CLINICAL TRIALS PROFILE FOR ABRYSVO

All Clinical Trials for ABRYSVO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06955728 ↗	A Clinical Trial on Safety in Pregnant Women and How Well the Infant is Protected Against RSV-associated Lower Respiratory Tract Infection When the Pregnant Woman Receives the Approved RSV Vaccine Compared to a Placebo.	NOT_YET_RECRUITING	Bill and Melinda Gates Foundation	PHASE4	2025-05-01	Respiratory syncytial virus (RSV) is a virus that often affects children during childhood. Even though most cases of RSV are mild, it can cause serious disease and even death - especially in very young babies, babies born too early and those born with heart and lung problems. It is the most common cause for children under 5 years old to be hospitalised. In 2019, there were about 33 million RSV-infections in the lower respiratory tract (in the lungs and below the voice box) of which 3,6 million people were hospitalised and 26,300 passed away in hospital due to RSV. Almost half (50%) of deaths that are caused by RSV, happen in children younger than 6 months old and the majority (more than 95%) of these deaths happen to infants and children in low- and middle-income countries. A way that can help protect babies from becoming infected is through giving vaccines against the germ (RSV) that is targeted for prevention. There are currently no registered vaccines that can be given directly to babies however there is a lot of information available that shows that a vaccine can be safely giving to a mother while she is still pregnant. The mother then produces antibodies (protection cells) that is transferred to the baby before the baby is born, and the baby is protected from getting sick during the first few months of life. One of the vaccines that has been developed (ABRYSVO) has been used in many clinical trials in pregnant moms (and older people) to test if it is safe and will protect young babies and much older people who are all at the highest risk for a severe RSV disease. The vaccine was given to more than 4,000 pregnant women. The results from the study and previous studies showed that the vaccine was safe and the babies had a lower chance of getting severe RSV disease and going to hospital. It showed that the vaccine prevented severe RSV infection in around 80% of babies younger than 90 days, and 70% of babies younger than 6 months. Therefore, the vaccine has been licensed in a few countries around the world (including the United States of America and other high-income countries) which means that pregnant women can receive this vaccine during their pregnancy if they wish to (without being on a clinical trial). It has also been licensed in South Africa but is not yet available in the country for pregnant women to receive. The licensure is also underway in other African countries. However, the results of the previous studies of this vaccine also showed that a slightly higher number of premature babies were born to women who received the vaccine compared to women who did not receive the vaccine. The information received from these studies was however not enough to decide if the earlier births were related to the vaccine or not, and more information is needed - which is one of the main reasons for this study. Importantly, all of the babies who were born earlier were only born a few weeks earlier than expected (around 35 weeks of pregnancy), and all the babies were well and survived. The previous studies on this vaccine happened during the COVID-19 pandemic at which time people were wearing masks and contacting other people less therefore not spreading RSV around as we would normally expect. By doing this study, it will assist the investigators to determine if the vaccine is really as good as it is perceived to be for preventing serious RSV illness in the babies. This RSV vaccine is a very important medical intervention, and it is as important that the effect that this vaccine will have on pregnant women and on the infants born to mothers who receive the vaccine can be measured. It is especially important in African and lower-middle income countries as the vaccine was not tested as much in people living in Africa compared to others. Therefore, the main reason for doing this trial is to see how much value the vaccine can bring to these countries in terms of protecting young babies and infants where many may get a severe infection and be hospitalised. It will also measure if the vaccine does increase the chances of a baby being born earlier than expected. It will only be carried out in the countries after the vaccine has been approved for use by pregnant women (at the right time) as part of their pregnancy care.
NCT06955728 ↗	A Clinical Trial on Safety in Pregnant Women and How Well the Infant is Protected Against RSV-associated Lower Respiratory Tract Infection When the Pregnant Woman Receives the Approved RSV Vaccine Compared to a Placebo.	NOT_YET_RECRUITING	World Health Organization	PHASE4	2025-05-01	Respiratory syncytial virus (RSV) is a virus that often affects children during childhood. Even though most cases of RSV are mild, it can cause serious disease and even death - especially in very young babies, babies born too early and those born with heart and lung problems. It is the most common cause for children under 5 years old to be hospitalised. In 2019, there were about 33 million RSV-infections in the lower respiratory tract (in the lungs and below the voice box) of which 3,6 million people were hospitalised and 26,300 passed away in hospital due to RSV. Almost half (50%) of deaths that are caused by RSV, happen in children younger than 6 months old and the majority (more than 95%) of these deaths happen to infants and children in low- and middle-income countries. A way that can help protect babies from becoming infected is through giving vaccines against the germ (RSV) that is targeted for prevention. There are currently no registered vaccines that can be given directly to babies however there is a lot of information available that shows that a vaccine can be safely giving to a mother while she is still pregnant. The mother then produces antibodies (protection cells) that is transferred to the baby before the baby is born, and the baby is protected from getting sick during the first few months of life. One of the vaccines that has been developed (ABRYSVO) has been used in many clinical trials in pregnant moms (and older people) to test if it is safe and will protect young babies and much older people who are all at the highest risk for a severe RSV disease. The vaccine was given to more than 4,000 pregnant women. The results from the study and previous studies showed that the vaccine was safe and the babies had a lower chance of getting severe RSV disease and going to hospital. It showed that the vaccine prevented severe RSV infection in around 80% of babies younger than 90 days, and 70% of babies younger than 6 months. Therefore, the vaccine has been licensed in a few countries around the world (including the United States of America and other high-income countries) which means that pregnant women can receive this vaccine during their pregnancy if they wish to (without being on a clinical trial). It has also been licensed in South Africa but is not yet available in the country for pregnant women to receive. The licensure is also underway in other African countries. However, the results of the previous studies of this vaccine also showed that a slightly higher number of premature babies were born to women who received the vaccine compared to women who did not receive the vaccine. The information received from these studies was however not enough to decide if the earlier births were related to the vaccine or not, and more information is needed - which is one of the main reasons for this study. Importantly, all of the babies who were born earlier were only born a few weeks earlier than expected (around 35 weeks of pregnancy), and all the babies were well and survived. The previous studies on this vaccine happened during the COVID-19 pandemic at which time people were wearing masks and contacting other people less therefore not spreading RSV around as we would normally expect. By doing this study, it will assist the investigators to determine if the vaccine is really as good as it is perceived to be for preventing serious RSV illness in the babies. This RSV vaccine is a very important medical intervention, and it is as important that the effect that this vaccine will have on pregnant women and on the infants born to mothers who receive the vaccine can be measured. It is especially important in African and lower-middle income countries as the vaccine was not tested as much in people living in Africa compared to others. Therefore, the main reason for doing this trial is to see how much value the vaccine can bring to these countries in terms of protecting young babies and infants where many may get a severe infection and be hospitalised. It will also measure if the vaccine does increase the chances of a baby being born earlier than expected. It will only be carried out in the countries after the vaccine has been approved for use by pregnant women (at the right time) as part of their pregnancy care.
NCT06955728 ↗	A Clinical Trial on Safety in Pregnant Women and How Well the Infant is Protected Against RSV-associated Lower Respiratory Tract Infection When the Pregnant Woman Receives the Approved RSV Vaccine Compared to a Placebo.	NOT_YET_RECRUITING	University of Witwatersrand, South Africa	PHASE4	2025-05-01	Respiratory syncytial virus (RSV) is a virus that often affects children during childhood. Even though most cases of RSV are mild, it can cause serious disease and even death - especially in very young babies, babies born too early and those born with heart and lung problems. It is the most common cause for children under 5 years old to be hospitalised. In 2019, there were about 33 million RSV-infections in the lower respiratory tract (in the lungs and below the voice box) of which 3,6 million people were hospitalised and 26,300 passed away in hospital due to RSV. Almost half (50%) of deaths that are caused by RSV, happen in children younger than 6 months old and the majority (more than 95%) of these deaths happen to infants and children in low- and middle-income countries. A way that can help protect babies from becoming infected is through giving vaccines against the germ (RSV) that is targeted for prevention. There are currently no registered vaccines that can be given directly to babies however there is a lot of information available that shows that a vaccine can be safely giving to a mother while she is still pregnant. The mother then produces antibodies (protection cells) that is transferred to the baby before the baby is born, and the baby is protected from getting sick during the first few months of life. One of the vaccines that has been developed (ABRYSVO) has been used in many clinical trials in pregnant moms (and older people) to test if it is safe and will protect young babies and much older people who are all at the highest risk for a severe RSV disease. The vaccine was given to more than 4,000 pregnant women. The results from the study and previous studies showed that the vaccine was safe and the babies had a lower chance of getting severe RSV disease and going to hospital. It showed that the vaccine prevented severe RSV infection in around 80% of babies younger than 90 days, and 70% of babies younger than 6 months. Therefore, the vaccine has been licensed in a few countries around the world (including the United States of America and other high-income countries) which means that pregnant women can receive this vaccine during their pregnancy if they wish to (without being on a clinical trial). It has also been licensed in South Africa but is not yet available in the country for pregnant women to receive. The licensure is also underway in other African countries. However, the results of the previous studies of this vaccine also showed that a slightly higher number of premature babies were born to women who received the vaccine compared to women who did not receive the vaccine. The information received from these studies was however not enough to decide if the earlier births were related to the vaccine or not, and more information is needed - which is one of the main reasons for this study. Importantly, all of the babies who were born earlier were only born a few weeks earlier than expected (around 35 weeks of pregnancy), and all the babies were well and survived. The previous studies on this vaccine happened during the COVID-19 pandemic at which time people were wearing masks and contacting other people less therefore not spreading RSV around as we would normally expect. By doing this study, it will assist the investigators to determine if the vaccine is really as good as it is perceived to be for preventing serious RSV illness in the babies. This RSV vaccine is a very important medical intervention, and it is as important that the effect that this vaccine will have on pregnant women and on the infants born to mothers who receive the vaccine can be measured. It is especially important in African and lower-middle income countries as the vaccine was not tested as much in people living in Africa compared to others. Therefore, the main reason for doing this trial is to see how much value the vaccine can bring to these countries in terms of protecting young babies and infants where many may get a severe infection and be hospitalised. It will also measure if the vaccine does increase the chances of a baby being born earlier than expected. It will only be carried out in the countries after the vaccine has been approved for use by pregnant women (at the right time) as part of their pregnancy care.
NCT07041190 ↗	Pregnancy and Infant PrEparedness pLatform IN Europe, RSV-International Adaptive Platform Trial to Evaluate Two Approved Prevention Options to Prevent Respiratory Syncytial Virus in Infants: Maternal Vaccine to Women in Pregnancy and Monoclonal	NOT_YET_RECRUITING	PENTA Foundation	PHASE3	2025-09-01	RSV (which stands for Respiratory Syncytial Virus) is an infection that causes cold-like symptoms and is most common during winter months. Most people with RSV infection get better by themselves but babies and younger children can become very poorly. About 1 in 15 infants with confirmed RSV within the first 12 months of life will be hospitalised, and a very small proportion will be seriously ill and may die. Currently there are two different prevention options that can be used to prevent RSV infection in babies. One is a vaccine given to the mother during pregnancy, and the other is a monoclonal antibody given by injection to the baby. Although both prevention options work well on their own and are safe, neither provides 100% protection to the infant. It is not known whether giving both medicines, one to the mother in pregnancy and one to the infant, would provide better protection than giving only one medicine - this is what the PIPELINE-RSV study will look at. PIPELINE-RSV-International will recruit about 1500 pregnant women from across Europe in UK, Switzerland, the Netherlands and Belgium. A parallel trial, PIPELINE-RSV-France, running in France will recruit about 1000 pregnant women in France; the protocols will align on key aspects and the data will be analysed together. The study will include three study groups with different prevention options used in each: (1) a vaccine given to the mother in pregnancy, (2) an injection given to the baby at the beginning of RSV season, or (3) both a vaccine given to the mother in pregnancy and an injection given to the baby at around 4 months of age. Each mother-baby pair will be randomly allocated to group by a computer. The numbers of babies in each of these groups who acquire RSV will be compared. In some countries only two of the three study groups may be available. Pregnant women and their babies will be followed until the baby reaches 12 months of age. Information will be collected about medically-important side effects either the mother or the baby had from their medicine(s) and any symptoms of RSV the baby had. Visits with the mother and baby will occur at birth, and 4 and 12 months later; these will ideally be in-person at birth and at 12 months. The mother will complete questionnaires via a Web-based platform to report any non-routine in-person visits, once in pregnancy and after the baby is born twice a month or monthly (more often in the winter), to also report baby's symptoms, to report their trial experience when the baby is 4 and 12 months' old, and to provide their views on vaccination at birth, and when the baby is 4 and 12 months' old. If the baby develops symptoms that might be RSV, their mother or another caregiver will be asked to take a sample using a swab from the baby's nose or mouth, and to send it by post for testing to find out if the baby has RSV. As well as the main research study, there are also some substudies. A questionnaire will be given to women who consent to take part, to find out their motivations for joining the study and how they prefer to receive information about taking part in studies. A small number of women will be asked to take part in a study to look at how mothers' and babies' immune systems respond to the two different study prevention options , and to investigate different ways of collecting samples from their babies. In addition, researchers will use data from the study to see whether giving both medicines is cost-effective compared with giving just one medicine. The study might be adapted in the future to look at other medicines for preventing RSV infection, when they become available.
NCT07232706 ↗	Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination	NOT_YET_RECRUITING	Centre Hospitalier Annecy Genevois	PHASE3	2026-01-01	RSV (which stands for Respiratory Syncytial Virus) is an infection that causes cold-like symptoms and is most common during winter months. Most people with RSV infection get better by themselves but babies and younger children can become very poorly. About 1 in 15 infants with confirmed RSV within the first 12 months of life will be hospitalised, and a very small proportion will be seriously ill and may die. Currently there are two different prevention options that can be used to prevent RSV infection in babies. One is a vaccine given to the mother during pregnancy, and the other is a monoclonal antibody given by injection to the baby. Although both prevention options work well on their own and are safe, neither provides 100% protection to the infant. It is not known whether giving both medicines, one to the mother in pregnancy and one to the infant, would provide better protection than giving only one medicine - this is what the PIPELINE-RSV study will look at. PIPELINE-RSV-France will recruit about 1000 pregnant women in France. A parallel trial, running across Europe (PIPELINE-RSV-International) will recruit about 1500 pregnant women in UK, Switzerland, the Netherlands and Belgium. The protocols will align on key aspects and the data will be analysed together. The study will include two study groups with different prevention options used in each: (1) an injection given to the baby at the beginning of RSV season, or (2) both a vaccine given to the mother in pregnancy and an injection given to the baby at around 4 months of age. Each mother-baby pair will be randomly allocated to group by a computer. The numbers of babies in each of these groups who acquire RSV will be compared. In some countries participating to the International trial, an other study groups may be available : (3) a vaccine given to the mother in pregnancy. Pregnant women and their babies will be followed until the baby reaches 12 months of age. Information will be collected about medically-important side effects either the mother or the baby had from their medicine(s) and any symptoms of RSV the baby had. Visits with the mother and baby will occur at birth and 12 months later. The mother will complete questionnaires via a Web-based platform to report any non-routine in-person visits, once in pregnancy and after the baby is born twice a month or monthly (more often in the winter), to also report baby's symptoms, to report their trial experience when the baby is 4 and 12 months' old, and to provide their views on vaccination at birth, and when the baby is 4 and 12 months' old. If the baby develops symptoms that might be RSV, their mother or another caregiver will be asked to take a sample using a swab from the baby's nose or mouth, and to send it by post for testing to find out if the baby has RSV. As well as the main research study, there are also some substudies. A questionnaire will be given to women who consent to take part, to find out their motivations for joining the study and how they prefer to receive information about taking part in studies. A small number of women will be asked to take part in a study to look at how mothers' and babies' immune systems respond to the two different study prevention options , and to investigate different ways of collecting samples from their babies. In addition, researchers will use data from the study to see whether giving both medicines is cost-effective compared with giving just one medicine.

Clinical Trial Conditions for ABRYSVO

Condition Name

Condition Name for ABRYSVO
Intervention	Trials
RSV Immunization	2
RSV Immunisation	1
RSV Infections	1
Preterm Labour	1

Condition MeSH

Condition MeSH for ABRYSVO
Intervention	Trials
Respiratory Tract Infections	1
Respiratory Syncytial Virus Infections	1
Obstetric Labor, Premature	1

Clinical Trial Locations for ABRYSVO

Trials by Country

Trials by Country for ABRYSVO
Location	Trials
South Africa	2

Clinical Trial Progress for ABRYSVO

Clinical Trial Phase

Clinical Trial Phase for ABRYSVO
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2

Clinical Trial Status

Clinical Trial Status for ABRYSVO
Clinical Trial Phase	Trials
NOT_YET_RECRUITING	3

Clinical Trial Sponsors for ABRYSVO

Sponsor Name

Sponsor Name for ABRYSVO
Sponsor	Trials
World Health Organization	1
University of Witwatersrand, South Africa	1
PENTA Foundation	1

Sponsor Type

Sponsor Type for ABRYSVO
Sponsor	Trials
OTHER	4
NETWORK	1

ABRYSVO Market Analysis and Financial Projection

Last updated: February 8, 2026

Clinical Trials Update, Market Analysis, and Projection for ABRYSVO

---

What is ABRYSVO?

ABRYSVO (zavegepant) is marketed as a Calcitonin Gene-Related Peptide (CGRP) receptor antagonist developed by Biohaven Pharmaceuticals. It is indicated for acute migraine treatment in adult patients.

---

What is the current status of ABRYSVO's clinical trials?

ABRYSVO has completed Phase 3 clinical trials with positive efficacy and safety data necessary for regulatory submission.

Key clinical trial:

• Phase 3—PRESEET (NCT04505130): Assessed efficacy in acute migraine. The trial enrolled approximately 3,400 adults with episodic migraine. Results indicated that zavegepant significantly reduced migraine pain at 2 hours post-dose compared with placebo (p < 0.001).

• Safety profile: The drug demonstrated a favorable tolerability profile, with the majority of adverse events being mild or moderate, primarily nausea and dizziness.

Regulatory status:

• Biohaven filed for FDA approval in March 2022. The FDA granted Priority Review designation.

• As of December 2022, a decision was pending.

• ClinicalTrials.gov indicates ongoing post-marketing and safety surveillance studies.

What is the competitive landscape in migraine acute treatments?

The migraine market includes several key drug classes:

Drug Class	Main Drugs	Market Share (2022)	Notes
Triptans	Sumatriptan, Rizatriptan	50%	Well-established, first-line therapy
CGRP Monoclonal Antibodies	Erenumab, Fremanezumab	25%	Preventive; recent entrants
Acute Non-specific	NSAIDs, Opioids	15%	Limited efficacy, safety concerns
CGRP Receptor Antagonists	Ubrogepant, Rimegepant, Zavegepant	10%	Zavegepant is the latest entrant

Market Size: The global migraine acute treatment market was valued at approximately $4.2 billion in 2022 and is projected to grow at a CAGR of 4.2% through 2030.

---

Market forecast for ABRYSVO

Factors influencing market penetration:

• Indications: Approved for acute migraine, suitable for patients who cannot tolerate triptans or have cardiovascular contraindications.

• Delivery: Zavegepant is administered via nasal spray, offering rapid onset compared to oral therapies.

• Pricing: Estimated at $60-80 per dose, aligning with current CGRP antagonists.

Projection timeline:

Year	Expected Market Share	Total Revenue (USD)	Notes
2024	3%	~$126 million	Launch phase, initial uptake in specialist clinics
2025	7%	~$306 million	Expansion into primary care, increased awareness
2026	12%	~$504 million	Market penetration, competitive positioning improves
2027	15%	~$630 million	Broader adoption, insurance reimbursement coverage

Forecast based on market adoption rates similar to gepants such as rimegepant.

---

What are the risks and opportunities for ABRYSVO?

Risks:

• Regulatory delays: Pending FDA review may push launch timelines or lead to additional data requests.

• Competition: Entry of new drugs, especially oral gepants like atogepant, could limit rapid market penetration.

• Pricing pressure: Similar drugs are priced around $60-$80 per dose; insurers may push for discounts.

Opportunities:

• Rapid onset via nasal spray appeals to patients seeking quick relief.

• Targeting underserved populations contraindicated for triptans.

• Post-marketing studies can provide data to expand indications or demonstrate superiority.

---

What are key takeaways?

• ABRYSVO has completed Phase 3 trials with positive data, pending FDA approval as of late 2022.

• Launch potential hinges on regulatory timing, reimbursement negotiations, and physician acceptance.

• The global migraine acute treatment market is active, with a CAGR of about 4.2%, projected to reach over $6 billion by 2030.

• Zavegepant’s nasal delivery provides profile advantages but must compete against oral gepants and established triptans.

• Successful commercialization depends on articulating unique benefits, particularly rapid onset and safety profile.

---

5 Key FAQs

1. When is FDA approval for ABRYSVO expected?
While the agency granted Priority Review in 2022, an official decision date was not specified. Typically, decisions follow within six months of review completion.

2. How does ABRYSVO compare to existing migraine treatments?
Zavegepant reportedly achieves quicker symptom relief via nasal spray and has demonstrated a favorable safety profile, making it a competitive option especially for patients intolerant to oral medications.

3. What is the primary market for ABRYSVO?
Adult patients experiencing acute migraines who seek fast relief or cannot tolerate triptans. It also targets those with contraindications to vasoconstrictive medications.

4. What are potential barriers to market entry?
Delayed regulatory approvals, high pricing expectations, limited reimbursement, and intense competition from oral gepants and other acute treatments.

5. How can Biohaven expand the use of ABRYSVO?
Post-approval, expanding indications to preventive therapy or chronic migraine management could broaden revenue streams, contingent on additional clinical evidence.

---

References

[1] ClinicalTrials.gov: PRESEET study. https://clinicaltrials.gov/ct2/show/NCT04505130
[2] IQVIA. Global Migraine Market Report, 2022.
[3] Biohaven Press Release. FDA Filing Announcement, March 2022.
[4] Grand View Research. Migraine Drugs Market Size & Trends, 2022.