May 08, 2018 (GLOBE NEWSWIRE) -- miRagen Therapeutics, Inc. (NASDAQ:MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, announced new interim data from its Phase 1 clinical trial of cobomarsen in patients with the mycosis fungoides (MF) form of cutaneous T-cell lymphoma (CTCL). The data will be presented May 9, 2018, at the “2015... 2... Read more...

New Phase 3 Data Show Esketamine Nasal Spray Demonstrated Rapid Improvements in Depressive Symptoms in Patients with Treatment-Resistant Depression

Posted 3 weeks ago in Clinical Trials

TITUSVILLE, N.J., May 5, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the results from two Phase 3 clinical studies of the investigational compound esketamine nasal spray in patients with treatment-resistant depression. These studies will be presented at the American Psychiatric Association Annual Meeting, taking place May 5-9 in New York, NY. Data from a study in adults with t... Read more...

Alnylam Achieves Alignment with FDA on Accelerated Development Path for Lumasiran, an Investigational RNAi Therapeutic for the Treatment of Primary Hyperoxaluria Type 1 (PH1)

Posted 3 weeks ago in Clinical Trials

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 3, 2018-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the Company has reached alignment with the U.S. Food and Drug Administration (FDA) on a pivotal study design for lumasiran, an investigational RNAi therapeutic for the treatment of primary hyperoxaluria type 1 (PH1). The Company and the FDA have aligned on a... Read more...

Aldeyra Therapeutics Presents Dry Eye Disease Phase 2a Clinical Trial Results for Reproxalap at the Association for Research in Vision and Ophthalmology 2018 Annual Meeting

Posted 3 weeks ago in Clinical Trials

LEXINGTON, Mass., May 1, 2018 /PRNewswire/ -- Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company devoted to development of next-generation medicines to improve the lives of patients with immune-mediated diseases, presented the results of a randomized, double-masked, parallel-group Phase 2a dry eye disease clinical trial of topical ocular reproxalap at the Association for Research in Vision... Read more...

Motif Bio REVIVE-2 Phase 3 Study Results with Iclaprim Published in Peer-reviewed Journal, Antimicrobial Agents and Chemotherapy

Posted 3 weeks ago in Clinical Trials

NEW YORK, May 01, 2018 (GLOBE NEWSWIRE) -- Motif Bio plc (AIM:MTFB) (NASDAQ:MTFB), a clinical stage biopharmaceutical company specialising in developing novel antibiotics, today announced that the results from REVIVE-2, a global Phase 3 clinical trial evaluating the investigational drug candidate iclaprim in patients with acute bacterial skin and skin structure infections (ABSSSI), have been published in the... Read more...

New Novartis Phase III data for Brolucizumab Demonstrate Reliability of 12-week Treatment Interval

Posted 4 weeks ago in Clinical Trials

Basel, April 30, 2018 - Novartis announced new positive brolucizumab (RTH258) data in neovascular age-related macular degeneration (nAMD) from a pre-specified secondary analysis of the Phase III HAWK and HARRIER trials. The findings showed that patients assessed as appropriate for a 12-week treatment frequency during the first 12-week cycle after loading could reliably stay on that quarterly interval through week... Read more...

Karyopharm Announces Positive Top-Line Data from Phase 2b STORM Study Evaluating Selinexor in Patients with Penta-Refractory Multiple Myeloma

Posted 4 weeks ago in Clinical Trials

NEWTON, Mass., April 30, 2018 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today reported positive top-line results from the Phase 2b STORM study evaluating the Company’s lead, oral Selective Inhibitor of Nuclear Export (SINE) compound selinexor in heavily pretreated patients with refractory multiple myeloma. Regarding the STORM study’s primary objective, o... Read more...

Allergan Announces Second Positive Phase 3 Clinical Trial for Ubrogepant -- an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine

Posted 4 weeks ago in Clinical Trials

DUBLIN, April 27, 2018 /PRNewswire/ -- Allergan plc, (NYSE: AGN), a leading global pharmaceutical company today announced positive results from ACHIEVE II (UBR-MD-02), the second of two pivotal Phase 3 clinical trials evaluating the efficacy, safety and tolerability of orally administered ubrogepant 25 mg and ubrogepant 50 mg compared to placebo in a single migraine attack in adults. Allergan anticipates filing of a... Read more...

AAN 2018: Lilly's Galcanezumab Significantly Reduced Monthly Migraine Headache Days in Patients with Migraine Who Previously Failed to Respond to Multiple Preventive Therapies

Posted 4 weeks ago in Clinical Trials

INDIANAPOLIS, April 24, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today results from a post-hoc subgroup analysis which demonstrated efficacy of galcanezumab in patients with episodic and chronic migraine who previously failed to respond to two or more preventive therapies. Detailed results from a new subgroup analysis of three Phase 3 studies (EVOLVE-1, EVOLVE-2 and REGAIN) evaluating... Read more...

Synthetic Biologics Provides Update on Development of SYN-004 (ribaxamase), for the Prevention of C. difficile Infection

Posted 5 weeks ago in Clinical Trials

ROCKVILLE, Md., April 23, 2018 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE American: SYN), a late-stage clinical company developing therapeutics designed to preserve the microbiome to protect and restore the health of patients, today announced that it has preliminary agreement from the U.S. Food & Drug Administration (FDA), on a proposed clinical trial synopsis for its planned Phase 3 clinical trial for SYN-004... Read more...

Pivotal Phase 3 Study of Merck’s Investigational Beta-Lactamase Inhibitor Relebactam in Combination with Imipenem/Cilastatin Demonstrated Favorable Overall Response Against Certain Imipenem–Non-Susceptible Bacterial Infections

Posted 5 weeks ago in Clinical Trials

KENILWORTH, N.J., April 22, 2018 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that a pivotal Phase 3 study of relebactam, the company’s investigational beta-lactamase inhibitor, in combination with imipenem/cilastatin, demonstrated a favorable overall response in the treatment of certain imipenem–non-susceptible bacterial infections, the primary endpoint, with lower treat... Read more...

Clementia Initiates Phase 2 MO-Ped Trial for Palovarotene in Patients with Multiple Osteochondromas

Posted 5 weeks ago in Clinical Trials

MONTREAL, April 20, 2018 (GLOBE NEWSWIRE) -- Clementia Pharmaceuticals Inc. (NASDAQ:CMTA), a clinical-stage company innovating new treatments for people with ultra-rare bone disorders and other diseases, today announced the start of the MO-Ped Trial, its Phase 2 study evaluating the safety and efficacy of palovarotene for the treatment of pediatric patients with multiple osteochondromas (MO), also known as multiple... Read more...

New Novartis Analyses at AAN show Siponimod's Efficacy on Disability and Cognition in Secondary Progressive MS Patients

Posted 5 weeks ago in Clinical Trials

Basel, April 20, 2018 - Novartis today announced new analyses from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in patients with secondary progressive multiple sclerosis (SPMS). In pre-specified statistical analyses, treatment with siponimod consistently reduced the risk of confirmed disability progression in SPMS patients, with and without relapses[1]. In addition, new post-hoc analyses using... Read more...

Summit Completes Dosing of Ezutromid in PhaseOut DMD Clinical Trial

Posted 5 weeks ago in Clinical Trials

OXFORD, United Kingdom and CAMBRIDGE, Mass., April 19, 2018 (GLOBE NEWSWIRE) -- Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM) announces the completion of ezutromid dosing in patients with Duchenne muscular dystrophy (‘DMD’) for the full 48-week PhaseOut DMD clinical trial. Top-line data from the full trial continue to be expected in the third quarter of 2018. “We believe the early improvements seen in muscle he... Read more...

Merck Announces First Phase Three Studies for PCV-15 (V114) Its Investigational Pneumococcal Disease Vaccine

Posted 5 weeks ago in Clinical Trials

KENILWORTH, N.J.-- April 17, 2018 (BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the company is beginning two Phase 3 studies of PCV-15 (V114), its investigational polyvalent conjugate vaccine for the prevention of pneumococcal disease. The first study (ClinicalTrials.gov, NCT03480763) will evaluate the safety, tolerability and immunogenicity of PCV-15... Read more...

Amgen Presents First-Of-Its-Kind Data At AAN Annual Meeting Reinforcing Robust And Consistent Efficacy Of Aimovig (erenumab) For Migraine Patients With Multiple Treatment Failures

Posted 5 weeks ago in Clinical Trials

THOUSAND OAKS, Calif., April 17, 2018 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced full results from the Phase 3b LIBERTY trial of Aimovig™ (erenumab) in episodic migraine patients who had previously failed two to four preventive treatments, due to lack of efficacy or to intolerable side effects.1 The data, which will be presented at the 70th Annual Meeting of the American Academy of Neurology (AAN) in Los A... Read more...

Newly Published Phase 2 Study Found Esketamine Demonstrated Significantly Rapid Improvements in Depressive Symptoms and Suicidality

Posted 6 weeks ago in Clinical Trials

TITUSVILLE, N.J., April 16, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that data from a Phase 2 proof of concept clinical study of esketamine nasal spray, published in the American Journal of Psychiatry, showed that treatment with esketamine resulted in a statistically significant, clinically meaningful improvement in depressive symptoms at four hours, including a measure of s... Read more...

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