KalVista Pharmaceuticals, Inc. is a clinical stage pharmaceutical company, which engages in the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need. Its product candidates are inhibitors of plasma kallikrein being developed for two indications: Sebetralstat for HAE and Factor XIIa. The company was founded by T. Andrew Crockett, Edward P. Feener, and Lloyd Paul Aiello on March 26, 2004 and is headquartered in Cambridge, MA.
Clinical Trials
18
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2011
Active, not recruiting
1
5.6%
Available
1
5.6%
Completed
12
66.7%
Recruiting
2
11.1%
Terminated
1
5.6%
Unknown
1
5.6%
No approval data available
- The FDA approved three new hereditary angioedema treatments in just three months during 2025: CSL's Andembry in June, KalVista's Ekterly in July, and Ionis's Dawnzera in August. - These approvals represent breakthrough innovations including the first factor XIIa inhibitor, first oral on-demand therapy, and first RNA-targeting treatment for HAE prevention. - The rapid succession of approvals brings the total number of FDA-approved HAE treatments from 9 to 12, offering unprecedented treatment options for the estimated 7,000 U.S. patients. - Despite the therapeutic advances, significant unmet needs remain, particularly for pediatric patients under 12 years old, as 85% of HAE patients develop symptoms before age 20.
- The FDA approved three novel hereditary angioedema (HAE) therapies in 2025 after four years without new approvals, increasing total marketed drugs by 38% to 11 products. - CSL Behring's garadacimab became the first FDA-approved drug targeting coagulation factor XII, offering a new biological mechanism for HAE prevention. - KalVista's sebetralstat (Ekterly) represents the first oral on-demand treatment for HAE, providing patients with rapid relief during acute episodes. - Ionis Pharma's donidalorsen sodium introduced the first antisense oligonucleotide for HAE with extended dosing intervals of every four to eight weeks.
- DelveInsight's 2025 pipeline report reveals over 20 companies are actively developing more than 30 therapeutic candidates for hereditary angioedema treatment across various clinical stages. - Recent clinical developments include CSL Behring's Phase 3b study of garadacimab (CSL312) announced in August 2025 and KalVista's pediatric trial of KVD900 for patients aged 2-11 years. - Leading pipeline therapies span multiple approaches including oral plasma kallikrein inhibitors, gene therapies, and monoclonal antibodies, with products in late-stage development showing promise for addressing unmet medical needs.
- The FDA has extended its review of KalVista's sebetralstat for hereditary angioedema by four weeks past the June 17 deadline due to heavy workload and limited resources. - Sebetralstat would become the first on-demand oral treatment for hereditary angioedema if approved, offering a convenient alternative to injectable therapies. - The delay represents the first instance directly attributed to FDA resource constraints following agency restructuring under the Trump administration. - KalVista maintains confidence in near-term approval as the FDA has not requested additional data or raised safety concerns.
- The FDA will not meet the June 17, 2025 PDUFA goal date for KalVista's sebetralstat NDA due to heavy workload and limited resources, with a decision expected within four weeks. - Sebetralstat represents a potential breakthrough as the first oral on-demand treatment for hereditary angioedema attacks in patients aged 12 and older. - The FDA has not requested additional data or raised safety concerns, with only labeling finalization remaining under review according to KalVista. - The delay affects patients with hereditary angioedema who currently rely on intravenous or subcutaneous treatments for managing painful and potentially life-threatening attacks.
- KalVista Pharmaceuticals reported that sebetralstat, an investigational oral plasma kallikrein inhibitor, halted hereditary angioedema attack progression in a median time of 19.8 minutes across both KONFIDENT and KONFIDENT-S trials. - The drug demonstrated rapid efficacy in treating severe mucosal attacks, with patients achieving symptom relief in 1.3 hours for both abdominal and laryngeal attacks, and 96% of attacks resolved without requiring additional doses. - Clinical data showed sebetralstat effectively treated 76 severe or very severe HAE attacks that had progressed after delayed treatment, delivering symptom relief in a median of 1.36 hours. - The oral formulation represents a potential breakthrough as the first oral on-demand HAE treatment, with regulatory review ongoing and a FDA PDUFA goal date of June 17, 2025.
- KalVista Pharmaceuticals has completed enrollment in the KONFIDENT-KID trial of sebetralstat, an oral plasma kallikrein inhibitor for children aged 2-11 with hereditary angioedema, a full year ahead of schedule. - Due to overwhelming interest from families affected by HAE, the trial was expanded from 24 to nearly 36 children across seven countries in Asia, Europe, and North America. - If approved, sebetralstat would become the first oral on-demand therapy for pediatric HAE patients, with initial results expected later this year and a supplemental New Drug Application planned by mid-2026.
- Intellia Therapeutics has initiated Phase 3 trials for NTLA-2002, a groundbreaking CRISPR-based gene therapy for hereditary angioedema, with potential U.S. launch targeted for 2027. - KalVista Pharmaceuticals' sebetralstat receives Orphan Drug Designation in Japan, marking progress toward the first oral on-demand treatment for HAE attacks. - The global angioedema pipeline includes 20+ companies developing innovative therapies, with several promising candidates in late-stage development from companies like ADARx, BioMarin, and Astria Therapeutics.
- KalVista Pharmaceuticals will present new sebetralstat data at multiple upcoming medical conferences, including findings on the oral drug's effectiveness for laryngeal and mucosal hereditary angioedema attacks. - The presentations will showcase interim analysis from the KONFIDENT-S trial and pooled data from adolescent patients, highlighting sebetralstat's potential as the first oral on-demand HAE treatment. - Sebetralstat remains under FDA regulatory review with a PDUFA goal date of June 17, 2025, representing a potential breakthrough for HAE patients who currently rely on injectable treatments.
- New data from the KONFIDENT-S trial demonstrates sebetralstat's effectiveness in treating HAE attacks, with patients achieving symptom relief within 1.3 hours and treatment initiation within 6-20 minutes. - Sebetralstat proved well-tolerated in patients receiving various long-term prophylaxis treatments, including berotralstat, potentially transforming HAE management for those preferring needle-free options. - KalVista Pharmaceuticals awaits FDA review of sebetralstat with a PDUFA date of June 17, 2025, positioning it to potentially become the first oral on-demand treatment for HAE patients aged 12 and older.
