Delving into the Latest Updates on Lanadelumab with Synapse

RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (Australia), Priority Review (United States)

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Structure/Sequence

Sequence Code 9684251H

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Sequence Code 9684277L

Source: *****

Bradykinin is a potent vasodilator that is formed by the activation of the kallikrein-kinin system. We and others have shown that bradykinin increased during hemodialysis; however, the role of bradykinin in dialysis-induced hypotension (DIH) has not been evaluated. Preliminary results from a pilot clinical trial showed that bradykinin B2 receptor blockade with icatibant prevents excessive blood pressure during hemodialysis. Thus, in this study, we will test the overarching hypothesis that blockade plasma kallikrein with lanadelumab would ameliorate the reduction of blood pressure during hemodialysis in patients who are prone to DIH. For this purpose, we will conduct a parallel arm, double-blind placebo-controlled trial, using lanadelumab to evaluate the occurrence of

Start Date27 Jul 2022

Sponsor / Collaborator

Vanderbilt University Medical Center

100 Clinical Results associated with Lanadelumab

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100 Translational Medicine associated with Lanadelumab

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100 Patents (Medical) associated with Lanadelumab

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165

Literatures (Medical) associated with Lanadelumab

01 Jun 2026·BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Intravenous lanadelumab for the treatment of moderately ill COVID‐19 patients

Article

Author: Roger Brüggemann ; W. Joost Wiersinga ; Job J. Engel ; Christine van Linge ; Roger Schutgens ; Danique J. H. Huijbens ; Kit C. B. Roes ; Helen L. Leavis ; Coen Maas ; Robert-Jan Hassing ; Quirijn de Mast ; Ilse J. E. Kouijzer ; Frank L. van de Veerdonk

Aims:

Kallikrein‐kinin system (KKS) dysregulation is hypothesized to play a pathogenetic role in COVID‐19‐associated pulmonary oedema. To investigate the efficacy and safety of intravenous lanadelumab, a monoclonal antibody that inhibits plasma kallikrein, in COVID‐19, we conducted a phase 2, open‐label, randomized‐controlled, proof‐of‐concept, interventional trial.

Methods:

We recruited 40 patients hospitalized with moderate COVID‐19 and randomized them 1:1 to receive either standard‐of‐care (SoC) treatment or SoC plus intravenous lanadelumab (300 mg on days one and four). The primary outcome consisted of repeated measurements of supplemental oxygen (litres/minute) necessary to maintain a peripheral oxygen saturation (SpO 2 ) ≥ 93%. Secondary outcomes included modified WHO‐CPS scores, need for high‐flow oxygen therapy or mechanical ventilation, admission to the intensive care unit, length of hospital stay and all‐cause mortality over a 14‐day period.

Results:

Sufficient endpoint data for the population were available for the first five days, but not for the previsioned 14‐day endpoint. Consequently, analysis of the primary endpoint was based on the first five days of treatment. Within this timeframe, lanadelumab did not significantly affect supplemental oxygen volumes. Neither treatment nor interaction between treatment and time was a significant predictor of oxygen volumes in a linear mixed model (p = 0.49 and p = 0.15, respectively). None of the secondary outcomes was significantly affected by lanadelumab. Intravenous lanadelumab was well tolerated.

Conclusions:

This exploratory study was evaluated using a shortened primary endpoint period. Lanadelumab showed no indication of benefit on oxygen needs or other clinical outcomes in patients with COVID‐19. Lanadelumab was well tolerated throughout the trial.

04 May 2026·EXPERT OPINION ON BIOLOGICAL THERAPY

Monoclonal antibodies in the management of hereditary angioedema

Review

Author: Farkas, Henriette ; Voloncs-Mindszenthy, Lili ; Horváth, Hanga Réka

INTRODUCTION:

Hereditary angioedema (HAE) is a rare, potentially life-threatening, unpredictable disease characterized by recurrent subcutaneous and/or submucosal edema (HAE attacks). HAE imposes a significant biopsychosocial burden on patients and their families owing to the erratic nature and variable severity of HAE attacks. Current guidelines appoint sustained disease control as one of the main treatment goals, achievable through the initiation of long-term prophylaxis (LTP).

AREAS COVERED:

This review focuses on the evaluation of three monoclonal antibodies developed for LTP of HAE, namely lanadelumab (Takhzyro®), garadacimab (Andembry®), and navenibart, in this order. Lanadelumab inhibits plasma kallikrein and has been an approved LTP option since 2018. Garadacimab inhibits activated factor XII (FXIIa) and has been approved for LTP in 2025. Navenibart, a drug currently under development, inhibits plasma kallikrein and has been modified to extend its circulating half-life.

EXPERT OPINION:

The transition from older non-targeted LTP options to the use of monoclonal antibody-based therapies has fundamentally changed the treatment landscape by offering a safe, effective, and highly targeted solution. Although having different pharmacological characteristics, these LTP options share the same objective: to achieve complete disease control.

01 Mar 2026·DRUGS IN R&D

Treatment Outcomes with Lanadelumab Every 2 Weeks and Garadacimab are Very Similar in Patients with Hereditary Angioedema

Letter

Author: Khutoryansky, Natalie ; Dangel, Alissa ; Andresen, Irmgard ; Feeny, Sarah L

98

News (Medical) associated with Lanadelumab

13 May 2026

·www.fiercepharma.com

Takeda, slimming down for 'new era,' plots 4,500 layoffs in latest restructuring drive

The Japanese pharma is targeting 2026 revenues of 4.64 trillion Japanese yen ($29.4 billion). With a new CEO prepared to take the reins next month and three key launches on deck for 2026 and 2027, Takeda is ready to shake off the generic-related declines that have plagued revenues in recent years as it eyes a “new era” to be marked by growth acceleration, according to the Japanese pharma.However, several thousand employees won’t be entering the new chapter with the company. In its full-year earnings presentation (PDF) on May 13, Takeda filled in details on its 2026 “transformation program,” which looks to centralize corporate functions, reduce management layers and target process simplification. The multiyear slim-down is expected to hit about 4,500 roles during the 2026 fiscal year, resulting in about 170 billion Japanese yen ($1.07 billion) in restructuring costs and some 100 billion yen ($633 million) in gross savings for 2026, the company said. More than 200 billion yen ($1.26 billion) in annualized savings is projected by 2028. Takeda recently telegraphed a round of job reductions in the U.S, affecting 634 roles assigned to the company’s U.S. headquarters in Cambridge, Massachusetts, as part of the $1.26 billion efficiency drive. The latest restructuring comes on the heels of 2024-2025’s “enterprise-wide efficiency program,” which saw over 4,000 positions impacted over the two years, Takeda noted. Takeda’s cost-savings push began in 2024, as revenues for its blockbuster attention-deficit/hyperactivity disorder med Vyvanse rapidly declined in the face of generics swarming the market upon its patent expiration, a struggle that has haunted the organization since. With the company predicting last year that 2025 would be the last year of major generic headwinds to Vyvanse, Takeda is hoping that its three upcoming new launches will help put its Vyvanse-related sales woes in the rearview. In fiscal 2026, which ends in March 2027, the company anticipates full-year revenues of 4.64 trillion Japanese yen ($29.4 billion), reflecting “mature portfolio headwinds in a year that we pivot to new launches,” it explained in its presentation. The new launches include potential regulatory approvals for Takeda’s three leading late-stage assets in narcolepsy treatment oveporexton, polycythemia vera candidate rusfertide and psoriasis medicine zasocitinib. Oveporexton and rusfertide are both under priority review with the FDA and could see a U.S. commercial launch during the second half of 2026, while the company is making “decisive investments” to support a zasocitnib regulatory filing later this year. “We are very, very excited about these three launches, and we’re laser-focused on the execution,” CEO-Elect Julie Kim said on the company’s earnings conference call with investors. As the company zeroes in on transitioning to a “new cohort of blockbuster brands” that positions it for “long-term profitable growth and patient impact,” Kim said in a release, Takeda is outlining its metamorphosis in two phases. The first step, dubbed “Horizon One,” will see the company establish a trio of new growth drivers while ensuring the “resilience and competitiveness” of its core in-line brands. After that, “Horizon Two” will launch another wave of late-stage pipeline assets and maximize revenue from the first launches.Takeda enters its 2026 fiscal year with 684.5 billion yen ($4.3 billion) in free cash flow after collecting full-year 2025 revenues of 4.5 trillion yen ($28.3 billion) in a 1.7% year-over-year decline. Over half (51%) of the company’s yearly revenue came from its collection of growth and launch products, which includes blockbuster inflammatory bowel disease (IBD) drug Entyvio and hereditary angioedema (HAE) drug Takhzyro, among others. Put together, the selection of growth products spread across the company’s six key business areas together earned 2.3 trillion Japanese yen ($14.5 billion) over the year, which “partially mitigated” the continued impacts of Vyvanse’s generic erosion. Vyvanse and other products impacted by patent expirations saw a pooled sales decline of 43% over the year, the company noted in its presentation. Takeda’s full-year 2025 earnings conference call was the last under longtime CEO Christophe Weber, who took over the pharma in 2015 after a 20-year career at GSK. Weber was the first non-Japanese CEO in the company’s over 200-year history and was credited with “building Takeda into the company it is today,” Kim said on the call. Kim, who joined Takeda in 2019, had headed up the company’s U.S. operations since 2022 and was selected as CEO as part of a “thoughtful and intentional” succession process, Weber noted.

Executive ChangePriority Review

27 Apr 2026

·www.fiercebiotech.com

Intellia races in vivo CRISPR therapy to FDA after phase 3 data paint ‘compelling’ picture

Shares in Intellia rose 4% to $14.20 in premarket trading. \n A phase 3 trial of Intellia Therapeutics’ in vivo gene-editing therapy lonvoguran ziclumeran (lonvo-z) has hit its primary endpoint, leading the biotech to start a rolling submission for FDA approval. The study randomized 80 people with hereditary angioedema (HAE) to receive lonvo-z or placebo. HAE is a rare genetic condition characterized by recurrent and potentially life-threatening swelling. Noting that overproduction of bradykinin drives the disease, Intellia bet it could improve outcomes by using CRISPR to inactivate a gene needed to produce the peptide. Intellia’s phase 3 Haelo data validate the hypothesis, while leaving the question of whether the bet will pay off commercially unanswered. One infusion of lonvo-z reduced swelling attacks by 87% compared to placebo during the six-month efficacy evaluation period, hitting the trial’s primary endpoint.The investor bull case was for about a 90% placebo-normalized reduction in attack rates, William Blair analysts said in a note to investors Monday. However, hitting that target depended on a very low placebo response, which the analysts said: “can be tricky to navigate for more mild attacks.” Intellia beat William Blair’s 80% base case, leading the analysts to call lonvo-z a “compelling one-time option.” The trial met all key secondary endpoints. Intellia said 62% of patients were attack- and therapy-free in the lonvo-z arm during the six-month efficacy evaluation period, compared with 11% of patients in the placebo cohort.The data suggest lonvo-z is at least as effective as existing treatments for HAE. Ionis Pharmaceuticals won FDA approval for Dawnzera last year after linking the antisense oligonucleotide to an 81% reduction in attacks versus placebo. Other treatments include Takeda’s blockbuster standard of care, Takhzyro, and BioCryst Pharmaceuticals’ Orladeyo.While the existing HAE arsenal contains a mix of injectable and oral drugs, all of the treatments require people to keep taking medicines to prevent attacks. Lonvo-z could permanently reduce HAE attacks after a single dose. “Lonvo-z appears highly differentiated given its ability to free most patients from both attacks and ongoing treatment with just one dose,” Marc Riedl, M.D., clinical director of a HAE center at UC San Diego, said on Intellia’s call with analysts to discuss the phase 3 lonvo-z data. “The efficacy observed in Haelo appears highly competitive and attractive.” Intellia aims to complete its rolling submission in the second half of the year, putting it on track to launch the therapy in the first half of 2027. If the FDA approves lonvo-z, Intellia will face the challenge of reassuring patients that a treatment that permanently edits their DNA is safe and a better option than existing therapies.The most common treatment-emergent adverse events (TEAEs) during the phase 3 primary observation period were infusion-related reactions, headache and fatigue. All TEAEs were mild or moderate and no serious adverse events were observed in the lonvo-z arm.The safety of gene editing was thrust into the spotlight last year when a patient suffered liver injury and died from septic shock following rupture in the intestine after receiving Intellia’s nex-z. Lonvo-z was unaffected by the resulting clinical hold. Yet Guggenheim Securities analysts said in a note to investors at the time that the safety concerns mean lonvo-z may face commercial headwinds, especially as in their view the phase 3 trial was too small to allay the worries. Intellia CEO John Leonard, M.D., said on the Monday analyst call that one grade 2 case of elevated liver enzymes was observed. The event happened a couple of weeks after dosing, was asymptomatic and resolved spontaneously within one week. Other patients had grade 1 cases. Some companies have struggled to get patients to switch from ongoing treatments to one-time genetic medicines. BioMarin recently pulled its hemophilia gene therapy Roctavian from the market after failing to capture a significant share of a market served by drugs such as Roche’s bispecific antibody Hemlibra. Even those closest to HAE patients are unsure how widely lonvo-z will be adopted. Burden of treatment is a real thing for HAE patients, Riedl said. Yet while the doctor expects patients burdened by existing drugs to “look long and hard” at lonvo-z, he said he lacks “a good sense” of what percentage will elect to have the treatment.Shares in Intellia rose 4% to $14.20 in premarket trading.

Phase 3Clinical ResultGene TherapyOligonucleotideDrug Approval

15 Apr 2026

·www.fiercepharma.com

Ionis exec shares method to the Madness after 2026 Drug Name Tournament win

This was Ionis' second FierceMadness win. Drug names are complicated things. For one, they must linguistically fulfill the role of being a shiny bauble for prescribers to be memorable enough to outshine competitors.But they must also walk a fine regulatory line so as not to become a marketing puff (no “CurezAll” here), while still standing apart from the thousands upon thousands of other branded drug names that already exist. “Naming drugs is getting harder and the list [of potential drug names] gets shorter as time goes on,” Kyle Jenne, Ionis’ EVP and chief global product strategy officer, said in an interview with Fierce Pharma Marketing. “There’s a lot of research that goes into it and a lot of complexity.” But whilst a challenge, it’s still a creative and fun process, Jenne said. He should know, having helped work on Ionis’ Dawnzera (donidalorsen), this year’s FierceMadness Drug Name Tournament winner. “When we do these names, we want to make sure that they are distinctive,” he explained. “We also try and refer where we can to the disease state and the area of medicine that we’re working in. But it also needs to be simple and easy to recognize—a lot of these names are starting to get pretty complex. It’s good to be able to hear a name and then actually relate to it.”It’s important to Jenne and Ionis that not just doctors but also patients are front and center when considering drug names. “We want to make sure that [consideration of the patient] comes through in the branding, as well as for the physicians prescribing it.” All these elements came together for Dawnzera, a drug approved in August last year by the FDA as a prophylaxis to prevent attacks of hereditary angioedema (HAE).Jenne said: “A ‘dawn’ of a new era; that element is clear from the name and when you think about the innovation of the product: the first RNA-targeted therapeutic available [in the HAE space]. Well, that’s genuinely a new offering, so we wanted that to come through.”Dawnzera is also built on the clinical name donidalorsen. With clinical names existing long before branding comes into play, it’s becoming more common for wordplay here to come into the drug’s final name. The “Dawn” in Dawnzera is also linked to the “don” in the ingredient name, Jenne explains. “Internally, we have been calling it ‘dawny’ in short for donidalorsen.” The drug, whilst a first in its class, was launched into a crowded general HAE market. Since 2008, the FDA has approved 11 treatments for the rare genetic condition, with three of the nods coming during the summer of ’25, including Ionis’ med. Those other approvals were Ekterly, from the small biotech KalVista Pharmaceuticals, as well as for CSL, which scored a June ‘25 FDA nod for Andembry.The two big drugs in this space include Takeda’s blockbuster standard-of-care Takhzyro and BioCryst Pharmaceuticals’ fast-rising oral challenger Orladeyo, underscoring the level of competition Dawnzera has when it comes to branding in this space.This was Ionis’ second Drug Name Tournament win, coming after its 2024 victory with drug partner AstraZeneca for Wainua. Next year, FierceMadness will be challenging drug ads against each other, but in 2028, Ionis will hope to return with a potential new drug name to defend its title.

Drug Approval

100 Deals associated with Lanadelumab

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External Link

KEGG	Wiki	ATC	Drug Bank
D11094	Lanadelumab	B06AC05	DB14597

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Hereditary Angioedema	United States	Takeda Pharmaceuticals U.S.A., Inc.	23 Aug 2018

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Angioedema	Phase 3	United States	Shire Plc	05 Feb 2021
Angioedema	Phase 3	Japan	Shire Plc	05 Feb 2021
Angioedema	Phase 3	Canada	Shire Plc	05 Feb 2021
Angioedema	Phase 3	France	Shire Plc	05 Feb 2021
Angioedema	Phase 3	Germany	Shire Plc	05 Feb 2021
Angioedema	Phase 3	Hungary	Shire Plc	05 Feb 2021
Angioedema	Phase 3	Italy	Shire Plc	05 Feb 2021
Angioedema	Phase 3	Netherlands	Shire Plc	05 Feb 2021
Angioedema	Phase 3	Poland	Shire Plc	05 Feb 2021
Angioedema	Phase 3	Spain	Shire Plc	05 Feb 2021

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Clinical Result

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAAAI2026	Not Applicable	Hereditary Angioedema	36	Lanadelumab	hddmkarwod(xriwmjkjsh) = qemomuziny kfeklobtub (ubothyigck ) View more	Positive	27 Feb 2026
NCT04130191 (ENABLE, AAAAI2026)	Not Applicable	Hereditary Angioedema	27	Lanadelumab	wwnrunxmqk(yxigbwcujn) = aqqbnsqtqk weuwcaajst (gkfmvivzpn, 0.2) View more	Positive	27 Feb 2026
AAAAI2026	Not Applicable	Hereditary Angioedema	499	Takhzyro	iarxmxyikw(yegoluejfo) = aqivqpeubv orguitzzyd (vtignnhsyd ) View more	Negative	27 Feb 2026
NCT05297786 (Hinder, CTgov)	Phase 2	Kidney Failure, Chronic \| Nephrosis \| Dialysis hypotension	28	Lanadelumab (Lanadelumab)	fhxswmkmus(xuwugryfxo) = oegpqwrqpa jdpondxvnc (ajeamngxaq, 36.3) View more	-	20 Jan 2026
NCT05297786 (Hinder, CTgov)	Phase 2	Kidney Failure, Chronic \| Nephrosis \| Dialysis hypotension	28	Placebo (Placebo)	fhxswmkmus(xuwugryfxo) = ehzutagdzl jdpondxvnc (ajeamngxaq, 28.8) View more	-	20 Jan 2026
NCT03845400 (EMPOWER, Pubmed \| Adv Ther)	Phase 4	Hereditary Angioedema C1 inhibitor deficiency type 1	109	Newly treated with Lanadelumab	cdqicysewd(dtsogyaonh) = oxgmxtkajo gupbidfklm (amliclwboj, 0.34 - 2.50)	Positive	01 Aug 2025
NCT03845400 (EMPOWER, Pubmed \| Adv Ther)	Phase 4	Hereditary Angioedema C1 inhibitor deficiency type 1	109	Established on Lanadelumab	cdqicysewd(dtsogyaonh) = ogsmnwpony gupbidfklm (amliclwboj, 0.10 - 0.30)	Positive	01 Aug 2025
NCT04444895 \| NCT04206605 (CASPIAN Study, Pubmed \| Front Immunol)	Phase 3	Hereditary Angioedema Type III	77	Lanadelumab 300 mg every 2 weeks	tfyuwgojkf(xroyansksh) = hejfzmnwyc qbmqgisbdk (yfpvxgwpyn )	-	21 May 2025
	Phase 3	Hereditary Angioedema Type III	77	Placebo	tfyuwgojkf(xroyansksh) = miswsblfsv qbmqgisbdk (yfpvxgwpyn )	-	21 May 2025
NCT04130191 \| NCT03845400 (Phase 4 studies (EMPOWER, ENABLE), Pubmed \| Pediatr Allergy Immunol)	Phase 4	Hereditary Angioedema	-	Lanadelumab 300 mg	hcfehwmxdh(jqjxcctoqq) = Nine new patients reported 42 TEAEs, mostly mild/moderate in severity, with 3 TEAEs reported as serious. Seven established patients reported 12 TEAEs (all mild/moderate and non‐serious). No TEAEs were related to lanadelumab. kvjzkznumo (jjjztceabo )	Positive	01 Apr 2025
NCT05460325 (CTgov)	Phase 3	Hereditary Angioedema	20	Lanadelumab	tewluycqyq = jaslbkozef kpshjqbczg (wkymajhbpk, xkfhazmcur - rpirmoyrgj) View more	-	13 Dec 2024
NCT02741596 (HELP Study and HELP OLE, Pubmed \| Ann Allergy Asthma Immunol)	Phase 3	Hereditary Angioedema	21	Lanadelumab 300 mg	isnxpbbhju(brbuleptfs) = 12 (57.1%) patients reported treatment-related treatment-emergent adverse events; however, there were no treatment-related serious adverse events. fxbnoljhqo (xnbpdlimoe ) View more	Positive	01 Dec 2024
NCT04444895 (CTgov)	Phase 3	Angioedema \| Hereditary Angioedema Type III	73	Lanadelumab	uzgivpiveh(tgehohmwlh) = gzmpvnybhj puwfmhrfse (pxscbfhdwx, gszwkcxmii - lwioxfqazu) View more	-	17 Jun 2024

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Lanadelumab

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