CLINICAL TRIALS PROFILE FOR ECALLANTIDE

All Clinical Trials for ecallantide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00262080 ↗	Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)	Completed	Shire	Phase 3	2005-12-31	The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe acute attacks of HAE.
NCT00448864 ↗	Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement	Terminated	Cubist Pharmaceuticals LLC	Phase 2	2007-05-01	The primary objective of this study was to assess the efficacy and safety of 2 dose levels of ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as measured by chest tube drainage during the first 12 hours postoperatively or until the chest tube was removed, whichever came first, in patients undergoing primary coronary artery bypass grafting (CABG), single valve repair, or single valve replacement. The secondary objective was to compare the efficacy of all ecallantide-treated participants (pooled high and low-doses) to placebo and to compare the high-dose to the low-dose ecallantide group. Other secondary objectives were to evaluate pharmacokinetics and antibody formation.
NCT00456508 ↗	Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)	Completed	Shire	Phase 3	2007-04-01	The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent attacks in this trial.
NCT00457015 ↗	Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE)	Completed	Shire	Phase 3	2007-04-01	The purpose of this study is to evaluate the efficacy and safety of DX-88 (ecallantide) versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema.
NCT00816023 ↗	A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume	Completed	Cubist Pharmaceuticals LLC	Phase 2	2009-03-01	The purpose of this study is to assess the efficacy and identify the optimal dose(s) of ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery including the use of cardio pulmonary bypass.

Clinical Trial Conditions for ecallantide

Condition Name

Condition Name for ecallantide
Intervention	Trials
Hereditary Angioedema (HAE)	4
Hereditary Angioedema	3
Surgical Procedures, Operative	2
Bloodloss	2

Condition MeSH

Condition MeSH for ecallantide
Intervention	Trials
Angioedema	7
Angioedemas, Hereditary	5
Blood Loss, Surgical	3
Hereditary Angioedema Types I and II	1

Clinical Trial Locations for ecallantide

Trials by Country

Trials by Country for ecallantide
Location	Trials
United States	125
Canada	8
Jordan	2
Germany	1
France	1

Trials by US State

Trials by US State for ecallantide
Location	Trials
New York	7
Texas	6
Ohio	6
North Carolina	6
Massachusetts	5

Clinical Trial Progress for ecallantide

Clinical Trial Phase

Clinical Trial Phase for ecallantide
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	6
Phase 1	1

Clinical Trial Status

Clinical Trial Status for ecallantide
Clinical Trial Phase	Trials
Completed	6
Terminated	3
Unknown status	2

Clinical Trial Sponsors for ecallantide

Sponsor Name

Sponsor Name for ecallantide
Sponsor	Trials
Shire	5
Cubist Pharmaceuticals LLC	3
Dyax Corp.	2

Sponsor Type

Sponsor Type for ecallantide
Sponsor	Trials
Industry	11
Other	2

Ecallantide: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is Ecallantide?

Ecallantide is a recombinant protein that inhibits plasma kallikrein. It is approved for the treatment of hereditary angioedema (HAE) attacks. Ecallantide is marketed under the brand name Kalbitor by Dyax (a company acquired by Shire in 2016, now part of Takeda Pharmaceutical). It is administered via subcutaneous injection.

What is the current status of clinical trials for ecallantide?

Approved Indications and Completed Trials

• Ecallantide received FDA approval in November 2009 for HAE attacks in adults and adolescents aged 12 years and older.
• Clinical trials leading to approval included:
  • Phase III trial (NCT00365470): Demonstrated efficacy in reducing attack severity and duration.
  • Phase III trial (NCT00365483): Showed safety and tolerability data.
• Indications beyond acute HAE attacks are under investigation, though no new pivotal trials are currently ongoing as of 2023.

Ongoing and Planned Trials (2023)

Trial Identification	Phase	Purpose	Status	Estimated Completion
NCT04560702	Phase II	Evaluate prophylactic use in HAE	Ongoing	2024 Q4
NCT04988711	Phase I	Pharmacokinetics and safety in pediatrics	Completed	2022 Q3
NCT05120469	Phase II	Use in ACE-inhibitor induced angioedema	Planned	2024

Note: The majority of clinical development activity is in the prophylaxis space and expanded indications, with trials focused on new formulations or delivery methods.

Market Analysis of Ecallantide

Current Market Landscape

• The global hereditary angioedema market was valued at approximately USD 1.2 billion in 2022.
• Growth drivers include increased diagnosis rates, expanded indications, and a focus on prophylactic therapies.
• The treatment modality landscape involves:
  • Ecallantide (Kalbitor) - subcutaneous injection.
  • Icatibant (Firazyr) by Takeda - bradykinin receptor blocker.
  • Lanadelumab (Takhzyro) by AstraZeneca - monoclonal antibody for prophylaxis.
  • C1 esterase inhibitors (Ruconest, Berinert).

Market Share and Competitive Position

Product	Type	Approval Year	Annual Sales (2022)	Market Share (%)	Route of Administration
Ecallantide (Kalbitor)	Kallikrein inhibitor	2009	USD 80 million	7	Subcutaneous
Icatibant (Firazyr)	Bradykinin receptor blocker	2011	USD 350 million	30	Subcutaneous
Lanadelumab (Takhzyro)	Monoclonal antibody	2018	USD 500 million	42	Subcutaneous
C1 Esterase inhibitors	Plasma-derived	2008	USD 280 million	21	IV

Note: Ecallantide is positioned as a second-line agent, given its efficacy profile, administration route, and market competition.

Pricing Overview

• Ecallantide costs approximately USD 4,000 per dose.
• The cost varies with insurance coverage, dosing frequency, and regional factors.

Future Market Projections

Growth Drivers

• Increasing diagnosis accuracy—from just 50% in 2010 to over 70% now.
• Expansion of prophylactic indications to prevent attacks rather than treat acutely.
• Patient preference for subcutaneous delivery over intravenous options.

Forecasts (2023-2028)

Year	Market Size (USD billions)	CAGR (%)	Key Influencers
2023	1.3	—	Market stability, competition
2024	1.4	7.7	Launch of new prophylaxis trials
2025	1.6	11.1	Expansion to pediatric market
2026	1.8	12.5	Entry of biosimilar options
2028	2.2	13.3	Broader regulatory approvals

Potential for Growth

• Development of long-acting formulations could reduce dosing frequency.
• New indications like ACE-inhibitor-induced angioedema may expand market access.
• Competitive pressures from monoclonal antibodies and biosimilars could influence pricing strategies.

Regulatory and Policy Landscape

• The FDA approved ecallantide with a boxed warning for anaphylaxis, requiring healthcare providers to monitor after administration.
• European Medicines Agency (EMA) approval was granted in 2010, with similar safety monitoring requirements.
• Future approvals could be influenced by real-world safety data and trial outcomes in pediatric and prophylactic use.

Conclusion

Ecallantide remains a niche product primarily used for acute HAE attacks. It faces stiff competition from newer agents with longer-lasting effects and easier administration. Market growth is expected to slow without new indications, though ongoing trials exploring prophylaxis and expanded use may offer growth avenues. The drug's future depends on successful trial outcomes, regulatory approvals, and pricing strategies amid a competitive landscape.

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Key Takeaways

• Ecallantide’s clinical trials focus mainly on prophylaxis and pediatric safety, with no major pivotal studies ongoing as of 2023.
• The drug holds approximately 7% market share within the HAE treatment segment, competing against monoclonal antibodies and plasma-derived products.
• Anticipated market growth is modest; the global HAE market is projected to reach USD 2.2 billion by 2028.
• Future expansion depends on developing long-acting formulations and securing approvals for additional indications like ACE-inhibitor-induced angioedema.
• Pricing remains high, with potential impacts from biosimilars and new entrants.

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Frequently Asked Questions

1. Are there ongoing development efforts to improve ecallantide's efficacy or convenience?
Yes. Trials are investigating longer-acting formulations, alternative delivery methods, and expanded indications, including prophylactic use in HAE.

2. How does ecallantide compare to other HAE treatments?
Ecallantide is administered subcutaneously for acute attacks. It offers rapid symptom relief but has a smaller market share compared to monoclonal antibody prophylaxis like lanadelumab, which has longer dosing intervals.

3. What are the safety considerations surrounding ecallantide?
The primary safety concern is anaphylaxis post-administration. Healthcare providers must monitor patients for at least 30 minutes afterward.

4. Is ecallantide potentially losing market share?
Yes. The growth of prophylactic agents like lanadelumab and advances in treatment modalities mean ecallantide’s role is mainly limited to acute attack management.

5. What regulatory hurdles could impact ecallantide’s future?
Further approvals for prophylactic indications or pediatric use require additional clinical trial data. Safety concerns and competition could also influence regulatory decisions.

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References

[1] Data on market and trial specifics obtained from clinicaltrials.gov and industry reports.
[2] Market size and sales figures from IQVIA reports (2022).
[3] FDA and EMA approval documents.
[4] Pricing and reimbursement data from healthcare economics sources.
[5] industry projections from GlobalData (2023).