RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Conditional marketing approval (European Union)

Structure/Sequence

Sequence Code 14292967

Source: *****

Sequence Code 14449558

Source: *****

Clinical Trials associated with Andexanet alfa

NCT05926349

/ WithdrawnPhase 3

A Randomized Study of Andexanet Alfa Compared to Usual Care in Patients Receiving a Factor Xa Inhibitor Who Require Urgent Surgery or Procedure (ANNEXA-RS)

The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures. The study will compare the use of andexanet alfa to the usual care given at the study center.

Start Date02 Aug 2024

Sponsor / Collaborator

AstraZeneca PLC

NCT05898412

/ RecruitingNot Applicable

Retrospective Real World Evidence Study to Describe Characteristics and Outcomes in Dutch Patients Admitted to the Hospital With a Factor Xa Inhibitor-associated Bleeding Treated With Andexanet Alfa

This is an observational retrospective database study of hospitalized patients treated with andexanet alfa in approximately 10 Dutch hospitals. Currently there is limited information on the patient characteristics and outcomes of patients who are treated with andexanet alfa in The Netherlands and how it is used. This is of interest for treating clinicians because there is a need for a patient profile, also due to the on par position of andexanet alfa with PCC in the Dutch national guideline.
Analysis of the data showed that 14 patients of the 218 patients included in the study (6.4%) experienced a thrombotic event (TE) within 30 days after treatment with andexanet alfa. The protocol was amended to allow for an in depth analysis of the 14 TE cases.

Start Date06 Oct 2023

Sponsor / Collaborator

AstraZeneca PLC

NCT05548777

/ CompletedNot Applicable

Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed

This is an observational study based on data collected via an audit of electronic medical charts. The study population will include adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an anticoagulation-related major bleed, and their characteristics, treatments and outcomes will be described.

Start Date15 Sep 2022

Sponsor / Collaborator

AstraZeneca PLC

100 Clinical Results associated with Andexanet alfa

100 Translational Medicine associated with Andexanet alfa

100 Patents (Medical) associated with Andexanet alfa

432

Literatures (Medical) associated with Andexanet alfa

01 Dec 2025·JOURNAL OF CRITICAL CARE

Major publications in the critical care pharmacotherapy literature: 2024

Review

Author: Brown, Sophia ; Li, Ji ; Murray, Brian ; Farrar, Julie ; Roginski, Matthew A ; Bernardoni, Brittney ; Filiberto, Dina M ; Thompson, Tori R ; Perrodin, Jenna S ; Kopp, Brian J ; Esteves, Alyson M ; Madorsky, Melanie ; Tallon, Joanna K ; Moore, Megan J

OBJECTIVES:

To summarize, analyze, and provide clinical insights on the most impactful publications related to critical care pharmacotherapy in 2024.

METHODS:

A systematic search of PubMed/Medical Literature Analysis and Retrieval System Online (MEDLINE) was conducted between January 1, 2024, and December 31, 2024. Randomized controlled trials, prospective study designs, or retrospective study designs with high-quality methodology of adult critically ill patients assessing a pharmacotherapeutic intervention and reporting clinical endpoints were considered for inclusion. An a priori defined three-round modified Delphi process was performed to achieve consensus from a multi-disciplinary and geographically diverse group of critical care clinicians, focusing on the publications deemed most impactful based on their overall contribution to scientific knowledge and novelty.

RESULTS:

The systematic search yielded a total of 1533 articles, of which 1492 were excluded. Forty-one articles were included in the modified Delphi process. In each round, articles were independently scored based on their overall contribution to scientific knowledge and novelty and articles achieving a score at or above the median proceeded to the next round of voting. The six included articles are summarized and their impact is discussed. Article topics included cessation of proton pump inhibitors during transitions of care, stress ulcer prophylaxis in mechanically ventilated patients, continuous infusion beta-lactams in sepsis, ceftriaxone for prevention of ventilator-associated pneumonia, optimal antibiotic duration for bloodstream infections, and andexanet alfa for management of intracranial hemorrhage associated with factor Xa inhibitors.

CONCLUSIONS:

This review identified, summarized, and evaluated high impact studies relevant to critical care pharmacotherapy published in 2024.

01 Dec 2025·JOURNAL OF EMERGENCY MEDICINE

Latin America Multidisciplinary Consensus Panel on Management of Severe Bleeding in the Anticoagulated Patient

Article

Author: Noble-Lugo, Alejandra ; Meillon-Garcia, Luis Antonio ; Colunga-Lozano, Luis Enrique ; Guerra, Joao Carlos de Campos ; Rosales, Julieta S ; Ceresetto, Jose Manuel ; Arenas, Ana Cristina Montenegro ; Pontes-Neto, Octávio M ; Kreitzer, Natalie P ; Gibler, W Brian ; Rodrigues, Roseny Dos Reis ; Tellez, Luis Eduardo Vargas

BACKGROUND:

Bleeding is the most important complication associated with anticoagulants. Patients experiencing bleeding while on an anticoagulation require proper risk stratification, which involves careful assessment of multiple factors, including hemodynamic stability, the origin of bleeding, and the extent of blood loss. Over the last several decades, important advances have been made in the field of anticoagulant therapy and reversal.

OBJECTIVES:

This manuscript provides a review of anticoagulant related hemorrhages, with particular emphasis on topics most relevant to Latin America. It offers an updated assessment of evidence-based strategies for managing major bleeding related to anticoagulation. We will also explore what happens to patients in real-life situations, where there are not specific reversal agents available.

DISCUSSION:

While minor bleeding can usually be managed simply by discontinuing the anticoagulant, major bleeding is a medical emergency that may threaten life and require the administration of blood products and the utilization of specific antidotes. Fresh frozen plasma (FFP) or prothrombin complex concentrates (PCCs) can be administrated for major bleeding incidents linked to warfarin. Protamine sulfate is administrated for unfractionated heparin and partially for low-molecular-weight heparin (LMWH). Idarucizumab is the reversal agent for dabigatran, while andexanet alfa is approved for the reversal of oral factor Xa inhibitors.

CONCLUSIONS:

This review highlights the significance of appropriate risk stratification and management strategies for bleeding complications associated with anticoagulants. The manuscript emphasizes the need for adaptable management strategies in regions like Latin America, where resource limitations may impact the availability of specific reversal agents.

01 Nov 2025·Blood vessels, thrombosis & hemostasis

Procoagulant off-target effect of the direct oral anticoagulant reversal agent andexanet alfa

Article

Author: de Laat, Bas ; Middelveld, Harmen ; Schönichen, Claudia ; Zhao, Junxiong ; Heemskerk, Johan W M ; Heylen, René ; Sun, Siyu ; Stragier, Hendrik ; Roest, Mark ; Hoornstra, Ischa M S

Patients with hemorrhage after treatment with direct oral anticoagulants (DOACs) are saved from hematoma expansion by administration of Andexanet alfa, a modified factor Xa analog. A recent clinical trial points to incidental prothrombotic effects after Andexanet alfa treatment. We investigated mechanisms explaining the thrombogenic side effect. Calibrated automated thrombin generation was employed to assess the effect of Andexanet alfa on the coagulant potential of DOAC-treated plasma and whole blood. The study examined anticoagulant inhibition pathways involving tissue factor pathway inhibitor (TFPI), antithrombin, and endothelial cell components. Treatment of control plasmas with rivaroxaban, apixaban, or edoxaban resulted in an impaired thrombin generation, exemplified by a prolonged lag time and reduced thrombin peak height. Andexanet alfa over-converted this anticoagulant activity into a procoagulant effect. Plasma treatment with Andexanet alfa similarly increased thrombin generation in the absence of DOACs, even at 8 nM far below the therapeutic dose. The enhancement was abrogated in the absence or by blocking of TFPI. The Andexanet alfa effect was enhanced in the presence of heparin, thereby reversing the antithrombin protection. In the presence of endothelial cells, Andexanet alfa stimulated coagulation via TFPI and heparin inhibition. Andexanet alfa overconverts the anticoagulant effect of rivaroxaban, apixaban, and edoxaban to achieve a hypercoagulable plasma state. The action mechanism involves TFPI inhibition and neutralization of antithrombin-heparin complexes. This may account for the incidence of thrombosis observed in patients treated with Andexanet alfa.

News (Medical) associated with Andexanet alfa

31 Dec 2024

·www.echemi.com

7 New Drugs Expected to Be Approved in 2025

In 2024, China approved several new drugs, and more blockbuster drugs are expected to be launched in 2025, covering oncology, autoimmune diseases, rare diseases, and other therapeutic areas. Drug Name Mechanism of Action Indications Development Institutions Evantuzumab c-Met/EGFR bispecific antibody Non-small cell lung cancer Johnson & Johnson; Genmab Taqetuzumab CD3/GPRC5D bispecific antibody Multiple myeloma Johnson & Johnson; Genmab Zenidatuzumab Anti-HER2 bispecific antibody Biliary tract cancer Zymeworks; Jazz Pharmaceuticals; BeiGene Inalises PI3Kα inhibitor HR-positive breast cancer Roche; Chugai Pharmaceutical Asunitinib STAMP allosteric inhibitor Speculated use for chronic myeloid leukemia treatment Novartis Tazemetostat EZH2 inhibitor Follicular lymphoma Epizyme; Huadong Medicine; Eisai Relatuzumab-alpha PDL1/TGF-β bispecific antibody Stomach cancer; gastroesophageal junction cancer Hengrui Medicine; Dong-A Pharma Vabysmo EGFR antibody-drug conjugate Nasopharyngeal cancer Lepu Biopharma Tenapanor NHE3 inhibitor Chronic kidney disease hyperphosphatemia Ardelyx; Kyowa Kirin; Fosun Pharma; AstraZeneca Mersutide OXM analog; GLP-1R/GCGR agonist Obesity Eli Lilly; Innovent Biologics Vusirumab IL-1β monoclonal antibody Gouty arthritis Junshi Biosciences Romosozumab SOST monoclonal antibody Osteoporosis Astellas; Amgen; UCB Teplizumab CD3 monoclonal antibody Type 1 diabetes Ligand Pharmaceuticals; Johnson & Johnson; Sanofi Solrepinib Syk inhibitor Immune thrombocytopenic purpura Huadong Medicine BBM-H901 Factor IX gene therapy Hemophilia B Gene Therapy Fitusiran RNAi therapy Hemophilia A; Hemophilia B Sanofi; Alnylam Andexanet alfa Recombinant factor Xa Factor Xa inhibitor antidote Portola Pharmaceuticals Lisocabtagene maraleucel IL-23p19 monoclonal antibody Crohn's disease Boehringer Ingelheim; AbbVie Lemborexant & Daridorexant OX1R antagonist; OX2R antagonist Insomnia Eisai & Idorsia; Sihuan Pharmaceutical; Nxera Pharma Highlights of new drug approvals in 2024 include: 1. Oncology: The world’s first antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) for ovarian cancer: Mirvetuximab soravtansine. PD-1/VEGF bispecific antibody envafolimab and Nectin-4 ADC enfortumab vedotin. 2. Autoimmune diseases: IL-17A/F monoclonal antibody bimekizumab for ankylosing spondylitis. 3. Rare diseases: Novartis’ complement factor B inhibitor for paroxysmal nocturnal hemoglobinuria (PNH). Blockbuster drugs expected to be approved in 2025 include: Oncology: Amivantamab (Q1) The world’s first c-Met/EGFR bispecific antibody. Highlight: Phase III study showed significant extension of median progression-free survival (mPFS). Talquetamab (Q2) A CD3/GPRC5D bispecific antibody and the world’s first drug targeting GPRC5D. Clinical results: Objective response rate (ORR) in Chinese patients was 69.0%-73.6%. Zanidatamab (Q2) A HER2-targeting bispecific antibody based on Azymetric™ technology. Indication: HER2-positive biliary tract cancer (BTC) with an ORR of up to 52%. Inavolisib (Q3) Roche’s highly selective PI3Kα inhibitor for PIK3CA-mutated breast cancer. Asciminib (Q3) Novartis’ Bcr-Abl allosteric inhibitor for Philadelphia chromosome-positive chronic myeloid leukemia (CML). SHR-1701 (Q4) A PD-L1/TGF-βRII bifunctional fusion protein for first-line treatment of gastric cancer. Phase III study demonstrated significant extension in median overall survival. MRG003 (Q4) China’s first EGFR-targeting ADC with remarkable efficacy in nasopharyngeal carcinoma. Endocrinology and Metabolism: Tenapanor (Q1) The world’s only approved NHE3 inhibitor for controlling hyperphosphatemia in chronic kidney disease patients. Trend Analysis: Continued Innovation in Oncology: The emergence of multiple bispecific antibodies and ADC drugs is making targets and treatment options more precise and diverse. Breakthroughs in Autoimmune and Rare Diseases: New biologics are gradually addressing drug resistance and limited treatment options in previous therapies. Emergence of Domestic Innovative Drugs: Examples include SHR-1701 and MRG003, highlighting the growing research and development capabilities of Chinese pharmaceutical companies. The sequential launch of these drugs will provide new therapeutic options for Chinese patients and enhance China’s position in the global pharmaceutical market.

Drug ApprovalPhase 3Clinical ResultADCImmunotherapy

20 Dec 2024

·www.echemi.com

AstraZeneca's Andexxa Denied Full FDA Approval

Recently, AstraZeneca announced that the FDA has rejected its application for full approval of the drug Andexxa. Andexxa was submitted for market approval in China in December 2022. Initially, it received accelerated approval from the FDA in 2018 and conditional approval from the European Union in 2019. It is primarily used to treat acute bleeding caused by apixaban and rivaroxaban and is the only drug that can specifically reverse the activity of FXa inhibitors, hence being referred to as a "life-saving drug." In 2021, AstraZeneca acquired Alexion for $39 billion, which made Andexxa part of its product line. Reports indicate that Andexxa generated sales of $182 million in 2022, marking a 23% year-on-year increase. The FDA's reason for rejection was that the data provided by AstraZeneca revealed a "significant safety issue": the thrombosis-related mortality rate among patients using Andexxa was twice that of standard treatment. AstraZeneca stated that Andexxa will remain on the U.S. market and plans to collect further data to address the FDA's concerns. If subsequent data is unfavorable, there is a risk of withdrawal from the market. This decision could affect Andexxa's fate in other markets. Currently, its application for market approval in China is still pending, and in March next year, Andexxa's conditional approval in the EU may face stricter scrutiny. "Savage" Drug Reversal Agent With the rapid growth of Xa factor inhibitors such as rivaroxaban and apixaban in thrombotic treatment, these drugs have quickly replaced warfarin as the mainstream anticoagulants. In 2019, the combined sales of rivaroxaban and apixaban reached $16.4 billion, but complaints about bleeding events have also increased. As an antidote to reverse the anticoagulant effects of "saban" drugs, Andexxa can quickly reverse their impact. In 2020, Alexion acquired Andexxa for $1.4 billion, and it subsequently fell under AstraZeneca's umbrella. AstraZeneca has high hopes for Andexxa, with sales continuing to grow, reaching $182 million globally in 2023, a 24% year-on-year increase in the first three quarters. The company is advancing post-marketing clinical trials to seek comprehensive approval. Continuing to Seek Full Approval Industry insiders were surprised by the FDA's rejection. The ANNEXA-I trial conducted in June 2023 showed that Andexxa performed well in hemostatic capability, leading AstraZeneca to terminate the clinical trial early. However, the FDA advisory committee pointed out that the incidence of thrombosis significantly increased among patients using Andexxa. Nevertheless, the FDA's stance was not entirely resolute; committee members suggested modifying the indications and dosage to better assess Andexxa's safety. Currently, AstraZeneca plans to present complete efficacy and safety data at the upcoming medical conference. If supplemental data supports its safety, Andexxa's future remains promising.

Drug ApprovalAcquisitionClinical StudyAccelerated Approval

17 Dec 2024

·www.fiercepharma.com

FDA rejects J&J's subcutaneous Rybrevant filing and AZ's full approval bid for Andexxa

The FDA has sent complete response letters to Johnson & Johnson, rejecting its subcutaneous version of Rybrevant, and to AstraZeneca, giving a thumbs down to its bid for full approval of Andexxa. Johnson & Johnson has received coal in its stocking from the FDA as manufacturing issues have tripped up the company’s attempt to gain approval of its subcutaneous version of lung cancer drug Rybrevant (amivantamab).The U.S. regulator sent J&J a complete response letter (CRL) rejecting its application to clear Rybrevant’s injected formulation for patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.The FDA also has sent a CRL to AstraZeneca, swatting its request for full approval of Andexxa, which reverses the anticoagulant effect of blood thinners. The thumbs down was not a surprise as it came three weeks after an FDA advisory panel questioned Andexxa’s safety profile.The rejection for J&J was based on observations FDA officials made at a manufacturing facility during a standard pre-approval inspection. The CRL is not related to the formulation of the treatment or its efficacy or safety, the company explained in a release. The agency has not asked J&J to conduct an additional clinical study and its current approval for Rybrevant’s intravenous remains unaffected, the drugmaker added.“We’re working closely with the FDA to bring SC amivantamab to patients as quickly as possible, and are confident in our path to resolution,” Yusri Elsayed, M.D., Ph.D., J&J’s global therapeutic area head for oncology, said in a release. There has been much anticipation for Rybrevant’s injected version since the company reported seven months ago that it had performed better than intravenous Rybrevant in a clinical trial, reducing the risk of death by 38%.In August, the FDA approved Rybrevant and Lazcluse as a first-line treatment for NSCLC with EFGR mutations. A win for SC Rybrevant could help J&J in its challenge against AZ’s EGFR standout Tagrisso, which is an oral drug. While IV Rybrevant can take up to five hours to administer, the SC version only takes up to seven minutes or five minutes at median. As for the FDA's rejection of Andexxa, the company said in an email that it will keep the treatment on the market in the U.S. AZ confirmed the CRL, which was reported last week by Pink Sheet.In the first nine months of this year, Andexxa generated U.S. sales of $61 million and $159 million worldwide, which was up 24% year over year. It has been on the market since 2018 when Portola Pharmaceuticals scored its accelerated approval.In 2020, Alexion bought out Portola in a much-criticized $1.4 billion deal. A year later, AZ acquired Alexion.

Drug ApprovalAcquisitionAccelerated Approval

100 Deals associated with Andexanet alfa

External Link

KEGG	Wiki	ATC	Drug Bank
D11029	Andexanet alfa	V03AB38	DB14562

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hemorrhage	United States	Portola Pharmaceuticals LLC	03 May 2018
Hemorrhage	United States	AstraZeneca AB	03 May 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Massive hemorrhage	Phase 3	-	AstraZeneca PLC	02 Aug 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ATS2025	Not Applicable	Upper gastrointestinal hemorrhage	320	Andexanet Alpha	sexykkkiei(feithojbcs): HR = 1.5 (95% CI, 0.93 - 2.33), P-Value = 0.09 View more	Negative	16 May 2025
				Protein Complex Concentrate (PCC)
NCT03661528 (ANNEXA-I Biomarker Substudy, Pubmed \| Stroke)	Phase 4	Intracranial Hemorrhages anti-FXa activity \| endogenous thrombin potential (ETP)	530	Andexanet	xxhhcchyhs(hyoebafktr) = jiiryvirzy jjsqbliuuk (qeatmlengn )	Positive	28 Apr 2025
NCT03661528 (ANNEXA-I Biomarker Substudy \| ANNEXA-I, CTgov)	Phase 4	Intracranial Hemorrhages	530	andexanet alfa (Andexanet Alfa)	cqycvmvdse = dhywjapamm bcepjbvxaq (hceogzcnkl, gxfvrcdyge - cembkjtgix) View more	-	03 Jul 2024
				Usual Care (Usual Care)	cqycvmvdse = llkbdsdjaj bcepjbvxaq (hceogzcnkl, oojbljxubz - cpnhhinajm) View more
NCT03661528 (Pubmed) Manual	Phase 4	Cerebral Hemorrhage	530	Andexanet alfa	vcrqzyucpc(vysgassnhy) = fjxvapnarf jpnygnnrlt (plpwgnywme ) View more	Positive	16 May 2024
				Andexanet (Usual care)	vcrqzyucpc(vysgassnhy) = hyqndtukqm jpnygnnrlt (plpwgnywme ) View more
ISTH2023	Not Applicable	Hemorrhage factor Xa (FXa) inhibitors rivaroxaban \| apixaban	-	Andexanet alfa	jqikcyrcky(gdqskgvcvw) = wudfyuombf tboqjxophq (vymsllxqzn ) View more	-	24 Jun 2023
				4-factor prothrombin complex concentrate	jqikcyrcky(gdqskgvcvw) = iqgcxqtezx tboqjxophq (vymsllxqzn ) View more
ISTH2023	Not Applicable	Hemorrhage	-	Andexanet alfa	uxqlchiexx(trkrytgfdg) = npkyskviyd hxmrytkkmm (qknuprzcau )	-	24 Jun 2023
				4-Factor Prothrombin Complex Concentrate (4F-PCC)	uxqlchiexx(trkrytgfdg) = uuwjtkbavp hxmrytkkmm (qknuprzcau )
NCT02329327 (ANNEXA-4, Pubmed \| Circulation)	Phase 3	Hemorrhage	479	Andexanet alfa	mdadqktcka(dkxyvwavql) = uezmzjuzno lxjqmlezin (zzjykbqblp, 10.0)	-	20 Feb 2023
NCT02329327 (Pubmed \| Crit Care)	Phase 3	Intracranial Hemorrhages	-	Andexanet alfa	mejnmjnxzt(bwugijwsbg) = aluoiahpgh mkzxrnwhak (yqzixxodan ) View more	-	16 Jun 2022
				Four-factor prothrombin complex concentrate (4F-PCC)	mejnmjnxzt(bwugijwsbg) = kwvfubagxf mkzxrnwhak (yqzixxodan ) View more
NCT02329327 \| NCT03093233 (ANNEXA-4, Pubmed \| Stroke)	Phase 3	Cerebral Hemorrhage	182	Andexanet alfa	muobxccmda(bfyojvwacs) = hnwasysivf oeozjdvtxg (jonmgdvrsf )	-	14 Oct 2021
				Usual care (primarily administration of prothrombin complex concentrates)	muobxccmda(bfyojvwacs) = guhltrblbs oeozjdvtxg (jonmgdvrsf )
ISC2021	Not Applicable	Hemorrhage	-	Idarucizumab	pfmzyfamjk(eahwfsivow) = cqjkcqbbty ucxayqdgzq (adkzwizxnz )	-	01 Mar 2021
				Andexanet Alfa	pfmzyfamjk(eahwfsivow) = cpiroxohgg ucxayqdgzq (adkzwizxnz )

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