Drug name
Last update: Sep 2025CD388 (mAb)
Developer(s)
Drug information
Not provided
CD388
investigational
Biotherapeutic
Not provided
CD388 is an antiviral drug–Fc conjugate (DFC), created by attaching multiple copies of the neuraminidase inhibitor zanamivir to an antibody Fc fragment recognizing a highly conserved target on the influenza surface. Due to its long-acting properties, this product could be suited for a pre-exposure prophylaxis approach to prevent seasonal influenza. Company representative described CD388 at IDweek2024 as a ""potential effective and well-tolerated DFC for single-dose, season-long prevention of influenza
CD388 is an investigational candidate. A phase 3 trial was initiated in September 2025 (ANCHOR)
U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for CD388 for prevention of influenza A and B in adults and adolescents who are at higher risk of influenza complications due to underlying immunodeficiency, are at higher risk of severe influenza despite influenza vaccination, or those for whom vaccines are contraindicated.
Therapeutic area(s)
- Other(s) : "influenza virus"
- Pre-Exposure Prophylaxis (PrEP)
- Prevention
Administration route
Subcutaneous, Intramuscular
Associated long-acting platforms
Monoclonal antibodies and antibody drug conjugates
Use of drug
- Administered by a nurse
- Administered by a specialty health worker
- Every 6 months
To be determined - Stability demonstrated for 24 months at -20°C or 5°C
Dosage
investigational
unknown
investigated doses appear to be at 450mg (one single dose corresponds to 3 SQ injections of 150mg) for the phase 3 ANCHOR clinical trial
Stability demonstrated for 24 months at -20°C or 5°C
Not provided
Associated technologies
Not provided
Comment & Information
Developer(s)
Cidara Therapeutics
Cidara is developing targeted immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases. The Company’s proprietary Cloudbreak® platform enables development of novel drug-Fc conjugates (DFCs) that inhibit specific disease targets while simultaneously engaging the immune system.
Drug structure
Scale-up and manufacturing prospects
unknown
unknown
unknown
unknown
Excipients
Not provided
Not provided
Not provided
Delivery device(s)
Not provided
CD388 structure (linker + zanamivir dimer)
Compositions and methods for the treatment of viral infections include conjugates containing inhibitors of viral neuraminidase and MoT influenza or parainfluenza,
WO2021046549
Compound, combination
CIDARA THERAPEUTICS, INC.
Not provided
September 8, 2040
Granted: ZA, US, CO, AU, JP, NZ, CN Pending: HK, AE, BR, CA, CL, CR, EA, EC, EP (LMICs: AL, MK, TR, BA, ME, KH, MA, MD, TN, RS), ID, IL, KR, MX, MY, PE, PH, SA, SG, TH, TW, UA, VN, IN Withdrawn: AP
Zanamivir compound
Zanamivir compound (broad Markush, and specific structure as example 3) and method for treating influenza
WO1991016320
Compound
BIOTA SCIENTIFIC MANAGEMENT PTY LTD
Not provided
November 15, 2011
Expired
Publications
There are no publication
Additional documents
No documents were uploaded
Useful links
Collaborate for development
Consider on a case by case basis, collaborating on developing long acting products with potential significant public health impact, especially for low- and middle-income countries (LMICs), utilising the referred to long-acting technology
Share technical information for match-making assessment
Provide necessary technical information to a potential partner, under confidentiality agreement, to enable preliminary assessment of whether specific medicines of public health importance in LMICs might be compatible with the referred to long-acting technology to achieve a public health benefit
Work with MPP to expand access in LMICs
In the event that a product using the referred to long-acting technology is successfully developed, the technology IP holder(s) will work with the Medicines Patent Pool towards putting in place the most appropriate strategy for timely and affordable access in low and middle-income countries, including through licensing