Clinical Trials
2580
297 active
Approvals
4
Total approvals
Agencies
1
Regulatory bodies
Founded
1811
Terminated
212
8.2%
Recruiting
333
12.9%
Suspended
8
0.3%
Withdrawn
157
6.1%
Active, not recruiting
174
6.7%
Unknown
146
5.7%
Completed
1427
55.3%
Enrolling By Invitation
24
0.9%
Not yet recruiting
99
3.8%
- AptarGroup and Massachusetts General Hospital signed a research collaboration to build an integrated translational platform for nose-to-brain drug delivery. - The platform will combine in vitro, in vivo and computational methods to characterize transport mechanisms, pathways and kinetics across molecular classes. - The intended output is a New Approach Methodology (NAM) aligned with FDA support for human-relevant in vitro and in silico drug development tools. - The work is led by Alice Stanton, PhD, and will incorporate Aptar's Cerespray and Neurospray nasal delivery platforms backed by 30 years of field data.
- The FDA has cleared Quantum BioPharma's Investigational New Drug application for Lucid-MS, allowing a randomized, double-blind, placebo-controlled Phase 2 trial in multiple sclerosis. - Lucid-MS is a patented, first-in-class non-covalent inhibitor of peptidyl arginine deiminase 2 (PAD2) designed to target demyelination rather than broadly suppress the immune system. - Preclinical models showed Lucid-MS prevented and reversed myelin degradation, and the Phase 2 study will assess safety, tolerability and potential therapeutic effects in patients with MS. - Quantum BioPharma is also collaborating with Massachusetts General Hospital and Harvard Medical School on the [18F]3F4AP PET tracer to visualize and measure demyelination.
- Hereditary angioedema treatment goals have shifted from reducing attack frequency to achieving complete freedom from attacks with better quality of life. - Experts identify breakthrough attacks, severe or throat swelling, and life disruptions as signals to reassess preventive therapy in HAE. - Pregnancy and hormonal contraception require early HAE care team involvement, as estrogen is a known trigger and danazol is contraindicated. - Bradykinin-driven swelling in HAE does not respond to antihistamines, corticosteroids, or epinephrine, requiring specialized prescription medications.
- The FDA has allowed an Investigational New Drug (IND) application to proceed for the first-ever U.S. clinical trial of an experimental gene therapy for Mucolipidosis Type IV (MLIV), an ultra-rare inherited neurological disease affecting fewer than 100 known children worldwide. - The investigational therapy uses an AAV9 vector to deliver a functional copy of the MCOLN1 gene, aiming to restore production of the deficient mucolipin-1 protein that drives the disease. - The milestone culminates nearly a decade of Foundation-coordinated research, including preclinical work at Massachusetts General Hospital and the University of Massachusetts Gene Therapy Center. - The ML4 Foundation hopes the first children will be treated in 2026, though clinical benefit, safety, and response variability remain unknown ahead of first-in-human dosing.
- Canada announced the hiring of 64 scholars supported by more than C$500 million ($350 million) over eight years through its Global Impact+ Research Talent Initiative. - Forty-eight of the recruited academics come from US institutions including Harvard, Cornell, and MIT, spanning medicine, engineering, and climate science. - Researchers cited frozen federal grants and concerns over academic freedom under the Trump administration as key factors driving their departure. - The initiative is part of a C$1.7 billion ($1.2 billion) effort to attract world-leading researchers to Canadian universities.
- NuVasc, a University of Alabama at Birmingham startup, is developing a liquid biopsy that detects the genetic driver mutations underlying brain arteriovenous malformations during routine endovascular procedures. - Three-quarters of sporadic bAVMs are driven by activating mutations in the KRAS or BRAF genes, alterations already established as drug targets in cancer. - The diagnostic approach was developed by Andrew T. Hale, M.D., Ph.D., in collaboration with Kristopher T. Kahle, M.D., Ph.D., of Massachusetts General Hospital, and is exclusively licensed to NuVasc. - The company is in an early translational stage, aiming to connect molecular diagnosis directly to targeted therapy for a disease with high unmet need and no targeted options today.
- Lindsay Clancy, a former labor-and-delivery nurse, is on trial for killing her three children, with her defense arguing she suffered from postpartum psychosis exacerbated by overmedication with 13 psychiatric drugs. - Postpartum psychosis is a psychiatric emergency that can present with delusions, hallucinations, and paranoia, yet it lacks a formal standalone diagnosis and universal screening in the U.S. - The case highlights systemic failures including fragmented care without a coordinating provider, chronic underfunding of women's health research, and severe shortages of perinatal mental health specialists. - Experts and advocates argue that without confronting the broken postpartum care infrastructure, preventable crises and tragedies will continue to occur.
- SKNV has licensed a Washington University patent portfolio covering the fluorouracil-calcipotriene combination therapy for actinic keratosis, moving academic immunotherapy research into commercial practice through the compounding market. - The American Academy of Dermatology has updated its guidance to favor field-directed therapy over lesion-by-lesion treatment, with the combination central to this shift due to its potential to reduce progression to squamous cell carcinoma. - Published data in the Journal of Clinical Investigation showed the combination reduced AK lesion counts after just four days of treatment, compared to the two-to-four-week course required for fluorouracil monotherapy. - A follow-up study tracking patients for over 1,500 days linked the short-course combination therapy to reduced squamous cell carcinoma incidence, an effect associated with persistence of tissue-resident memory T cells.
- Researchers have uncovered how Epstein-Barr virus (EBV) launches CD4+ T cell-driven immune responses that lead to inflammation and nervous system damage in multiple sclerosis. - The study, published in Science Translational Medicine, found that immune T cell activity was twice as high in people with MS compared to healthy controls, with CD4+ T cells driving the response. - Anti-CD20 therapies reduced CD4+ T cell levels by approximately 2.5 times and lowered EBV levels in saliva, while the MS drug frexalimab blocks CD4+ T-cell activity to reduce inflammation. - The findings could accelerate development of EBV vaccines or antiviral medications to prevent or manage MS without the major side effects of current immunosuppressants.
- ADLM 2026 convenes July 26–30 in Anaheim, California, bringing together nearly 17,000 global leaders in clinical laboratory medicine. - Dr. David M. Nathan will open the meeting reflecting on five decades of diabetes research, including his pioneering work establishing hemoglobin A1c as the gold-standard test and the role of GLP-1 in glucose regulation. - Dr. Elizabeth Head will present her 25-year investigation into the Alzheimer's–Down syndrome connection, exploring intervention targets that may inform precision medicine for the broader aging population. - Dr. Arun Wiita will close the conference with mass spectrometry-based discovery of novel cancer biomarkers on blood cancer cell membranes, with potential to yield new immune-based therapies.
