French biotech Lovaltech announced that the Agence nationale de sécurité du médicament (ANSM) and the Comité de Protection des Personnes (CPP) have authorized the company's planned MUCOBOOST Phase 1 trial of LVT-001 nasal vaccine against COVID-19, and the trial is expected to start by the end of April 2025. The study, which is expected to enroll 36 adults aged 18-55, … [Read more...] about Lovaltech gets go-ahead for MUCOBOOST Phase 1 trial of LVT-001 intranasal vaccine against COVID-19
Regulatory
Health Canada approves Hikma’s Kloxxado naloxone nasal spray, which will be marketed in Canada by Emergent BioSolutions
According to Emergent BioSolutions, Health Canada has approved Hikma Pharmaceuticals' Kloxxado naloxone nasal spray 8 mg for the treatment of opioid overdose. In January 2025, Emergent announced that it was acquiring US and Canadian rights to Kloxxado, which has been approved in the US since 2021. Emergent, which already markets Narcan naloxone nasal spray 4 mg in … [Read more...] about Health Canada approves Hikma’s Kloxxado naloxone nasal spray, which will be marketed in Canada by Emergent BioSolutions
Xlear says US DOJ has requested dismissal of FTC case against company for unsupported claims about its OTC nasal spray
According to Xlear, the US Department of Justice has asked a US District Court judge to dismiss a suit filed by the US Federal Trade Commission in 2021 accusing the company of violating the COVID-19 Consumer Protection Act by claiming that its saline nasal spray with xylitol could prevent and treat COVID-19. The case (2:21-cv-00640-RJS) was brought in the US District … [Read more...] about Xlear says US DOJ has requested dismissal of FTC case against company for unsupported claims about its OTC nasal spray
Oragenics submits application for Phase 2 trial of ONP-002 intranasal neurosteroid powder for TBI
Oragenics announced that it has submitted an Investigator’s Brochure application to Australian authorities seeking the go-ahead for a Phase 2 trial of ONP-002, a dry powder intranasal neurosteroid, for the treatment of mild traumatic brain injury. In 2023, Oragenics acquired ONP-002 from Odyssey Health, which had announced Phase 1 results the previous year. In August … [Read more...] about Oragenics submits application for Phase 2 trial of ONP-002 intranasal neurosteroid powder for TBI
Tiziana submits IND for Phase 2 trial of intranasal foralumab in ALS
Tiziana Life Sciences announced that it has submitted an IND to the FDA seeking approval for a Phase 2 trial of intranasal foralumab in patients with amyotrophic lateral sclerosis. In November 2024, the company announced that it had received a grant from the ALS Association to fund a trial in patients with ALS. According to the company, the planned Phase 2 study would … [Read more...] about Tiziana submits IND for Phase 2 trial of intranasal foralumab in ALS
ASG says it held pre-IND meeting with FDA regarding Beta 1 PDE-5 inhibitor DPI for erectile dysfunction
Taipei-based inhaled drug developer Asia Scientific Global announced that it has completed a pre-IND meeting with the US FDA regarding its Beta 1 dry powder inhaler, a PDE-5 inhibitor that the company is developing for the treatment of erectile dysfunction. The company said that, "ASG will expedite the revision of clinical trial documents and execute additional test … [Read more...] about ASG says it held pre-IND meeting with FDA regarding Beta 1 PDE-5 inhibitor DPI for erectile dysfunction
Kexing Biopharm announces FDA approval of IND for GB05 human interferon α1b inhalation solution
According to Kexing Biopharm, the FDA has approved the company's IND for GB05 human interferon alpha-1b inhalation solution, which the company's subsidiary Shenzhen Kexing plans to advance into clinical development for the treatment of lung infections caused by respiratory syncytial virus in children. In April 2024, Kexing announced the initiation of a Phase 3 trial … [Read more...] about Kexing Biopharm announces FDA approval of IND for GB05 human interferon α1b inhalation solution
Cessatech gets positive notified body opinion regarding CT001 sufentanil / ketamine analgesic nasal spray device
According to Cessatech, a positive notified body opinion has been issued under Article 117 of the Medical Devices Regulation for the company's CT001 sufentanil / ketamine nasal spray. Cessatech says that it expects to submit a marketing application to the EMA later this year seeking approval of CT001 for the treatment of acute pain in children. In May 2024, the … [Read more...] about Cessatech gets positive notified body opinion regarding CT001 sufentanil / ketamine analgesic nasal spray device
FDA clears Kinaset’s IND for a Phase 2b trial of KN-002 frevecitinib DPI in patients with asthma
According to Kinaset Therapeutics, the FDA has cleared the company's IND for a Phase 2b trial of its KN-002 frevecitinib dry powder inhaler. The 12-week Phase 2 trial, which will evaluate 3 doses of dry powder frevecitinib in patients with severe asthma that is not adequately controlled by ICS / LABA therapy, is expected to get underway in mid-2025. Kinaset acquired … [Read more...] about FDA clears Kinaset’s IND for a Phase 2b trial of KN-002 frevecitinib DPI in patients with asthma
FDA clears IND for a Phase 1 trial of Ocugen’s OCU500 COVID-19 vaccine via inhalation and nasal administration
Ocugen, Inc. announced that the FDA has cleared an IND for a Phase 1 trial of OCU500 vaccine for the prevention of COVID-19, which the company licensed from Washington University in St. Louis in 2022. The trial, which will evaluate inhaled and intranasal administration of the vaccine, will be conducted by the NIH's National Institute of Allergy and Infectious … [Read more...] about FDA clears IND for a Phase 1 trial of Ocugen’s OCU500 COVID-19 vaccine via inhalation and nasal administration