RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Overseas New Drugs Urgently Needed in Clinical Settings (China)

Structure/Sequence

Sequence Code 9658014

Source: *****

Clinical Trials associated with Conestat alfa

NCT06679426

/ Not yet recruitingPhase 3IIT

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study Evaluating the Safety and Efficacy of Conestat Alfa As a Treatment for Angiotensin-Converting Enzyme-Inhibitor-Induced Angioedema

Angiotensin-converting enzyme inhibitors (ACE-Is), prescribed most often to treat hypertension, have been used extensively since the 1980s. Additional indications for their use include heart failure, diabetes mellitus, chronic kidney disease, and post-myocardial infarction. It is estimated that up to 40 million patients take ACE-Is worldwide. C1-INH is a serine protease inhibitor that is normally found in the blood. Its primary function is the regulation of the complement and contact system pathways by binding irreversibly to target proteases. It additionally inhibits the fibrinolytic, clotting, and kinin pathways.31 Patients with the hereditary forms of AE (HAE) tend to have lower quantitative or functional levels of C1-INH. This results in decreased suppression of plasma kallikrein and factor XIIa leading to cleavage of high molecular weight kininogen to form increased circulating levels of bradykinin. Bradykinin binds to bradykinin 2 receptors resulting in separation of endothelial vascular cells and extravasation of fluid manifesting clinically as angioedema. Conestat alfa (Ruconest®) is a recombinant human C1-INH that has been purified from the breast milk of genetically modified rabbits. It is a single-chain soluble glycoprotein that is made of 478 amino acids. Administering conestat alfa increases the amount of C1-INH in these patients, repleting their levels, and acting as a treatment for AE due to C1-INH deficiency. Conestat alfa has been studied on asymptomatic patients with HAE and was shown to dose-dependently increase the level of functional C1-INH. Additionally, it was shown to restore the level of the complement C4 protein, which is also decreased in these patients. Since the same pathophysiological pathway is involved in patients with ACE-I-induced AE, it is reasonable to hypothesize its effectiveness in the treatment of patients with acute attacks.

Start Date01 Dec 2024

Sponsor / Collaborator

University of Maryland

NCT05145283

/ RecruitingPhase 2IIT

Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation: a Multi-center, Randomized, Double-blind, Placebo-controlled Investigational Study (PAIR-TAVI).

The aim of this trial is to assess the safety and efficacy of conestat alfa (Ruconest®, Pharming Technologies B.V.) on renal and cerebral ischemic events in patients undergoing TAVI for severe symptomatic aortic stenosis (AS) compared to placebo.

Start Date16 Mar 2022

Sponsor / Collaborator

Universitätsspital Basel

[+2]

NCT04912141

/ TerminatedPhase 2

Conestat Alfa (a Recombinant Human C1 Esterase Inhibitor) for the Prevention of Acute Kidney Injury After Non-ST Elevation Myocardial Infarction: a Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2, Dose-finding Study

A randomized, double-blind, placebo-controlled, multi-center, phase 2 clinical study in patients with NSTEMI undergoing urgent coronary angiography. Approximately 220 patients with CKD and acute NSTEMI, who are scheduled for an urgent coronary angiography (within 72 hours after admission and/or diagnosis of NSTEMI).

Start Date21 Apr 2021

Sponsor / Collaborator

Pharming Technologies BV

100 Clinical Results associated with Conestat alfa

100 Translational Medicine associated with Conestat alfa

100 Patents (Medical) associated with Conestat alfa

388

Literatures (Medical) associated with Conestat alfa

01 Nov 2025·World Allergy Organization Journal

Hereditary angioedema: A national investigation of associated comorbidities and surgical procedures

Article

Author: Szilágyi, Tamás ; Voloncs-Mindszenthy, Lili ; Andrási, Noémi ; Farkas, Henriette ; Horváth, Hanga Réka

Background:

Hereditary angioedema due to C1 inhibitor deficiency (HAE-C1INH) is characterized by sudden subcutaneous and/or submucosal angioedema attacks. C1 inhibitor is a serine protease inhibitor that regulates several enzyme cascade systems. The absence of this control raises concerns about the potential development of comorbidities.

Objective:

We aimed to investigate the comorbidities present in the Hungarian HAE-C1INH patient population and to examine the surgical procedures performed on these patients. Additionally, we sought to compare our results to those of the Hungarian general population.

Methods:

Demographical, clinical, laboratory, and radiographic data of all 178 adult HAE-C1INH patients followed up at the Hungarian Angioedema Center of Reference and Excellence were used to examine comorbidities and surgical procedures. Information about the general Hungarian population was extracted from national and European statistical databases and individual articles.

Results:

At least 1 comorbidity was present in 159 of our patients. From the observed 51 diseases, headache (58%), hypercholesterolemia (52%), hypertension (30%), and liver diseases (26%) were the most prevalent. Hypercholesterolemia and depression/anxiety were at least 3 times more common in the HAE-C1INH population as compared to the Hungarian general population. Tonsillectomy was performed 32, appendectomy 11, and inguinal hernioplasty 2 times more often before the diagnosis of HAE-C1INH was established. Every surgical procedure was more prevalent in the HAE-C1INH population.

Conclusion:

Regular, targeted screening is indispensable for the prevention and timely diagnosis of certain diseases found in higher prevalence in the HAE-C1INH population. The early identification and adequate treatment of angioedema attacks help prevent avoidable surgical interventions.

01 Nov 2025·World Allergy Organization Journal

C1 esterase inhibitor (C1–INH) response as a supportive diagnostic criterion for patients with suspected hereditary angioedema with normal C1–INH

Article

Author: Patel, Maunish ; Fatteh, Shahnaz ; Rivera, Ralph ; Jones, Douglas H ; Lim, Lily M ; Rumbyrt, Jeffrey ; Smith, Andrew M ; Chu, Teresa ; Memmott, Heidi ; Kanarek, Henry J ; Kashkin, Jay M ; Hussain, Yusaf

Diagnosis of hereditary angioedema (HAE) with normal C1INH level (HAE-nl-C1INH) is based on several criteria, including either an associated genetic variant identified or family history of recurrent angioedema plus lack of high-dose antihistamine response. A rapid, durable response to bradykinin-targeted medication is considered supportive, and this study aimed to evaluate the use of recombinant human C1 esterase inhibitor (rhC1-INH) in this regard. A retrospective medical records review was conducted for angioedema/HAE codes. Thirty-one patients with HAE-nl-C1INH were identified (female, 87.1%; mean age, 46.2 years; range, 16-74 years). All patients had experienced recurrent angioedema, with documentation of antihistamine and/or mast cell-targeted therapy ineffectiveness and normal/near-normal laboratory data. Genetic testing (n = 9) found no known pathogenic variants of HAE. Diagnosis of HAE-nl-C1INH was confirmed in the 31 patients via a favorable response after intravenous rhC1-INH (weight-based; maximum, 4200 U) during an angioedema attack. Only 30.0% (9/30) of patients with documented information had been aware of a family history of recurrent angioedema/HAE. In conclusion, reliance on a family history of recurrent angioedema as a diagnostic criterion may delay accurate diagnosis and access to effective treatment. These results support that responsiveness to C1-INH replacement therapy may also be a useful supportive diagnostic criterion for HAE-nl-C1INH.

01 Mar 2025·JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Clinical response and corresponding blood transcriptome pathways before and after treatment of hereditary angioedema prodromes compared to active swelling attacks

Article

Author: Bernstein, Cheryl K ; Bernstein, Jonathan A ; Singh, Umesh ; Anderson, John ; Ghosh, Debajyoti

BACKGROUND:

Approximately 85% of hereditary angioedema (HAE) attacks are associated with prodromal symptoms.

OBJECTIVE:

We investigated the clinical effect of treating HAE C1-esterase inhibitor (HAE-C1-INH) type 1 patients with recombinant human C1-INH (rhC1-INH) during their prodrome versus an active swelling episode and associated changes in blood transcriptomic genes and pathways before and after treatment.

METHODS:

A 2-center, unblinded, case-crossover study randomly assigned 5 HAE-C1-INH type 1 patients to prodrome or attack treatment groups; after a patient was treated for either 2 prodromes or 2 HAE attacks, they were crossed over to be treated for 2 HAE attacks or 2 prodromes. All patients were treated during the prodrome or acute attack with rhC1-INH; (conestat alfa, 50 IU/kg body weight, maximum 4200 IU for body weight ≥85 kg). Blood samples for analysis by RNA sequencing were obtained (1) at baseline, (2) during the prodrome before and after treatment, and (3) during an attack before and after treatment. Differentially expressed genes and pathways were elucidated by Ingenuity Pathway Analysis (IPA; Qiagen).

RESULTS:

Treatment during the HAE prodrome with rhC1-INH was as effective at preventing progression to a swelling episode as treatment of an acute attack. HAE prodromes were associated with upregulation of multiple inflammatory extracellular matrix genes, neuropeptide, and inflammasome member genes (eg, SPARCL1, AGRP, NLRP9; log₂ fold change = 4.1, 3.9, and 3.0, respectively). TNF-α and IL-10 were 2 major hub genes in prodrome-associated enriched gene networks. rhC1-INH treatment resulted in reversal of the disease signature in HAE-associated dysregulated pathways. Approximately 42% of prodrome-associated differentially expressed genes were also associated with HAE attacks. The enriched gene networks with hub genes for prodrome (ERK and VEGF) and for acute attack (insulin and SERPINA1) stages of HAE were identified. The major enriched pathways shared between HAE prodrome and attack were associated with neutrophil function and prostaglandin metabolism.

CONCLUSION:

Treatment of HAE-C1-INH type 1 patients who have a well-defined prodrome that historically results in an acute attack may be justified clinically and mechanistically. This approach would represent a paradigm shift for management of HAE on-demand treatment.

News (Medical) associated with Conestat alfa

02 Feb 2026

·www.fiercepharma.com

With FDA rejections, Aquestive's shares go up, while Pharming's go down

The FDA issued complete response letters to Aquestive Therapeutics and Pharming in recent days, resulting in vastly different reactions from the market. While Aquestive's share price increased, Pharming's dropped. The FDA issued complete response letters (CRLs) to two companies in recent days, resulting in vastly different reactions from the market.The U.S. regulator rejected Pharming’s bid to gain an expansion for Joenja to treat patients ages 4 to 11 with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare immunodeficiency. With the thumbs down, Pharming’s share price tumbled by 16% on Monday.Meanwhile, the FDA also swatted away Aquestive Therapeutics’ new drug application for Anaphylm sublingual film for the treatment of Type 1 allergic reactions, including anaphylaxis, in patients weighing at least 30 kg (66 pounds). But with the red light, Aquestive’s share price increased by 35%.The reason for the optimism on Anaphylm? The FDA’s concerns with the rescue treatment were limited to its packaging, administration and labeling guidance.“While it is unfortunate to have received a CRL, we believe that, with the clarity we now have from the FDA, we have made significant progress toward approval,” Dan Barber, the CEO of Aquestive, said in a release.The regulator cited difficulties in opening Anaphylm’s pouch and the potential for incorrect film placement, which “the FDA believes could cause significant safety issues in the setting of anaphylaxis,” Aquestive said in a release.“This opening is the one we use with multiple other products that are on the market and one product that’s been on the market for 15 years,” Barber said during a conference call on Monday morning. “It’s a bit of a head scratcher, but we’ll do the work that the FDA has requested.” Aquestive said it has already modified the pouch opening, its instructions for the drug's use and the labeling on its carton. The company will also conduct a new human factors validation study and plans to address potential tolerability issues with its resubmission, which could happen as early as the third quarter, it added.As a needle-free, oral epinephrine option, Anaphylm has been pegged as a potential blockbuster and a game-changer for the New Jersey-based company, which projected in November that its 2025 revenue would come in at between $44 million and $50 million.The CRL does not affect submissions for approval of the treatment in Europe and Canada, which are still on track by the end of this year, Aquestive said. Pharming rejectionIn the CRL the FDA sent to Pharming, the agency cited the potential for “underexposure” in lower-weight patients and has requested additional pediatric pharmacokinetic (PK) data, the company said. The FDA wants to reassess the proposed pediatric doses and confirm that children in the lower-weight dose groups can achieve exposure levels comparable to the approved regimen. The letter also identified an issue with one of the analytical methods used for production batch testing.“While we are disappointed in the FDA’s response, we remain dedicated to making Joenja available to pediatric patients aged 4-11 with APDS,” Fabrice Chouraqui, the CEO of the Netherlands-based company, said in a release. “We are going to work closely with the FDA to provide the necessary information and determine the best and most effective path forward.”The company said it believes it can address the PK and batch testing methodology issues and will request a Type A meeting with the FDA. Analysts from Jefferies noted that “importantly,” the CRL did not reflect any efficacy concerns, indicating that the drug will likely eventually gain approval for the age group. Jefferies added that a third-quarter approval would be a “best-case” scenario at this stage.More information could be available during the company’s investor presentation on Tuesday. Last month, Pharming reported (PDF) preliminary 2025 revenues of $376 million, up 27% from 2024. Through three quarters, Joenja—which was approved in 2023—had produced sales of $38 million, with $15 million coming in the third quarter.The big seller for Pharming is Ruconest, which generated sales of $231 million through the first nine months of 2025. The treatment was approved in 2014 for hereditary angioedema.

Drug Approval

02 Feb 2026

·endpoints.news

Pharming’s immunodeficiency drug gets CRL for use in younger patients

The FDA has issued a complete response letter to Pharming, rejecting its attempt to expand the approval of its drug for a rare form of immunodeficiency into younger patients. Joenja was approved in 2023 for a disorder called activated phosphoinositide 3-kinase delta syndrome (APDS) in patients aged 12 and up. On Sunday, the company said the regulator declined to approve the pill’s use in patients aged 4 to 11. Pharming’s Amsterdam-listed shares fell 15% in early trading on Monday. Growing Joenja’s sales is important for Pharming. Analysts expect revenues from its only other product, the hereditary angioedema therapy Ruconest, to fall starting this year, as some patients switch to KalVista’s Ekterly . According to Pharming, the FDA asked for more pediatric pharmacokinetic data due to concerns that lighter patients could be underexposed to the drug. The regulator wants to confirm that children in the lower-weight dose groups can be exposed to similar levels of Joenja as adult and adolescent patients. The approved dose for older patients is two 70 mg pills a day. Patients must weigh at least 45 kg to get the drug. The CRL also identified a problem with one of the methods used to test batches of the drug, and again the FDA requested additional data and clarification on this point. Pharming said it could address the issues raised in the letter and would seek a meeting with the FDA to discuss resubmission. Jefferies analysts wrote in a Monday note that they expect Joenja to be approved in the wider population “eventually,” as the letter did not take issue with the drug’s efficacy. They believe that expanded approval in the third quarter of 2026 could be the best-case scenario, with approval later in the year also a possibility, “assuming it will not take more than a couple of months to generate the required data.” APDS is caused by mutations in one of two genes, known as PIK3CD or PIK3R1, which regulate the maturation of white blood cells, particularly B cells and T cells. These cause hyperactivity of PI3 kinase delta, leading to proliferation of immature B and T cells, which can’t fight infections. Joenja is a small molecule that blocks the production of PI3 kinase delta, allowing immune cells to mature properly. The disorder is ultra-rare, affecting only one or two people in every million. In the US, Joenja costs around $50,000 for a month’s supply. The drug could gain approval in Europe and Japan this year. Phase 2 trials assessing it in patients with other primary immunodeficiencies due to immune dysregulation are also expected to report this year.

Drug ApprovalImmunotherapyPhase 2Accelerated Approval

08 Jan 2026

·www.pharming.com

Pharming Group reports preliminary 2025 revenues and announces Investor Day

Total 2025 revenues are estimated to be approximately US$376 million*, exceeding the upwardly revised guidance range of US$365 to US$375 million provided in November 2025 and representing approximately 27% growth versus 2024. This strong performance reflects continued growth of RUCONEST® and rising demand for Joenja®, driven primarily by patient uptake in the U.S. and supported by ongoing geographic expansion. Full-year 2025 operating expenses are expected to be within the previously communicated range of US$304 to US$308 million, underscoring our commitment to cost discipline. Looking ahead, we anticipate sustained revenue growth and continued advancement of our clinical pipeline in 2026. We plan to report complete fourth quarter and full year 2025 financial results on March 12, 2026. The Investor Day agenda will include a comprehensive update on our advancing pipeline, including leniolisib in Phase II proof of concept clinical trials for primary immunodeficiencies (PIDs) with immune dysregulation, including Common Variable Immunodeficiency (CVID) with immune dysregulation, as well as KL1333 in a pivotal clinical study (FALCON) for mitochondrial DNA (mtDNA)-driven mitochondrial disease. We will also present our 2026 financial guidance, highlighting anticipated revenue drivers and operating expense expectations. The program will feature presentations from leading clinical experts: Jocelyn Farmer, MD, PhD, Lahey Hospital & Medical Center — an internationally recognized authority on immune dysregulation and CVID Amel Karaa, MD, Massachusetts General Hospital, Harvard Medical School — an internationally recognized authority on mitochondrial medicine These key opinion leaders will discuss the evolving understanding of immune dysregulation in PIDs and the unmet need in mtDNA‑related mitochondrial disease, providing important clinical context for our development programs. Fabrice Chouraqui, Chief Executive Officer of Pharming, commented: “We delivered a strong year in 2025, driven by robust demand for our commercial assets and renewed financial discipline. RUCONEST® continued to grow in an increasingly competitive environment, while Joenja® uptake accelerated with rising U.S. patient demand and international expansion. As we enter 2026, we remain focused on advancing our clinical programs for additional PIDs with immune dysregulation and primary mitochondrial disease, while supporting continued growth of our commercial portfolio to drive long-term value creation. We look forward to providing a deeper update on these initiatives and sharing our 2026 financial outlook at our upcoming Investor Day.” Additional details for the Investor Day, including registration information, will be made available on our website in the coming weeks. * Preliminary, unaudited revenues. Final results may differ from the estimates provided in this release and will be reported in the Company’s financial results for the fourth quarter and full year 2025, to be published in March 2026.

Phase 2Financial StatementImmunotherapy

100 Deals associated with Conestat alfa

External Link

KEGG	Wiki	ATC	Drug Bank
D10845	Conestat alfa	B06AC04	DB09228

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hereditary Angioedema	European Union	Pharming Group NV	28 Oct 2010
Hereditary Angioedema	Iceland	Pharming Group NV	28 Oct 2010
Hereditary Angioedema	Liechtenstein	Pharming Group NV	28 Oct 2010
Hereditary Angioedema	Norway	Pharming Group NV	28 Oct 2010

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute Ischemic Stroke	Phase 2	Switzerland	Pharming Technologies BV	16 Mar 2022
Angina, Unstable	Phase 2	Switzerland	Pharming Technologies BV	21 Apr 2021
Non-St Elevated Myocardial Infarction	Phase 2	Switzerland	Pharming Technologies BV	21 Apr 2021
COVID-19	Phase 2	Brazil	Pharming Technologies BV	06 Aug 2020
COVID-19	Phase 2	Mexico	Pharming Technologies BV	06 Aug 2020
COVID-19	Phase 2	Switzerland	Pharming Technologies BV	06 Aug 2020
Acute Kidney Injury	Phase 2	Switzerland	Pharming Technologies BV	01 Jan 2017
Antibody-mediated rejection	Phase 2	United States	Pharming Technologies BV	01 Dec 2010
Graft Rejection	Phase 2	United States	Pharming Technologies BV	01 Dec 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01359969 (CTgov)	Phase 2	Hereditary Angioedema	57	rhC1INH	hfhqjymcoj(wxfkmrzmpb) = btngxaiwxa cdeexxpaaw (zlrbkwfftu, mukaycopav - jbpgjcqcmw) View more	-	29 Mar 2024
NCT04530136 (CTgov)	Phase 2	COVID-19	38	Ruconest (Ruconest)	nxzmnzebsp = hqdnomgiwt wggpwdctbc (rzswmamglb, rleqmsuagd - jbmmejudut) View more	-	16 Feb 2024
				Ruconest (Standard of Care)	nxzmnzebsp = znsenecmfg wggpwdctbc (rzswmamglb, cmpoeqwzuk - nkqwlbswbf) View more
NCT02869347 (PROTECT, ERA2019)	Phase 2	Kidney Diseases urinary neutrophil gelatinase-associated lipocalin (NGAL) \| serum C1 inhibitor levels \| cystatin C	77	Conestat alfa	wkcumkfnhl(dmxtwgmven) = qqdnunerqc zugvhknusv (zvdrcalatl ) View more	Positive	13 Jun 2019
				Placebo	wkcumkfnhl(dmxtwgmven) = cinlutajfk zugvhknusv (zvdrcalatl ) View more
NCT02247739 (CTgov)	Phase 2	Hereditary Angioedema	32	Recombinant human C1 inhibitor (rhC1INH Twice Weekly)	oivhvqcuec(ngsnatevra) = uulvfhxjeb gdojjtxjdc (rqdehyinol, mdkokvpwxa - stwkdnqomg) View more	-	08 Dec 2017
				Recombinant human C1 inhibitor (rhC1INH Once Weekly)	oivhvqcuec(ngsnatevra) = kvumlhzyiu gdojjtxjdc (rqdehyinol, sxvzedszqt - yjgdxvpfee) View more
NCT01188564 (CTgov)	Phase 3	Hereditary Angioedema	75	rhC1INH (rhC1INH)	qpqozopjsd(hidmrzszdy) = umvswwxiit chxxonmkia (yugwwqqaxr, rhpingruzv - nckajmmtyc) View more	-	07 Aug 2015
				Placebo (Saline) (Placebo (Saline))	qpqozopjsd(hidmrzszdy) = xpqutcttrk chxxonmkia (yugwwqqaxr, qglcckarjb - wzkszkaplu) View more
NCT01188564 (Pubmed \| Ann Allergy Asthma Immunol) Manual	Phase 3	Hereditary Angioedema	75	rhC1INH	hmjhkupohf(vlkhtzwmgp) = drzbngxras vbtyyicpxn (xjzdybdsuz, 61 - 150) View more	Positive	01 Feb 2014
				Placebo	hmjhkupohf(vlkhtzwmgp) = blgnprfqra vbtyyicpxn (xjzdybdsuz, 93 - NE) View more
NCT00851409 (OPERA, CTgov)	Phase 2	Hereditary Angioedema	25	Recombinant Human C1 Inhibitor	cnlbzdtmsg(zfbebwvmdb) = ltvylujgor xuhuasmkya (fpuxaxfpnn, xhpunpqrsc - uslkbwmxhx) View more	-	31 Jan 2013
NCT00262301 (CTgov)	Phase 3	Hereditary Angioedema	75	recombinant human C1 inhibitor (100 IU/kg "rhC1INH")	ulqvzuusoe(iirpnwyhis) = eqhlvicrkx zhxdbdbxwi (ewfwundrwx, zbiqbtkrfv - wtuwlonare) View more	-	30 Aug 2012
				Placebo (Saline)	ulqvzuusoe(iirpnwyhis) = wmzuvohlfa zhxdbdbxwi (ewfwundrwx, xafxgouzrk - szylppsemo) View more

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