AN INTERVENTIONAL, PHASE 1b, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, MULTI-CENTER, DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SISUNATOVIR IN PEDIATRIC PARTICIPANTS UP TO AGE 60 MONTHS WITH RESPIRATORY SYNCYTIAL VIRUS (RSV) LOWER RESPIRATORY TRACT INFECTION (LRTI)

The purpose of the study is to learn about the safety and amount of sisunatovir in the blood of infants and children up to age 60 months. These children have Lower Respiratory Tract Infection (LRTI) caused by Respiratory Syncytial Virus (RSV). LRTI is the infection to the lower airways such as lungs.
This study will help inform the amount of sisunatovir to be used in future studies of sisunatovir in children.
This study is seeking for participants who:
* Are 1 day to less than or equal to 60 months of age
* weigh more than or equal to 2.5 kilograms to less than or equal to 23 kilograms.
* Have been tested to have RSV by medical tests.
* show signs of LRTI.
All participants in the study will receive many amounts of sisunatovir or placebo. Placebo is a pill that does not have any medicine in it.
Up to 7 visits are required for the study. Some of these visits include checking participants health over the phone and/or a visit at home.
The study will compare the experiences of infants and children receiving sisunatovir to identify the amount of sisunatovir to be used in future studies in infants and children.

Start Date15 Feb 2024

Sponsor / Collaborator

Pfizer Inc.

NCT06079320

/ TerminatedPhase 2/3

AN INTERVENTIONAL PHASE 2/3, ADAPTIVE, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ORAL SISUNATOVIR COMPARED WITH PLACEBO IN NON-HOSPITALIZED SYMPTOMATIC ADULTS WITH RESPIRATORY SYNCYTIAL VIRUS INFECTION WHO ARE AT RISK OF PROGRESSION TO SEVERE ILLNESS

The purpose of this study is to learn about the safety and effects of sisunatovir. Sisunatovir is studied for the possible treatment of Respiratory Syncytial Virus (RSV). RSV is a virus that causes lung infections with cold-like symptoms, but it can cause severe illness in some people. Sisunatovir is studied in adults:
* who are not admitted to the hospital and
* who have high chances of having a severe illness from RSV infection.
This study is seeking participants who:
* Are confirmed to have RSV.
* Have symptoms of a lung infection.
* Are 18 years of age or older.
* Have one or more of the following which increases the chances of RSV illness:
* A long-term lung disease.
* heart failure.
* a condition that weakens the immune system.
* Are 65 years of age or older and do not have any of the conditions above
Half of the participants in this study will receive sisunatovir. The other half will receive a placebo for 5 days. Placebo looks same like the study medicine but does not have any medication. Both sisunatovir and placebo will be taken by mouth. The study will compare the experiences of people receiving sisunatovir to those of the people who do not. This will help decide if sisunatovir is safe and effective.
Participants will attend about 8-10 study visits over 5 weeks. During this time, they will have:
* visits at the study clinic,
* blood work,
* swabs of the nose,
* questionnaires,
* a follow-up phone call.

Start Date08 Dec 2023

Sponsor / Collaborator

Pfizer Inc.

NCT05987072

/ CompletedPhase 1

A PHASE 1, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY FOLLOWING SINGLE AND MULTIPLE DOSES OF SISUNATOVIR IN CHINESE HEALTHY PARTICIPANTS

The purpose of the study is to learn about:
* The activity of sisunotavir in the body over a period. It includes the processes by which sisunotavir is absorbed, distributed in the body, localized in the tissues, and removed from the body.
* safety and tolerability of sisunatovir (PF-07923568) in Chinese healthy adult participants.
This information is being collected to support further clinical development as well as medicine registration in China.
This study is seeking for participants who:
* are male and female participants aged 18 to 65 years of age.
* are male and female participants who are healthy as seen by medical tests.
* have body mass index (BMI) of 19 to 27 kg/m2 and a total body weight of more than 50 kilograms (110 pounds).
About 12 participants will receive sisunatovir. Four capsules (strength=50 milligrams, 200 milligrams in total) of Sisunatovir will be given on Day 1 on empty stomach. This will be followed by 8 capsules of sisunatovir with 12 hours gap in between four capsules from Days 4 to 7. The participants will have to take 4 capsules of sisunatovir in the morning of 8th day with a meal.
The total time of participants will be in the study is about 71 days. This includes the screening visit to the Follow-up contact. In screening visit, participants will be tested to see if they are fit to take part in the study.

Start Date03 Nov 2023

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with Sisunatovir

100 Translational Medicine associated with Sisunatovir

100 Patents (Medical) associated with Sisunatovir

Literatures (Medical) associated with Sisunatovir

01 Sep 2024·REVIEWS IN MEDICAL VIROLOGY

Systematic Review of the Efficacy and Safety of RSV‐Specific Monoclonal Antibodies and Antivirals in Development

Review

Author: Adam W. Bartlett ; Siobhan Hurley ; William Rawlinson ; Andrea T. K. Sevendal ; Gregory J. Walker

ABSTRACT:

Respiratory syncytial virus (RSV) is a leading cause of acute respiratory infection amongst all ages, causing a significant global health burden. Preventative and therapeutic options for RSV infection have long been under development, and recently, several widely‐publicised vaccines targeting older adult and maternal populations have become available. Promising monoclonal antibody (mAb) and antiviral (AV) therapies are also progressing in clinical trials, with the prophylactic mAb nirsevimab recently approved for clinical use in infant populations. A systematic review on current progress in this area is lacking. We performed a systematic literature search (PubMed, Embase, Web of Science, ClinicalTrials.gov, EudraCT, ANZCTR—searched Nov 29th, 2023) to identify studies on all RSV‐specific mAbs and AV therapies that has undergone human clinical trials since year 2000. Data extraction focused on outcomes related to the therapeutic efficacy and safety of the intervention on trial, and all studies were graded against the OCEBM Levels of Evidence Table. Results from 59 studies were extracted, covering efficacy and safety data on six mAbs (motavizumab, motavizumab‐YTE, nirsevimab, ALX‐0171, suptavumab, clesrovimab) and 12 AV therapies (ALN‐RSV01, RSV604, presatovir, MDT‐637, lumicitabine, IFN‐α1b, rilematovir, enzaplatovir, AK0529, sisunatovir, PC786, EDP‐938). Of the mAbs reviewed, nirsevimab and clesrovimab hold considerable promise. The timeline for RSV‐specific AV availability is less advanced, although EDP‐938 and AK0529 have reported promising phase 2 efficacy and safety data. Moving forward, passive immunisation and treatment options for RSV infection will play a significant role in reducing the health burden of RSV, complementing recent advancements in vaccine development.

Trial Registration:

PROSPERO registration: CRD42022376633

27 Jan 2020·Antimicrobial agents and chemotherapyQ2 · MEDICINE

A Randomized, Placebo-Controlled, Respiratory Syncytial Virus Human Challenge Study of the Antiviral Efficacy, Safety, and Pharmacokinetics of RV521, an Inhibitor of the RSV-F Protein

Q2 · MEDICINE

Article

Author: Littler, Edward ; Wilson, Lynn ; Thomas, Elaine ; Efthimiou, John ; Mori, Julie ; Tait, Dereck ; Mathews, Neil ; Powell, Kenneth ; Kim, Young-In ; DeVincenzo, John ; Harland, Rachel ; Cockerill, Stuart

Effective treatments for respiratory syncytial virus (RSV) infection are lacking. Here, we report a human proof-of-concept study for RV521, a small-molecule antiviral inhibitor of the RSV-F protein. In this randomized, double-blind, placebo-controlled trial, healthy adults were challenged with RSV-A Memphis-37b.

PEDIATRIC INFECTIOUS DISEASE JOURNAL

Safety and Pharmacokinetics of the RSV Fusion Inhibitor Sisunatovir Across Two Early-phase Studies in Infants and Children With RSV Lower Respiratory Tract Infection

Article

Author: Rojo, Pablo ; Franke, Ryan M. ; Amo, Kiyoko ; Alami, Negar Niki ; Toh, Teck-Hock ; Kudela, Maria ; Ogunade, Ilori ; Jordan, Iolanda ; Shoji, Satoshi ; Thomas, Elaine ; Calvo, Cristina ; Haumann, Brett ; Nemeth, Agnes ; Toussi, Sima S. ; Banerjee, Anindita ; Daud, Mariana ; Newland, Jason ; Zhang, Shu ; Welch, Heather ; Rees, Sally ; Srisingh, Klaita ; Oku, Shozo ; Towner, William

Background::

Sisunatovir is an investigational respiratory syncytial virus (RSV) antiviral that was effective in an adult human viral challenge study.

Methods::

In 2 multicenter studies, safety and pharmacokinetics of sisunatovir were evaluated in hospitalized individuals 1 month to 36 months of age (Study 1) and outpatient and hospitalized individuals 1 day to 60 months of age (Study 2) with RSV lower respiratory tract infection (RSV-LRTI). In Study 1 Part A, participants received single sisunatovir doses; in Part B, participants received placebo or multiple ascending sisunatovir doses every 12 hours for 5 days. In Study 2, participants received weight-based sisunatovir dosing or placebo every 12 hours for 5 days.

Results::

In Study 1 Part A, 19 participants received sisunatovir; 31 in Part B received sisunatovir (n = 22) or placebo (n = 9). Adverse events (AEs) were reported by 11 (57.9%) and 12 (38.7%) participants in Parts A and B, respectively. In Study 2, 10 participants received sisunatovir (n = 6) or placebo (n = 4). No treatment-related serious AEs were reported; all AEs were mild or moderate. In Study 1 Part A 12 hours post-dose, mean sisunatovir concentrations were within safety margins. In Part B, at the highest dose assessed for each group, steady-state trough concentrations surpassed those effective in the adult challenge study.

Conclusions::

In children with RSV-LRTI, sisunatovir was safe and well tolerated. The pediatric multiple-dose regimen achieved plasma concentrations effective at reducing viral load and symptoms in an adult challenge study; however, further studies are needed to identify doses providing comparable exposure across pediatric populations.

ClinicalTrials.gov registration number::

NCT04225897 (registered December 11, 2019); NCT06102174 (registered October 6, 2023)

News (Medical) associated with Sisunatovir

20 Apr 2026

·allsci.com

EC approves Merck’s Enflonsia for RSV prevention in infants

The European Commission has approved Enflonsia (clesrovimab) for the prevention of RSV lower respiratory tract disease in neonates and infants during their first RSV season. Merck noted that the product is the first RSV preventive option in the European Union not requiring weight-based dosing. The authorization covers all 27 EU member states as well as Iceland, Liechtenstein, and Norway, and adds to prior approvals in the US, Canada, and Switzerland. The EC authorization permits a fixed 105 mg intramuscular dose regardless of infant weight, designed to provide protection across five months — the duration of a typical RSV season. For infants born during the RSV season, the label specifies administration within the first week of life; for those born outside the season, dosing should occur shortly before it begins. Infants undergoing cardiac surgery with cardiopulmonary bypass are recommended an additional 105 mg dose once stable post-surgery. The product carries a contraindication for infants with hypersensitivity to clesrovimab or its excipients, and Merck said the timing of country-level availability will depend on completion of reimbursement procedures. The approval is supported by data from two trials. The pivotal Phase IIb/III CLEVER trial (NCT04767373) enrolled 3,614 preterm and full-term infants randomized 2:1 to a single 105 mg dose of clesrovimab or saline placebo. The primary endpoint — incidence of RSV-associated medically attended lower respiratory infection through 150 days — was reduced by 60.4% versus placebo (95% CI: 44.1, 71.9; p<0.001). RSV-associated hospitalization through five months, the key secondary endpoint, was reduced by 84.2% (95% CI: 66.6, 92.6; p<0.001). Exploratory analyses showed a 91.7% reduction in severe medically attended lower respiratory infection and a 90.9% reduction in RSV-associated lower respiratory tract hospitalization over the same period. The safety profile was comparable to placebo, with the most frequent adverse reactions being injection-site pain (6.5%), injection-site erythema (4.4%), injection-site swelling (3.2%), and rash (2.3%), the majority mild or moderate. Supporting data came from an interim analysis of the Phase III SMART trial (NCT04938830), which compared clesrovimab against monthly palivizumab in 896 infants at increased risk for severe RSV disease. Incidence rates of medically attended lower respiratory infection and hospitalization were comparable between the two arms, with efficacy in the high-risk population established by pharmacokinetic extrapolation from the CLEVER trial. Results from both studies were published in the New England Journal of Medicine in September 2025. The RSV market context RSV is among the leading causes of infant hospitalization globally, capable of progressing to bronchiolitis and pneumonia in both healthy and high-risk infants. Until recently, prophylaxis options were limited largely to palivizumab (Synagis; AstraZeneca), a monthly weight-based injection restricted in most health systems to high-risk populations due to cost and dosing burden. The 2023 approval of nirsevimab (Beyfortus; AstraZeneca/Sanofi) broadened access to a single-season, single-dose option for all infants, and clesrovimab now joins that class with a fixed-dose presentation that Merck said eliminates the need for weight-based calculation at the point of care. The clesrovimab EC approval adds to a growing field of long-acting monoclonal antibodies for infant RSV prophylaxis, with the fixed-dose feature representing a practical distinction from palivizumab and a potential implementation consideration for healthcare systems evaluating uptake. The CLEVER and SMART data also indicate that the antibody maintains activity in high-risk subgroups — including preterm infants and those with chronic lung disease or congenital heart disease — populations where the historical standard of care had been palivizumab administered monthly across the season. The broader RSV prevention and treatment landscape continues to evolve. Pfizer’s maternal RSV vaccine Abrysvo received FDA approval for maternal immunization in 2023, offering an alternative route to infant protection via transplacental antibody transfer, and Moderna’s mRNA-1345 maternal immunization program remains in Phase III investigation. Both approaches, if widely adopted, could affect demand for prophylactic monoclonal antibodies across the infant population. On the treatment side, no antiviral is approved for RSV in infants; investigational agents including ziresovir (Ark Biosciences) and sisunatovir (Pfizer) are in Phase II/III and Phase II evaluation respectively for RSV lower respiratory tract infection treatment in hospitalized infants, a niche that prophylactic antibodies do not address. Merck itself is pursuing MK-5348, an RSV polymerase inhibitor, in Phase I/II for treatment indications, positioning the company across both the preventive and potential therapeutic segments of the RSV space. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

08 Oct 2024

·endpts.com

Pfizer culls RSV treatment from ReViral acquisition

Pfizer has terminated development of its RSV treatment candidate sisunatovir, a viral inhibitor picked up in its up to $525 million acquisition of ReViral in 2022. The New York drug company — which is facing an activist investor that’s expected to call for major changes at the company — ended a Phase 2/3 trial and a Phase 1 study of the oral inhibitor, according to updates to a federal clinical trials database. “There have been ongoing challenges in the sisunatovir clinical development program, including a drug-drug interaction with antacids,” a Pfizer spokesperson said in an emailed statement to Endpoints News . “While Pfizer has been working diligently to resolve the challenges, we decided to stop the development of sisunatovir.” The company will now focus on “identifying and advancing the development of other investigational therapeutics that have the greatest potential to prevent and treat RSV disease and other viral respiratory pathogens,” the spokesperson said. The cull wasn’t because of safety issues, Pfizer said. The drug, which has FDA fast track designation for both pediatric and adult indications, was still listed on Pfizer’s latest quarterly update in July and still appears on its pipeline page. With the ReViral deal, Pfizer was hoping to be able to both prevent RSV with its vaccine, and treat it with sisunatovir — much as it did for Covid-19 with a vaccine and antiviral pill. And when the companies announced the deal in 2022, then-ReViral CEO Alex Sapir called Pfizer “an optimal partner given their commitment to RSV.” At the time, Pfizer said it expected ReViral’s programs to bring in annual revenue of $1.5 billion or more. Pfizer is one of three pharma companies to market a vaccine for respiratory syncytial virus. The company makes Abrysvo , which was approved in 2023, while Moderna sells mResvia and GSK markets Arexvy. This season’s vaccine uptake has been slower than projected , Wall Street analysts have said. ReViral was one of many targets on which Pfizer has spent its Covid-19 cash. It acquired cancer drug developer Seagen for $43 billion, $11.6 billion to get migraine drugs from Biohaven, and $6.7 billion for Arena Pharmaceuticals and its immuno-inflammatory programs. It also spent $5.4 billion for sickle cell biotech Global Blood Therapeutics — only to pull the main product behind the deal for safety reasons.

VaccineAcquisitionFast TrackIPO

01 Aug 2023

·www.fiercebiotech.com

Pfizer takes scalpel to early-phase pipeline, slicing off RSV, eczema, sickle cell and cancer programs

Pfizer thinned its sickle cell pipeline 10 months after its buyout of Global Blood Therapeutics. Pfizer is ringing the changes as it exits the second quarter, tossing out a midstage pneumococcal vaccine candidate and a handful of phase 1 assets including a respiratory syncytial virus (RSV) prospect it picked up in last year’s ReViral takeover. The quarterly pipeline update (PDF) features the removal of two phase 2 assets, including the previously disclosed defenestration of its oral obesity and diabetes candidate lotiglipron over safety concerns. The other phase 2 candidate to get the ax in the update is PF-06842433, a vaccine that was in development for the prevention of invasive and noninvasive pneumococcal infections in infants and children. Pfizer ran (PDF) a phase 1/2 clinical trial of the seven-valent pneumococcal conjugate vaccine from 2018 to 2020. The vaccine candidate was designed to complement the pneumococcal coverage provided by Prevnar 13, but, with Prevnar 20 now approved, Pfizer has moved on from the program. The update also covers the discontinuation of six phase 1 assets, including PF-07923567. The N-protein inhibitor, also known as RV-299, is one of the RSV candidates that Pfizer added to its pipeline in a deal to buy ReViral for $436 million upfront last year. Work on the most advanced program included in the deal, sisunatovir, continues, but Pfizer has decided it can do without PF-07923567. Pfizer is also jettisoning a pair of atopic dermatitis programs and another pair of solid tumor assets. In atopic dermatitis, the Big Pharma followed up the discontinuation of one topical “soft” JAK inhibitor last year by axing a similar molecule that it was studying in the same phase 1 trial. Alongside that, it has cut PF-07242813, a CD1a inhibitor, after wrapping up a phase 1 trial in healthy volunteers and atopic dermatitis patients. The solid tumor discontinuations fall on the AXL/MERTK inhibitor PF-07265807 and the IL15 activator PF-07209960. Pfizer acquired the AXL/MERTK inhibitor in the Array BioPharma buyout, but evidence the mechanism lowers the immune activation threshold and boosts anti-tumor immunity has failed to yield a clinical candidate the drugmaker thinks warrants further development. Finally, Pfizer has thinned its sickle cell pipeline 10 months after its buyout of Global Blood Therapeutics positioned it as a force in the indication. The discontinuation affects PF-07209326, an anti-E-selectin inhibitor that was in development at Pfizer prior to the Global Blood takeover. The confirmation follows the news last week that Pfizer is walking away from a sickle cell disease licensing deal with Syros Pharmaceuticals that it inherited from its takeover of Global Blood.

Phase 1VaccineAcquisitionPhase 2License out/in

100 Deals associated with Sisunatovir

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Respiratory Syncytial Virus Infections	Phase 3	China	Pfizer Inc.	08 Dec 2023
Respiratory Syncytial Virus Infections	Phase 3	Japan	Pfizer Inc.	08 Dec 2023
Respiratory Syncytial Virus Infections	Phase 3	Argentina	Pfizer Inc.	08 Dec 2023
Respiratory Syncytial Virus Infections	Phase 3	Australia	Pfizer Inc.	08 Dec 2023
Respiratory Syncytial Virus Infections	Phase 3	Brazil	Pfizer Inc.	08 Dec 2023
Respiratory Syncytial Virus Infections	Phase 3	Canada	Pfizer Inc.	08 Dec 2023
Respiratory Syncytial Virus Infections	Phase 3	Czechia	Pfizer Inc.	08 Dec 2023
Respiratory Syncytial Virus Infections	Phase 3	Germany	Pfizer Inc.	08 Dec 2023
Respiratory Syncytial Virus Infections	Phase 3	India	Pfizer Inc.	08 Dec 2023
Respiratory Syncytial Virus Infections	Phase 3	Italy	Pfizer Inc.	08 Dec 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04225897 \| NCT06102174 (Pubmed \| Pediatr Infect Dis J)	Early Phase 1	Lower Respiratory Tract Infections	81	Sisunatovir	sairbrognw(hakruijmuh) = ehpgndqiub zzwsuxcpzd (yulgmitzly )	Positive	12 Feb 2026
				Sisunatovir (Study 1 Part B)	sairbrognw(hakruijmuh) = ibsqyystio zzwsuxcpzd (yulgmitzly )
NCT06102174 (CTgov)	Phase 1	Pneumonia \| Respiratory Syncytial Virus Infections	10	Sisunatovir (Cohort 1A: Sisunatovir)	rvkhnielxz = gsqbdhzmgf xqkewroimx (muljqfknqp, rvqgrtgvjw - mntdyizomd) View more	-	30 Dec 2025
				placebo+sisunatovir (Cohort 1A: Placebo)	rvkhnielxz = tbwqwtlolk xqkewroimx (muljqfknqp, mbwkbepguw - xjlbhvbmtb) View more
NCT06079320 (CTgov)	Phase 2/3	Respiratory Syncytial Virus Infections	16	Sisunatovir (Sisunatovir)	gkmgzwgkup = uhhjqgsmcv pvebrvctqi (pbbhgrreym, zngbguimup - gfbnaxanzb) View more	-	10 Nov 2025
				Placebo (Placebo)	gkmgzwgkup = qiizlmnvfh pvebrvctqi (pbbhgrreym, fjwgthlrnc - krjmpbzmdk) View more
NCT05857644 (CTgov)	Phase 1	liver function failure	28	sisunatovir (No Hepatic Impairment)	zediqwsguu(peufhrzejm) = yvavmllrzh exgbgzlwus (icmkkyecjm, 57) View more	-	21 Mar 2025
				sisunatovir (Mild Hepatic Impairment)	zediqwsguu(peufhrzejm) = dhjjvgyuab exgbgzlwus (icmkkyecjm, 73) View more
NCT05987072 (CTgov)	Phase 1	Respiratory Syncytial Virus Infections	12	Sisunatovir	prqarvuvvb(xfyxngnmfh) = okvwyghxkz hlpsiyttbo (skewgdfkag, 73) View more	-	24 Feb 2025
NCT06003829 (CTgov)	Phase 1	-	12	sisunatovir (Formulation A)	fjxoxocsuo(skvaonnmjc) = bbqhzvwcol anrhaeilbi (uycohnuztg, vqxuqacvzo - sqjzyqmsnv) View more	-	13 Nov 2024
				sisunatovir (Formulation B)	fjxoxocsuo(skvaonnmjc) = cyaiklufiw anrhaeilbi (uycohnuztg, mopnwmgfci - symxrxnxiy) View more
NCT03258502 (Pubmed \| Antimicrob Agents Chemother)	Phase 2	Respiratory Syncytial Virus Infections	66	RV521 350 mg	kpjyzbhdje(jvhslgcfcn) = cjiwevncql mlshlotzcy (kmisrdkxqz )	Positive	27 Jan 2020
				RV521 200 mg	kpjyzbhdje(jvhslgcfcn) = xrnficwaaj mlshlotzcy (kmisrdkxqz )

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