Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MK-1654
Clesrovimab · 4 trials · 5 indications
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included erythema, pain, and swelling. The number of participants with solicited injection-site AEs in RSV Season 1 is reported.
Fever was defined as maximum rectal temperature ≥102.2 °F (39.0 °C) or maximum axillary temperature ≥101.7 °F. The number of participants with solicited daily body temperature of fever in RSV Season 1 is reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included decreased appetite, irritability, and somnolence. The number of participants with solicited systemic AEs in RSV Season 1 is reported.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1 is reported.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Rash AESI included urticaria and drug eruption. The number of participants with rash AESI in RSV Season 1 is reported.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with nonserious AEs in RSV Season 1 is reported.
An SAE is any untoward medical occurrence in a clinical study participant that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. The number of participants with SAEs in RSV Season 1 is reported.
Outpatient and inpatient MALRI was defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration due to respiratory symptoms; AND 3) RSV-positive reverse transcriptase polymerase chain reaction (RT-PCR) nasopharyngeal sample. Per protocol, the participants with outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1 participants.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included redness/erythema, swelling, and pain/tenderness. Per protocol, the percentage of RSV season 1 participants with solicited injection-site AEs were reported.
Fever was defined as rectal temperature ≥102.2°F (≥39.0°C) or axillary temperature ≥101.7°F (≥38.7°C). Per protocol, the percentage of RSV season 1 participants with fever were reported.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included irritability, somnolence/drowsiness, and appetite lost. Per protocol, the percentage of RSV season 1 participants with solicited systemic AEs were reported.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Anaphylaxis/Hypersensitivity AESI included anaphylaxis, angioedema, bronchospasm, drug hypersensitivity, dyspnea, hypersensitivity, dysphonia, and wheezing. Per protocol, the percentage of RSV season 1 participants with anaphylaxis/hypersensitivity AESI were reported.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Rash AESI included acute generalized exanthematous pustulosis, drug eruption, drug reaction with eosinophilia and systemic symptoms, erythema multiforme, generalized rash of exfoliative nature, Stevens-Johnson syndrome, toxic epidermal necrolysis, and urticaria. Per protocol, the percentage of RSV season 1 participants with rash AESI were reported.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, the percentage of RSV season 1 participants with ≥1 nonserious AE were reported.
An SAE was any untoward medical occurrence that results in death; is life-threatening; required inpatient hospitalization/prolongs existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical event. Per protocol, the percentage of participants in RSV season 1 and RSV season 2 with SAEs were reported.
The VL-AUC will be determined by reverse transcription qualitative integrated cycler polymerase chain reaction (RT-qPCR) after viral inoculation.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection site AEs were monitored from Day 1 to Day 5.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs were monitored from Day 1 to Day 5.
An SAE is any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant injury/incapacity; is a congenital anomaly/birth defect; or is an other important medical event.
| Arm | Type | Description |
|---|---|---|
| Clesrovimab | EXPERIMENTAL | Participants will receive intramuscular (IM) injections of clesrovimab and placebo |
| Palivizumab | ACTIVE_COMPARATOR | Participants will receive IM injections. |
| Clesrovimab 105 mg | EXPERIMENTAL | Participants receive a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1. An eligible subset of participants from RSV Season 1 will enter RSV season 2. |
| Placebo | PLACEBO_COMPARATOR | Participants receive a single IM administration of placebo on Day 1. An eligible subset of participants from RSV Season 1 will enter RSV season 2. |
| Clesrovimab 100 mg | EXPERIMENTAL | Participants receive a single IV infusion of clesrovimab 100 mg on Day 1. |
| Clesrovimab 200 mg | EXPERIMENTAL | Participants receive a single IV infusion of clesrovimab 200 mg on Day 1. |
| Clesrovimab 300 mg | EXPERIMENTAL | Participants receive a single IV infusion of clesrovimab 300 mg on Day 1. |
| Clesrovimab 900 mg | EXPERIMENTAL | Participants receive a single IV infusion of clesrovimab 900 mg on Day 1. |
| Panel A: Pre-term clesrovimab Dose 1 | EXPERIMENTAL | Pre-term infants will receive clesrovimab Dose 1 via intramuscular (IM) injection and will be followed for up to 365 days. |
| Panel B: Pre-term clesrovimab Dose 2 | EXPERIMENTAL | Pre-term infants will receive clesrovimab Dose 2 via IM injection and will be followed for up to 365 days. |
| Panel C: Pre-term clesrovimab Dose 3 | EXPERIMENTAL | Pre-term infants will receive clesrovimab Dose 3 via IM injection and will be followed for up to 365 days. |
| Panel D1: Pre-term clesrovimab Dose 4 | EXPERIMENTAL | Pre-term infants enrolled prior to AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 365 days. |
| Panel D2: Pre-term clesrovimab Dose 4 | EXPERIMENTAL | Pre-term infants enrolled after AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 545 days. |
| Panel E1: Full-term clesrovimab Dose 4 | EXPERIMENTAL | Full-term infants enrolled prior to AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 365 days. |
| Panel E2: Full-term clesrovimab Dose 4 | EXPERIMENTAL | Full-term infants enrolled after AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 545 days. |
| Name | Type | Description |
|---|---|---|
| Clesrovimab | BIOLOGICAL | IM injection |
| Palivizumab | BIOLOGICAL | IM injection |
| Placebo | BIOLOGICAL | IM injection |
| RSV-A Memphis 37b | BIOLOGICAL | Approximately 4Log10 plaque-forming units (PFU)/mL RSV-A virus inoculation strain Memphis 37b administered via intranasal inoculation. |
Inclusion Criteria: * Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations and meet defined criteria for the Early or Moderate Pre-term Group or the chronic lung disease (CL...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
Clesrovimab is an investigational monoclonal antibody being developed for the prevention of respiratory syncytial virus (RSV) infection and respiratory tract infection in infants and children. It is designed to protect against RSV disease, including in infants at increased risk for severe RSV disease.
Clesrovimab is being developed by Merck & Company, Inc., which trades under the ticker MRK. The drug is also known by the development code MK-1654, and Merck's clinical program includes studies in infants, children, and healthy adult volunteers.
Clesrovimab is in Phase 3 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA. Its clinical program includes completed Phase 1, Phase 2, and Phase 3 trials evaluating safety, tolerability, pharmacokinetics, and efficacy in RSV prevention.
Clesrovimab has been studied in completed trials including NCT04938830, a Phase 3 study in infants and children at increased risk for severe RSV disease, NCT04767373, a Phase 2 efficacy and safety study in infants, NCT04086472, a Phase 2a human challenge study, and NCT03524118, a Phase 1 study in infants.
Yes, clesrovimab is the same drug as MK-1654. MK-1654 is Merck's internal development code for clesrovimab, and the two names refer to the same investigational monoclonal antibody. Clinical trial titles for the program list the drug as clesrovimab (MK-1654).
Clesrovimab is a monoclonal antibody, an antibody-based therapeutic. It is being developed for RSV infection and related respiratory tract infection, with clinical trials enrolling infants, children, and healthy adult volunteers, including a Phase 2a human challenge study conducted in the United Kingdom.