Zero ad trackers.We never sell your data.
Bradykinin B2 receptor antagonist (small molecule, oral)

Deucrictibant

An investigational treatment for Hereditary Angioedema.

Phase 3by Pharvaris
Preclinical
Phase 1
Phase 2
Phase 3
Approved

Drug facts

The same compound appears under different names depending on the context. Here is how to identify Deucrictibant wherever you encounter it, plus the key facts at a glance.

Generic name
Deucrictibant
Development code
PHA-022121
Drug class
Bradykinin B2 receptor antagonist (small molecule, oral)
Manufacturer
Pharvaris
How it's taken
Capsule by mouth when an attack starts, under FDA review

An investigational capsule swallowed to treat hereditary angioedema (HAE) attacks as they happen, studied in people 12 and older[4].

  • The FDA accepted Pharvaris's New Drug Application for the 20mg immediate-release capsule for on-demand treatment and set a target action date of April 23, 2027[1].
  • In the Phase 3 RAPIDe-3 trial, symptom relief began after a median of 1.28 hours with deucrictibant, against more than 12 hours with placebo[4].
  • Pharvaris is separately testing a once-daily extended-release tablet to prevent attacks, and that tablet is not part of the current FDA review[1][2].
Email me the day the FDA decides on Deucrictibant

The decision is expected by April 23, 2027. One email when it is public, with what it means in plain language, plus new trials for Hereditary Angioedema and FDA news. Unsubscribe anytime.

You'll get, for Hereditary Angioedema:
  • Trial Alerts, when a new trial opens or a trial changes
  • Disease Updates, FDA decisions and condition news, usually 1 or 2 emails a month
Turn either off anytime from the link in every email.

We never share your email. Unsubscribe anytime. Privacy policy · Check any health site

Where Deucrictibant fits

Deucrictibant is an investigational capsule under FDA review for treating HAE attacks as they start, which Pharvaris says would make it the first oral bradykinin B2 receptor blocker for HAE attacks[1].

  • The WAO/EAACI international guideline describes on-demand medicine for every HAE attack, with preventive treatment added for some patients[14].
  • Approved on-demand options in the US include icatibant (Firazyr and generics), a self-injection that blocks the same receptor, for adults 18 and older, Kalbitor (ecallantide), an injection given by a health care professional from age 12, the C1 inhibitor infusions Berinert and Ruconest, and Ekterly (sebetralstat), a tablet from age 12[15][16][17][18][14].
  • Approved preventive options include Takhzyro, Orladeyo, Andembry, Dawnzera and the C1 inhibitor concentrates Cinryze and Haegarda, and Pharvaris's separate extended-release deucrictibant tablet is being studied for prevention outside this FDA review[19][20][21][22][14][2].
  • Deucrictibant has not been compared head to head with icatibant, Ekterly or any other on-demand treatment, since RAPIDe-3 compared it only with placebo[4].
  • A person with HAE can ask their allergist or immunologist how an on-demand capsule would fit with the medicine they carry now, and whether any of their current medicines act on CYP3A4, the liver enzyme the trials screened for.

How Deucrictibant works

In HAE, the body either lacks enough working C1 inhibitor or, in a less common form called HAE with normal C1 inhibitor, has a change in another gene such as F12. In both cases the result is too much bradykinin, a small protein that makes blood vessels leak fluid into nearby tissue and causes swelling[13]. Bradykinin causes that swelling by attaching to the bradykinin B2 receptor[15].

Deucrictibant blocks the B2 receptor, so bradykinin cannot send its signal[4]. Icatibant (Firazyr) blocks the same receptor but is injected under the skin[15], while deucrictibant is a capsule taken by mouth[4]. Pharvaris's Phase 3 trials enrolled people with HAE type 1, type 2 and HAE with normal C1 inhibitor[4][2].

Clinical trial results

RAPIDe-3 (NCT06343779) was a Phase 3, double-blind, placebo-controlled crossover trial at 59 sites in 24 countries[4]. It randomized 134 people aged 12 to 75 with HAE, 10 of them adolescents, including people with normal C1 inhibitor and a documented gene variant, who had at least 2 attacks in the 3 months before screening[4]. People on a preventive medicine could join if they stayed on a stable dose[7].

In the 88 people who treated 1 attack with each, symptom relief began after a median of 1.28 hours on deucrictibant and more than 12 hours on placebo[4]. Pharvaris reported that the trial met all 11 secondary efficacy goals, with median times on deucrictibant of 17.48 minutes until symptoms stopped getting worse and 11.95 hours until they fully resolved[1].

The results were published in The Lancet in October 2026[4]. RAPIDe-2 (NCT05396105), an open-label extension, follows long-term on-demand use[10].

CHAPTER-3 (NCT06669754) tested a different form, a 40mg extended-release tablet taken once a day to prevent attacks, against placebo for 24 weeks in 85 people 12 and older with any of the 3 types of HAE[2]. Pharvaris reported on September 8, 2026 that the monthly attack rate was 83% lower than on placebo, 87% lower in the 80 people with HAE type 1 or type 2, and that all secondary goals were met[2].

Full CHAPTER-3 results had not been published in a journal as of November 7, 2026. The tablet is not part of the current FDA application, and Pharvaris said on September 8, 2026 that it planned to submit a New Drug Application to the FDA for preventing attacks in the first half of 2027, with applications in other regions starting in the same period[2]. CHAPTER-4 (NCT06679881) is an open-label extension of the tablet[9].

Main registered trial: NCT06343779 on ClinicalTrials.gov. Check it for the current status, sites and contacts before asking about enrollment.

Side effects and safety

Early trial safety observations

Deucrictibant has no US label yet, so its official side effects and warnings are not set. In RAPIDe-3, fatigue was the only side effect reported more than once in the 3 days after a dose, in 2 people, and 1 of those cases was judged unrelated to treatment[4]. No treatment-related side effects were rated severe or serious, and no side effect led anyone to stop treatment[4].

In the CHAPTER-3 prevention trial of the daily tablet, Pharvaris reported that most side effects were mild or moderate, none of the serious ones were judged treatment-related, and 1 person in each group stopped because of a side effect[2]. The trials left out people with abnormal liver function, reduced kidney function, pregnancy or breastfeeding, and people taking medicines that strongly block or speed up CYP3A4, a liver enzyme that breaks down many drugs[7][8]. Any limits for these groups would be set by the FDA label.

This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.

Taking Deucrictibant

In RAPIDe-3, each treated attack got a single 20mg immediate-release capsule by mouth, and each person treated 1 attack with deucrictibant and 1 with placebo in random order[4]. The application under FDA review covers that 20mg capsule for on-demand treatment[1]. The separate extended-release tablet was tested at 40mg once a day to prevent attacks[8]. The US dose, including whether a second capsule may be taken for the same attack, would be set by the FDA label.

Development history

Pharvaris developed deucrictibant under the code PHA-022121[11]. Pharvaris says the FDA granted it orphan drug designation for bradykinin-mediated angioedema in 2022, and that the European Commission and Swissmedic have granted the same designation[1]. The Phase 2 RAPIDe-1 trial of on-demand use and the Phase 2 CHAPTER-1 trial of daily prevention were published in The Lancet Haematology in April 2026[5][6].

On July 6, 2026 Pharvaris announced that the FDA had accepted its New Drug Application for the 20mg immediate-release capsule, with a target action date of April 23, 2027[1]. In August 2026 Pharvaris said the European Medicines Agency had validated its application for on-demand use in July, and that it had opened an expanded access program for the capsule in the US[3][12].

CHAPTER-3 topline results followed on September 8, 2026[2], and RAPIDe-3 was published in The Lancet in October 2026[4]. Pharvaris has not disclosed a price. The FDA had not announced a decision as of November 7, 2026.

Ask anything about Deucrictibant
AI-powered answers from clinical trial databases, FDA reports, and medical literature
Start withor ask

Explore Hereditary Angioedema trials

Other Hereditary Angioedema treatments

Common questions about Deucrictibant

▸What is Deucrictibant?

An investigational capsule swallowed to treat hereditary angioedema (HAE) attacks as they happen, studied in people 12 and older[4]. The FDA accepted Pharvaris's New Drug Application for the 20mg immediate-release capsule for on-demand treatment and set a target action date of April 23, 2027[1]. In the Phase 3 RAPIDe-3 trial, symptom relief began after a median of 1.28 hours with deucrictibant, against more than 12 hours with placebo[4]. Pharvaris is separately testing a once-daily extended-release tablet to prevent attacks, and that tablet is not part of the current FDA review[1][2].

▸How does Deucrictibant work?

In HAE, the body either lacks enough working C1 inhibitor or, in a less common form called HAE with normal C1 inhibitor, has a change in another gene such as F12. In both cases the result is too much bradykinin, a small protein that makes blood vessels leak fluid into nearby tissue and causes swelling[13]. Bradykinin causes that swelling by attaching to the bradykinin B2 receptor[15]. Deucrictibant blocks the B2 receptor, so bradykinin cannot send its signal[4]. Icatibant (Firazyr) blocks the same receptor but is injected under the skin[15], while deucrictibant is a capsule taken by mouth[4]. Pharvaris's Phase 3 trials enrolled people with HAE type 1, type 2 and HAE with normal C1 inhibitor[4][2].

▸What are the side effects of Deucrictibant?

Deucrictibant has no US label yet, so its official side effects and warnings are not set. In RAPIDe-3, fatigue was the only side effect reported more than once in the 3 days after a dose, in 2 people, and 1 of those cases was judged unrelated to treatment[4]. No treatment-related side effects were rated severe or serious, and no side effect led anyone to stop treatment[4]. In the CHAPTER-3 prevention trial of the daily tablet, Pharvaris reported that most side effects were mild or moderate, none of the serious ones were judged treatment-related, and 1 person in each group stopped because of a side effect[2]. The trials left out people with abnormal liver function, reduced kidney function, pregnancy or breastfeeding, and people taking medicines that strongly block or speed up CYP3A4, a liver enzyme that breaks down many drugs[7][8]. Any limits for these groups would be set by the FDA label.

▸How is Deucrictibant taken?

In RAPIDe-3, each treated attack got a single 20mg immediate-release capsule by mouth, and each person treated 1 attack with deucrictibant and 1 with placebo in random order[4]. The application under FDA review covers that 20mg capsule for on-demand treatment[1]. The separate extended-release tablet was tested at 40mg once a day to prevent attacks[8]. The US dose, including whether a second capsule may be taken for the same attack, would be set by the FDA label.

▸Is Deucrictibant FDA approved?

Not yet. Deucrictibant is under FDA review for Hereditary Angioedema; Pharvaris has filed an application and a decision is due April 23, 2027. The FDA calendar page tracks the outcome.

▸Is deucrictibant FDA approved?

No. Deucrictibant is under FDA review and is not approved in the US.

Status: Pharvaris announced on July 6, 2026 that the FDA accepted its New Drug Application for the 20mg immediate-release capsule for on-demand treatment of HAE attacks.

Decision date: April 23, 2027.

Europe: Pharvaris said the European Medicines Agency validated its application in July 2026.

Before approval: Pharvaris lists a US expanded access program for people 12 to 75 whose doctor finds no satisfactory on-demand option.

Source: Pharvaris, July 6, 2026; ClinicalTrials.gov NCT07759141

▸How fast did deucrictibant work in the RAPIDe-3 trial?

Symptom relief began after a median of 1.28 hours with deucrictibant, against more than 12 hours with placebo.

Trial: 134 people aged 12 to 75 were randomized to treat 1 attack with a 20mg capsule and 1 with placebo; the main analysis covered the 88 who treated both.

Other measures: Pharvaris reported median times of 17.48 minutes until symptoms stopped getting worse and 11.95 hours until they fully resolved.

Safety: No treatment-related side effects were severe or serious.

Source: Riedl et al., The Lancet 2026

▸Can deucrictibant prevent HAE attacks?

A different form, a once-daily 40mg extended-release tablet, is being studied for prevention and is not part of the current FDA review.

CHAPTER-3: Pharvaris reported an 83% lower monthly attack rate than placebo over 24 weeks in 85 people 12 and older.

Publication: Full results had not been published in a journal as of November 7, 2026.

Next step: Pharvaris said on September 8, 2026 that it planned to submit a New Drug Application to the FDA for preventing attacks in the first half of 2027, with applications in other regions starting in the same period.

Source: Pharvaris, September 8, 2026

▸How is deucrictibant different from Firazyr (icatibant)?

Both block the bradykinin B2 receptor, and no trial has compared them directly.

Form: Firazyr is injected under the skin; deucrictibant is a capsule taken by mouth.

Ages: Firazyr is approved for adults 18 and older; RAPIDe-3 studied deucrictibant from age 12.

Status: Firazyr and generic icatibant are approved; deucrictibant is under FDA review.

Source: Firazyr label, DailyMed; Riedl et al., The Lancet 2026

Sources and references

Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.

  1. Pharvaris via GlobeNewswire (BioSpace copy) · 2026-07-06. Pharvaris Announces FDA Acceptance of New Drug Application for Deucrictibant IR for On-Demand Treatment of Hereditary Angioedema Attacks. https://www.biospace.com/press-releases/pharvaris-announces-fda-acceptance-of-new-drug-application-for-deucrictibant-ir-for-on-demand-treatment-of-hereditary-angioedema-attacks
  2. Pharvaris via GlobeNewswire (BioSpace copy) · 2026-09-08. Pharvaris Announces Positive Topline Data from CHAPTER-3 Pivotal Study of Deucrictibant XR for Prophylaxis of HAE Attacks. https://www.biospace.com/press-releases/pharvaris-announces-positive-topline-data-from-chapter-3-pivotal-study-of-deucrictibant-xr-for-prophylaxis-of-hae-attacks
  3. Pharvaris via GlobeNewswire (MassBio copy) · 2026-08-12. Pharvaris Reports Second Quarter 2026 Financial Results and Provides Business Update. https://www.massbio.org/news/member-news/pharvaris-reports-second-quarter-2026-financial-results-and-provides-business-update/
  4. The Lancet · 2026-10-24. Oral deucrictibant for on-demand treatment of hereditary angioedema attacks: a phase 3, multicentre, randomised, double-blind, placebo-controlled crossover trial. https://pubmed.ncbi.nlm.nih.gov/42849489/
  5. The Lancet Haematology · 2026-04. Oral deucrictibant for on-demand treatment of hereditary angioedema attacks (RAPIDe-1): a randomised, double-blind, placebo-controlled, phase 2 trial. https://pubmed.ncbi.nlm.nih.gov/41865747/
  6. The Lancet Haematology · 2026-04. Oral deucrictibant for prophylaxis of hereditary angioedema attacks (CHAPTER-1): primary analysis of a randomised, double-blind, placebo-controlled, phase 2 trial. https://pubmed.ncbi.nlm.nih.gov/41865746/
  7. ClinicalTrials.gov. Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema. https://clinicaltrials.gov/study/NCT06343779
  8. ClinicalTrials.gov. Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE. https://clinicaltrials.gov/study/NCT06669754
  9. ClinicalTrials.gov. Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE. https://clinicaltrials.gov/study/NCT06679881
  10. ClinicalTrials.gov. Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema. https://clinicaltrials.gov/study/NCT05396105
  11. ClinicalTrials.gov. Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema. https://clinicaltrials.gov/study/NCT04618211
  12. ClinicalTrials.gov. EAP for Deucrictibant Immediate-release. https://clinicaltrials.gov/study/NCT07759141
  13. MedlinePlus, National Library of Medicine. Hereditary angioedema: MedlinePlus Genetics. https://medlineplus.gov/genetics/condition/hereditary-angioedema/
  14. Allergy · 2022-07. The international WAO/EAACI guideline for the management of hereditary angioedema-The 2021 revision and update. https://pubmed.ncbi.nlm.nih.gov/35006617/
  15. U.S. National Library of Medicine, DailyMed · 2025-07-07. FIRAZYR (icatibant) injection: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ed6657ca-ab68-477a-9968-e12dc928b540
  16. U.S. National Library of Medicine, DailyMed · 2025-07-01. KALBITOR (ecallantide) injection: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f56aec67-c662-477c-b866-bfc23e8809cf
  17. U.S. National Library of Medicine, DailyMed · 2020-04-30. RUCONEST (C1 esterase inhibitor [recombinant]): prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=66d3fecb-32a4-7781-e053-2a91aa0a83ca
  18. U.S. National Library of Medicine, DailyMed · 2026-04-01. EKTERLY (sebetralstat) tablets: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d145e2f-8e7e-2e90-e063-6294a90a4449
  19. Takeda / FDA · 2026-08. TAKHZYRO (lanadelumab-flyo) injection, for subcutaneous use: US Prescribing Information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e8
  20. BioCryst / FDA · 2026-08. ORLADEYO (berotralstat) capsules and oral pellets: US Prescribing Information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3527ece1-e7e0-40b1-b0c5-6baeb0deabeb
  21. U.S. National Library of Medicine, DailyMed · 2025-06-30. ANDEMBRY (garadacimab-gxii) injection, for subcutaneous use: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07b0b671-db81-49f0-a402-0c0219db7fa2
  22. Ionis / FDA · 2025-09. DAWNZERA (donidalorsen) injection, for subcutaneous use: US Prescribing Information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ff501e0-f75f-07da-e063-6294a90a0cb7

This page is for informational purposes only and does not constitute medical advice. Drug information is sourced from public databases and peer-reviewed literature and may not reflect the most recent updates. Always discuss treatment options with your healthcare provider. Last reviewed: November 2026.

Follow Deucrictibant by email

We'll email you when the FDA acts on Deucrictibant and when new trials for Hereditary Angioedema open. Unsubscribe anytime.

You'll get, for Hereditary Angioedema:
  • Trial Alerts, when a new trial opens or a trial changes
  • Disease Updates, FDA decisions and condition news, usually 1 or 2 emails a month
Turn either off anytime from the link in every email.
We never share your email. Unsubscribe anytime. Privacy policy · Check any health site