MK-1406 / Merck (MSD) - LARVOL DELTA

A Trial to Evaluate the Effect of CD388/MK1406 on the Immunogenicity of Fluzone HD Vaccine (CD388.SQ.1.08/MK-1406-007) (clinicaltrials.gov) - P1 | N=710 | Active, not recruiting | Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | N=100 ➔ 710

Enrollment change

A Clinical Trial of MK-1406 in Healthy Participants (MK-1406-008) (clinicaltrials.gov) - P1 | N=400 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

ANCHOR: A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza (clinicaltrials.gov) - P3 | N=10000 | Active, not recruiting | Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Recruiting ➔ Active, not recruiting | N=7500 ➔ 10000 | Trial completion date: Jan 2027 ➔ Jun 2027 | Trial primary completion date: Jan 2027 ➔ Jun 2027

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Multiple Myeloma • Respiratory Diseases • CD4

ANCHOR: A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza (clinicaltrials.gov) - P3 | N=7500 | Recruiting | Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Active, not recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Multiple Myeloma • Respiratory Diseases • CD4

Metabolism and excretion pathways of CD388, a novel drug-fragment crystallizable conjugate for prevention of seasonal or pandemic influenza. (PubMed, Drug Metab Dispos) - "Intact CD388 is not cleared renally, improving half-life and the potential for single CD388 administration to provide seasonal influenza protection. Additionally, the minimal metabolism of CD388 make the potential for metabolic drug interactions low."

Journal • Infectious Disease • Influenza • Respiratory Diseases

A Trial to Evaluate the Effect of CD388 on the Immunogenicity of Fluzone® HD Vaccine (clinicaltrials.gov) - P1 | N=100 | Active, not recruiting | Sponsor: Cidara Therapeutics Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: May 2026 ➔ Dec 2026 | Trial primary completion date: May 2026 ➔ Dec 2026

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

Merck to Complete Acquisition of Cidara Therapeutics (Merck (MSD) Press Release) - "Merck completed the cash offer at a purchase price of $221.50 per share of common stock of Cidara, without interest and subject to deduction for any required tax withholding. As of the tender offer expiration at one minute after 11:59 p.m., Eastern Time, on January 6, 2026, 27,149,333 shares of common stock were validly tendered and not withdrawn, representing approximately 85.96% of the total number of Cidara’s issued and outstanding shares of common stock."

M&A • Influenza

NAVIGATE-2: A Study to Evaluate the Safety, Pharmacokinetics, and Occurrence of Anti-Drug Antibodies Following Annual Doses of CD388 (clinicaltrials.gov) - P2 | N=400 | Active, not recruiting | Sponsor: Cidara Therapeutics Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed

A Trial to Evaluate the Effect of CD388 on the Immunogenicity of Fluzone® HD Vaccine (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Cidara Therapeutics Inc.

New P1 trial • Infectious Disease • Influenza • Respiratory Diseases

ANCHOR: A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza (clinicaltrials.gov) - P3 | N=6000 | Active, not recruiting | Sponsor: Cidara Therapeutics Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

Merck to buy Cidara Therapeutics for $9.2 billion as Keytruda patent cliff approaches (iNVEZZ) - "Merck & Co. has agreed to acquire biotechnology firm Cidara Therapeutics in a $9.2 billion deal, accelerating efforts to broaden its respiratory portfolio as it prepares for the loss of exclusivity on its blockbuster cancer drug Keytruda later this decade...At the centre of the acquisition is Cidara’s lead programme, CD388, a long-acting antiviral agent now in Phase 3 trials. The treatment is being tested as a preventive therapy for influenza in people at high risk of severe illness."

M&A • Infectious Disease

NAVIGATE-2: A Study to Evaluate the Safety, Pharmacokinetics, and Occurrence of Anti-Drug Antibodies Following Annual Doses of CD388 (clinicaltrials.gov) - P2 | N=400 | Recruiting | Sponsor: Cidara Therapeutics Inc.

New P2 trial

ANCHOR: A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza (clinicaltrials.gov) - P3 | N=6000 | Recruiting | Sponsor: Cidara Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

NAVIGATE: Study of CD388 for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications (clinicaltrials.gov) - P2 | N=5071 | Completed | Sponsor: Cidara Therapeutics Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Cidara Therapeutics Receives U.S. FDA Breakthrough Therapy Designation for CD388 in Seasonal Influenza Prevention (GlobeNewswire) - "The Breakthrough Therapy designation is based on positive results from the Phase 2b NAVIGATE trial in which CD388 provided statistically significant prevention of seasonal influenza in healthy unvaccinated adults aged 18-64."

Breakthrough therapy • Influenza

Prophylactic Efficacy of CD388, a Novel Drug-Fc Conjugate, in a Human Influenza A/H3N2 Virus Challenge Model: A Randomized, Controlled Phase 2a Study. (PubMed, Clin Infect Dis) - P2 | "CD388 was well-tolerated and demonstrated prophylactic activity against RT-qPCR-confirmed influenza infection in a human challenge study. The efficacy of CD388 in preventing influenza will be confirmed in larger studies. Clinical Trials Registration.  ClinicalTrials.gov identifier: NCT05523089."

Clinical • Journal • P2a data • Infectious Disease • Influenza • Respiratory Diseases

ANCHOR: A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza (clinicaltrials.gov) - P3 | N=5500 | Not yet recruiting | Sponsor: Cidara Therapeutics Inc.

New P3 trial • Infectious Disease • Influenza • Respiratory Diseases

Absorption, distribution, metabolism, and excretion of an antiviral drug-Fc conjugate CD388 following subcutaneous administration of 14C-CD388 in the rat. (PubMed, Drug Metab Dispos) - "Catabolism of the Fc domain resulted in formation of metabolites containing the unmodified dimeric zanamivir plus linker. These data support the mode of action of CD388 and demonstrate that the conjugation of zanamivir to the Fc domain is stable, thereby enabling CD388 to maintain its potent antiviral activity."

Journal • Preclinical • Infectious Disease • Influenza • Respiratory Diseases

Drug-Fc conjugate CD388 targets influenza virus neuraminidase and is broadly protective in mice. (PubMed, Nat Microbiol) - "CD388 improves the antiviral activity of zanamivir, demonstrating potent, universal activity across influenza A and B viruses, including high pathogenicity and neuraminidase inhibitor resistant strains, a low potential for resistance development and potent efficacy in lethal mouse infection models. These results suggest that CD388 has the potential for universal prevention of influenza A and B in healthy and high-risk populations."

Journal • Preclinical • Infectious Disease • Influenza • Respiratory Diseases

Cidara Therapeutics Announces Two Presentations on CD388 in Influenza at International Conference on Antiviral Research (ICAR) 2025 (GlobeNewswire) - "Cidara Therapeutics, Inc...today announced two upcoming presentations at the 38th International Conference on Antiviral Research (ICAR). The conference takes place from March 17-21, 2025 in Las Vegas, Nevada. Cidara’s presentations will highlight the study design, demographic information, and preliminary safety data from the ongoing Phase 2b NAVIGATE trial of CD388, as well as dose optimization models for evaluation of CD388 in a Phase 3 study."

Clinical • Clinical protocol • P2b data • Influenza

Cidara Therapeutics Announces Publication of CD388 Preclinical Data in Nature Microbiology (GlobeNewswire) - "The publication describes CD388 and its potential for universal activity across influenza A and B viruses in cellular and animal models. Administration of CD388 resulted in the following: Potent, universal activity against all influenza A and B virus strains, including high pathogenicity strains like H5N1, also known as avian influenza or bird flu, and strains that are resistant to approved neuraminidase inhibitors; Low potential for resistance development; Efficacy at similar exposures in immune-competent and immune-compromised lethal challenge models in mice demonstrating that efficacy is driven predominantly by the intrinsic antiviral activity of CD388."

Preclinical • Infectious Disease • Influenza

NAVIGATE: Study of CD388 for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications (clinicaltrials.gov) - P2 | N=5000 | Active, not recruiting | Sponsor: Cidara Therapeutics Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

NAVIGATE: Study of CD388 for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications (clinicaltrials.gov) - P2 | N=5000 | Recruiting | Sponsor: Cidara Therapeutics Inc. | Trial completion date: May 2025 ➔ Sep 2025 | Trial primary completion date: May 2025 ➔ Sep 2025

Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

Single-Dose and Repeat Single-Dose Ascending Dose Study Evaluating Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intramuscular CD388, a Novel Long-acting Drug-Fc Conjugate for Universal Prevention of Seasonal and Pandemic Influenza (IDWeek 2024) - No abstract available

Clinical • PK/PD data • Infectious Disease • Influenza

CD388, a Novel Drug-Fc Conjugate (DFC), Demonstrates Prophylactic Activity in an Influenza Human Challenge Model (IDWeek 2024) - No abstract available

Infectious Disease • Influenza