Akt-1 inhibitors(Serine/threonine-protein kinase AKT1 inhibitors), Akt-2 inhibitors(Serine/threonine-protein kinase AKT2 inhibitors), Akt-3 inhibitors(Serine/threonine-protein kinase AKT3 inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesImmune System Diseases+ [6]

Active Indication

Hormone receptor positive HER2 negative breast cancerFallopian Tube CarcinomaOvarian Cancer+ [13]

Inactive Indication

Advanced Malignant Solid NeoplasmHER2 negative Gastric CancerHistiocytosis, Langerhans-Cell+ [3]

Originator Organization

GSK Plc

Active Organization

Halo Pharmaceutical, Inc.

Laekna Therapeutics (Shanghai) Co., Ltd.

Laekna Ltd.

+ [2]

Inactive Organization

Novartis Pharmaceuticals Corp.

Novartis AG

Novartis Pharmaceuticals Canada, Inc.

License Organization

Laekna Ltd.

Laekna Therapeutics (Shanghai) Co., Ltd.

Novartis AG

+ [3]

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

Structure/Sequence

Molecular FormulaC18H17Cl2FN4OS

InChIKeyAFJRDFWMXUECEW-LBPRGKRZSA-N

CAS Registry1047644-62-1

Clinical Trials associated with Afuresertib

CTR20253541

/ RecruitingPhase 1

一项在健康参与者中评价 Afuresertib药物-药物相互作用（DDI）的单中心、非随机、开放、自身对照临床试验

[Translation] A single-center, non-randomized, open-label, self-controlled clinical trial evaluating the drug-drug interaction (DDI) of afuresertib in healthy participants

主要研究目的：评价利福平对 Afuresertib 药代动力学的影响；评价伊曲康唑对 Afuresertib 药代动力学的影响；评价 Afuresertib 对咪达唑仑药代动力学的影响。次要研究目的：评价 Afuresertib 单独使用和与利福平合用时其代谢产物 M14、M28 的药代动力学特征；评价 Afuresertib 单独使用和与伊曲康唑合用时其代谢产物 M14、M28 的药代动力学特征；评价咪达唑仑单独使用和与 Afuresertib 合用时其代谢产物 1-羟基咪达唑仑的药代动力学特征；评价 Afuresertib 单独使用和与利福平合用时在健康参与者中的安全性；评价 Afuresertib 单独使用和与伊曲康唑合用时在健康参与者中的安全性；评价 Afuresertib 与咪达唑仑合用时在健康参与者中的安全性；评价 Afuresertib 在咪达唑仑 DDI 研究中多次给药后的 PK 特征。

[Translation]

Primary study objectives: To evaluate the effect of rifampicin on the pharmacokinetics of afuresertib; To evaluate the effect of itraconazole on the pharmacokinetics of afuresertib; To evaluate the effect of afuresertib on the pharmacokinetics of midazolam. Secondary study objectives: To evaluate the pharmacokinetic profiles of afuresertib's metabolites, M14 and M28, when used alone and in combination with rifampicin; To evaluate the pharmacokinetic profiles of afuresertib's metabolites, M14 and M28, when used alone and in combination with itraconazole; To evaluate the pharmacokinetic profiles of its metabolite, 1-hydroxymidazolam, when used alone and in combination with afuresertib; To evaluate the safety of afuresertib when used alone and in combination with rifampicin in healthy subjects; To evaluate the safety of afuresertib when used alone and in combination with itraconazole in healthy subjects; To evaluate the safety of afuresertib when used in combination with midazolam in healthy subjects; To evaluate the PK profile of afuresertib after repeated dosing in a midazolam DDI study.

Start Date21 Sep 2025

Sponsor / Collaborator

Laekna Pharmaceutical Ningbo Co., Ltd,

CTR20253540

/ RecruitingPhase 1

在中国健康参与者中单次口服 Afuresertib 片的单中心、随机、双盲设计的食物影响、对 QT/QTc 间期的影响及安全性试验

[Translation] A single-center, randomized, double-blind trial of the food effect, QT/QTc interval, and safety of afuresertib tablets in healthy Chinese participants

食物影响研究：主要目的：评价健康参与者在空腹和进食高脂餐状态下单次口服 Afuresertib 片的药代动力学特征以及食物对 Afuresertib 片药代动力学的影响。次要目的：评价 Afuresertib 片单次口服给药后其代谢产物 M14、M28 在健康参与者中的药代动力学特征；评价健康参与者在空腹和进食高脂餐状态下单次口服 Afuresertib 片的安全性。 C-QTc 研究：主要目的：评价 Afuresertib 片单次口服给药后对健康参与者 QT/QTc 间期的影响。次要目的：评价 Afuresertib 片单次口服给药后对健康参与者其它 ECG 参数（HR、PR、QRS 间期、T 波形态和 U 波存在等）的影响；评价 Afuresertib 片单次口服给药后 Afuresertib 及其代谢产物 M14、M28 在健康参与者中的药代动力学特征；评价 Afuresertib 片单次口服给药后在健康参与者中的安全性。

[Translation]

Food Effect Study: Primary Objective: To evaluate the pharmacokinetic characteristics of afuresertib tablets after a single oral dose in healthy participants in the fasting and high-fat meal states, and the effect of food on the pharmacokinetics of afuresertib tablets. Secondary Objectives: To evaluate the pharmacokinetic characteristics of afuresertib tablets and their metabolites, M14 and M28, in healthy participants after a single oral dose; To evaluate the safety of afuresertib tablets after a single oral dose in healthy participants in the fasting and high-fat meal states. C-QTc Study: Primary Objective: To evaluate the effect of a single oral dose of afuresertib tablets on the QT/QTc interval in healthy participants. Secondary objectives: To evaluate the effects of a single oral dose of afuresertib tablets on other ECG parameters (HR, PR, QRS interval, T wave morphology, and U wave presence) in healthy participants; To evaluate the pharmacokinetic characteristics of afuresertib and its metabolites M14 and M28 in healthy participants after a single oral dose of afuresertib tablets; To evaluate the safety of afuresertib tablets in healthy participants after a single oral dose.

Start Date19 Sep 2025

Sponsor / Collaborator

Laekna Pharmaceutical Ningbo Co., Ltd,

CTR20252279

/ Active, not recruitingNot Applicable

评估不同产地不同规格的Afuresertib 片剂在空腹状态下中国健康成年受试者中的单中心、开放、随机、单剂量、两周期、两序列、双交叉的生物等效性

[Translation] To evaluate the bioequivalence of Afuresertib tablets of different strengths from different origins in Chinese healthy adult subjects in the fasting state in a single-center, open-label, randomized, single-dose, two-period, two-sequence, double-crossover

研究空腹状态下单次口服受试制剂Afuresertib片剂（境内生产）（规格：50 mg与75 mg）与参比制剂Afuresertib 片剂（境外生产）（规格：50 mg 与75 mg）在中国健体内的药代动力学，评价空腹状态口服不同产地制剂的生物等效性。

[Translation]

The pharmacokinetics of a single oral dose of the test preparation Afuresertib tablets (produced domestically) (strengths: 50 mg and 75 mg) and the reference preparation Afuresertib tablets (produced overseas) (strengths: 50 mg and 75 mg) in Chinese healthy people were studied under fasting state, and the bioequivalence of oral preparations from different origins under fasting state was evaluated.

Start Date02 Jul 2025

Sponsor / Collaborator

Laekna Pharmaceutical Ningbo Co., Ltd,

100 Clinical Results associated with Afuresertib

100 Translational Medicine associated with Afuresertib

100 Patents (Medical) associated with Afuresertib

Literatures (Medical) associated with Afuresertib

01 Dec 2025·iScience

Organoid platinum-resistance model identifies KRT17 as a biomarker of targeted therapy in ovarian cancer

Article

Author: Fischer, Jonas ; Chelariu-Raicu, Anca ; Mayr, Doris ; Trillsch, Fabian ; Mahner, Sven ; Hierlmayer, Sophia ; Olsen, Jesper V ; Burges, Alexander ; Piga, Ilaria ; Vasovic, Nemanja ; Kraus, Fabian ; Czogalla, Bastian ; Schmid, Juliana ; Geweniger, Sophia ; Straub, Tobias ; Reichenbach, Juliane ; Kessler, Mirjana ; Davesar, Aarushi ; Zhang, Tingyu ; Klein, Christoph

Video abstract:

01 Nov 2025·BIOMEDICINE & PHARMACOTHERAPY

Inhibition of AKT or mTOR molecules mitigates obesity-associated metabolic disorders in Riz1 mice with obesity

Article

Author: Xie, Xiaolei ; Zhang, Jinghong ; Li, Jiaxing ; Ye, Huiru ; Yin, Weiguo ; Yan, Jiahui

The deficiency of the tumor suppressor factor RIZ1 can lead to obesity with activation of the V-Akt murine thymoma viral oncogene homolog (PKB) (AKT)/mechanistic target of rapamycin (mTOR) pathway. The aim of this study was to elucidate the role of RIZ1 in obesity through the inhibition of the AKT or mTOR pathway. Riz1 knockout mice (KO) were randomly treated with either the AKT inhibitor afuresertib or the mTOR inhibitor rapamycin. The survival rate in the afuresertib-treated group was lower than that in the rapamycin-treated group. Both afuresertib and rapamycin significantly reduced weight gain and hepatic steatosis in KO mice. Metabolic cage analysis of inhibitor-treated KO mice revealed increased oxygen consumption and enhanced lipid utilization. The inhibitor-treated mice exhibited improved glucose regulation and enhanced insulin sensitivity, which was accompanied by reduced blood glucose and insulin levels. Serum triglyceride levels were significantly reduced in inhibitor-treated groups. Mice treated with the inhibitors exhibited significantly suppressed AKT/mTOR signaling pathway in liver, muscle, and adipose tissues, as well as downregulation of genes associated with energy and lipid metabolism (L-Fabp, Pparα/γ, Ubiad1, Cyp4a12). These findings demonstrate that inhibition of either the AKT or mTOR molecules mitigates obesity and metabolic dysregulation in Riz1^-/- mice, highlighting the critical role of the RIZ1/AKT/mTOR axis in maintaining metabolic homeostasis.

01 Apr 2025·MOLECULAR DIVERSITY

An in silico approach to identify novel and potential Akt1 (protein kinase B-alpha) inhibitors as anticancer drugs

Article

Author: Etikyala, Umadevi ; Dalimba, Udayakumar ; Manga, Vijjulatha ; Reddyrajula, Rajkumar ; Kuchana, Vinutha ; Vani, T

Akt1 (protein kinase B) has become a major focus of attention due to its significant functionality in a variety of cellular processes and the inhibition of Akt1 could lead to a decrease in tumour growth effectively in cancer cells. In the present work, we discovered a set of novel Akt1 inhibitors by using multiple computational techniques, i.e. pharmacophore-based virtual screening, molecular docking, binding free energy calculations, and ADME properties. A five-point pharmacophore hypothesis was implemented and validated with AADRR38. The obtained R² and Q² values are in the acceptable region with the values of 0.90 and 0.64, respectively. The generated pharmacophore model was employed for virtual screening to find out the potential Akt1 inhibitors. Further, the selected hits were subjected to molecular docking, binding free energy analysis, and refined using ADME properties. Also, we designed a series of 6-methoxybenzo[b]oxazole analogues by comprising the structural characteristics of the hits acquired from the database. Molecules D1-D10 were found to have strong binding interactions and higher binding free energy values. In addition, Molecular dynamic simulation was performed to understand the conformational changes of protein-ligand complex.

News (Medical) associated with Afuresertib

14 Jan 2026

·www.laekna.com

A Novel PI3Kα Pan-Mutant Selective Inhibitor | Laekna Announced FDA Acceptance of Investigational New Drug Application for LAE118

- LAE118 is a novel allosteric inhibitor which demonstrated excellent potency and selectivity against various PI3Kα pan-mutant, with best-in-class potential - Building on its proven track record in successfully developing and out-licensing LAE002 (afuresertib), Laekna is actively advancing LAE118 to clinical studies Jan 14, 2026 — Laekna, Inc. (2105.HK) today announced that the U.S. Food and Drug Administration （FDA）has accepted its Investigational New Drug application for LAE118, a novel PI3Kα pan-mutant selective inhibitor for the treatment of patients with PIK3CA-mutant solid tumors. PI3Kα mutations are common in multiple cancers including breast, colorectal, lung, endometrial. However, the currently approved PI3Kα inhibitors non-selectively target both wild-type and mutant PI3Kα, which leads to significant tolerability issues and high risk of resistance development. Dr. Justin Gu, Chief Scientific Officer of Laekna, said: “LAE118 is an our internally discovered drug candidate for treatment of cancer and is advancing to clinical stage of development. LAE118 is a novel allosteric inhibitor that demonstrates excellent potency and selectivity against a board range of PI3Kα mutants. It has shown superior efficacy and a more favorable safety profile in the preclinical studies which demonstrated its best-in-class potential. The preclinical data of LAE118 were presented at the San Antonio Breast Cancer Symposium in December 2024”. Mr. Keith Chau, Chief Financial Officer of Laekna, said: “We have completed patient enrollment in the phase III clinical trial AFFIRM-205 for LAE002 (afuresertib, an oral AKT inhibitor) in December 2025 and target to readout the topline data in the first half of 2026, followed by submission of NDA to CDE later in the year. The Group also entered into an exclusive licensing agreement with Qilu Pharma to accelerate the commercialization for LAE002 (afuresertib). Building on our proven track record in successfully developing and out-licensing LAE002 (afuresertib), we are actively advancing LAE118 to clinical studies and aim to bring this precision therapy to patients who are in need of novel treatment options”. – End – Contact Us IR ir@laekna.com Corporate and Business Development BD@laekna.com About LAE118 LAE118 is a novel PI3Kα pan-mutant selective inhibitor. The company is actively advancing this drug candidate to clinical studies as novel therapies for PIK3CA-mutant solid tumors. About Laekna Stock Code: 2105.HK Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapeutics to patients with metabolic diseases, cancer and liver fibrosis around the world. As of June 30, 2025, Laekna has initiated seven clinical trials for LAE102, LAE002 (afuresertib) and other drug candidates to address unmet medical needs in obesity and cancers. LAE102 is our internally discovered antibody against ActRIIA. Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass, this positions LAE102 as a promising drug candidate for achieving quality weight control. We are advancing the Phase I clinical trials for obesity indication in both China and the U.S. In November 2024, Laekna entered into a clinical collaboration agreement with Eli Lilly and Company to support and accelerate global clinical development of LAE102 for the treatment of obesity. In addition to LAE102, LAE103 is our internally discovered ActRIIB-selective antibody, LAE123 is an ActRIIA/IIB dual antagonistic monoclonal antibody. Laekna has established a comprehensive ActRII portfolio and is actively advancing these drug candidates to clinical studies as novel therapies for muscle and other disease indications. In the cancer area, Laekna has built a comprehensive portfolio of drug candidates including LAE002(afuresertib), LAE001 and other clinical and pre-clinical drug candidates. LAE002 (afuresertib) is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in late-stage development for breast and prostate cancer globally. Laekna has commenced the Phase III clinical trial (AFFIRM-205) for LAE002 in patients with HR+/HER2- breast cancer and the study recruitment is on track. Laekna, Inc. (2105.HK) was listed on the Main Board of The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange”) on June 29, 2023. For more information, please visit: https://www.laekna.com/ or https://www.linkedin.com/company/74110713/ Forward-Looking Statements This press release may contain certain “forward-looking statements” which are not historical facts, but instead are predictions about future events based on Laekna’s current beliefs, assumptions and expectations, commonly identified by words such as "would", "may", "expects", "believes", "plans", "intends", "projects" and other terms with similar meaning. Although we believe that our predictions are reasonable, future events are inherently uncertain and our actual future results or performance may be materially different from what we expect. Accordingly, you are strongly cautioned that reliance on any forward-looking statements is subject to significant known and unknown risks and uncertainties. All forward-looking statements contained herein are qualified by reference to the cautionary statements set forth in this section. All information provided in this press release is as of the date of this press release and are based on assumptions that we believe to be reasonable as of this date, and we do not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Phase 3Phase 1License out/inPhase 2

31 Dec 2025

·www.laekna.com

Laekna Announced First Subject Dosed in Phase I Single Ascending Dose Study of LAE103

Dec 31, 2025 —Laekna, Inc. (2105.HK) today announced that the company has commenced study recruitment in phase I single ascending dose study (the “SAD study”) of LAE103, an internally discovered monoclonal antibody against ActRIIB in Australia. As of the date of this announcement, first subject has been dosed. The SAD study is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of LAE103, administered subcutaneously, in healthy overweight or obese participants. The company targets to read out the topline data of this SAD study in the third quarter of 2026. LAE103 is an ActRIIB selective antibody. The company targets to bring this precision therapy to cardiovascular and metabolic diseases with high unmet medical needs, such as obesity, sarcopenia and heart failure, etc. Laekna team has accumulated tremendous experiences and extensive knowhow in the specific area of targeting ActRII receptors and is developing more drug candidates to maximize the value of the target. The preliminary results of the Phase I MAD study of LAE102 (ActRIIA monoclonal antibody) was announced in September 2025 which demonstrated an encouraging trend towards lean body mass increase and fat mass reduction, a well-tolerated safety profile and robust PK/PD (Read more). LAE123 is a dual inhibitor against ActRIIA/IIB and has advanced to IND-enabling studies. – End – Contact Us IR ir@laekna.com Corporate and Business Development BD@laekna.com About Laekna Stock Code: 2105.HK Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapeutics to patients with metabolic diseases, cancer and liver fibrosis around the world. As of June 30, 2025, Laekna has initiated seven clinical trials for LAE102, LAE002 (afuresertib) and other drug candidates to address unmet medical needs in obesity and cancers. LAE102 is our internally discovered antibody against ActRIIA. Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass, this positions LAE102 as a promising drug candidate for achieving quality weight control. We are advancing the Phase I clinical trials for obesity indication in both China and the U.S. In November 2024, Laekna entered into a clinical collaboration agreement with Eli Lilly and Company to support and accelerate global clinical development of LAE102 for the treatment of obesity. In addition to LAE102, LAE103 is our internally discovered ActRIIB-selective antibody, LAE123 is an ActRIIA/IIB dual antagonistic monoclonal antibody. Laekna has established a comprehensive ActRII portfolio and is actively advancing these drug candidates to clinical studies as novel therapies for muscle and other disease indications. In the cancer area, Laekna has built a comprehensive portfolio of drug candidates including LAE002(afuresertib), LAE001 and other clinical and pre-clinical drug candidates. LAE002 (afuresertib) is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in late-stage development for breast and prostate cancer globally. Laekna has commenced the Phase III clinical trial (AFFIRM-205) for LAE002 in patients with HR+/HER2- breast cancer and the study recruitment is on track. Laekna, Inc. (2105.HK) was listed on the Main Board of The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange”) on June 29, 2023. For more information, please visit: https://www.laekna.com/ or https://www.linkedin.com/company/74110713/ Forward-Looking Statements This press release may contain certain “forward-looking statements” which are not historical facts, but instead are predictions about future events based on Laekna’s current beliefs, assumptions and expectations, commonly identified by words such as "would", "may", "expects", "believes", "plans", "intends", "projects" and other terms with similar meaning. Although we believe that our predictions are reasonable, future events are inherently uncertain and our actual future results or performance may be materially different from what we expect. Accordingly, you are strongly cautioned that reliance on any forward-looking statements is subject to significant known and unknown risks and uncertainties. All forward-looking statements contained herein are qualified by reference to the cautionary statements set forth in this section. All information provided in this press release is as of the date of this press release and are based on assumptions that we believe to be reasonable as of this date, and we do not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Phase 1Phase 3Phase 2

22 Dec 2025

·www.laekna.com

Laekna Announced First Subject Dosed in Phase I Multiple Dose Expansion Study of LAE102 for the Treatment of Obesity

Dec 22, 2025 —Laekna, Inc. (2105.HK) today announced that following the positive results observed in the Phase I MAD study, the company has commenced study recruitment in Phase I Multiple Dose Expansion study of LAE102 in China for the treatment of obesity and the first subject has been dosed. The Phase I Multiple Dose Expansion study is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of LAE102, administered subcutaneously, in 60 overweight/obese subjects. Enrolled subjects will be randomized into LAE102 or placebo for a 6-month treatment. The preliminary results of the Phase I MAD study of LAE102 (administered subcutaneously weekly for 5 weeks) demonstrated an encouraging trend towards lean body mass increase and fat mass reduction, a well-tolerated safety profile and robust PK/PD (Read more). The pre-planned study was initiated to further evaluate the efficacy and safety profile of LAE102 over a longer treatment duration (6 months). – End – Contact Us IR ir@laekna.com Corporate and Business Development BD@laekna.com About LAE102 LAE102 is an internally discovered monoclonal antibody selectively targeting ActRIIA, a receptor that plays an important role in muscle regeneration and lipid metabolism. In the pre-clinical models, LAE102 has been shown to increase lean mass and decrease fat mass. In combination with GLP1R agonist, LAE102 can further reduce fat mass and significantly regain the lean mass loss induced by GLP1R agonist. This positions LAE102 as a promising drug candidate for achieving quality weight control. About Laekna Stock Code: 2105.HK Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapeutics to patients with metabolic diseases, cancer and liver fibrosis around the world. As of June 30, 2025, Laekna has initiated seven clinical trials for LAE102, LAE002 (afuresertib) and other drug candidates to address unmet medical needs in obesity and cancers. LAE102 is our internally discovered antibody against ActRIIA. Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass, this positions LAE102 as a promising drug candidate for achieving quality weight control. We are advancing the Phase I clinical trials for obesity indication in both China and the U.S. In November 2024, Laekna entered into a clinical collaboration agreement with Eli Lilly and Company to support and accelerate global clinical development of LAE102 for the treatment of obesity. In addition to LAE102, LAE103 is our internally discovered ActRIIB-selective antibody, LAE123 is an ActRIIA/IIB dual antagonistic monoclonal antibody. Laekna has established a comprehensive ActRII portfolio and is actively advancing these drug candidates to clinical studies as novel therapies for muscle and other disease indications. In the cancer area, Laekna has built a comprehensive portfolio of drug candidates including LAE002(afuresertib), LAE001 and other clinical and pre-clinical drug candidates. LAE002 (afuresertib) is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in late-stage development for breast and prostate cancer globally. Laekna has commenced the Phase III clinical trial (AFFIRM-205) for LAE002 in patients with HR+/HER2- breast cancer and the study recruitment is on track. Laekna, Inc. (2105.HK) was listed on the Main Board of The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange”) on June 29, 2023. For more information, please visit: https://www.laekna.com/ or https://www.linkedin.com/company/74110713/ Forward-Looking Statements This press release may contain certain “forward-looking statements” which are not historical facts, but instead are predictions about future events based on Laekna’s current beliefs, assumptions and expectations, commonly identified by words such as "would", "may", "expects", "believes", "plans", "intends", "projects" and other terms with similar meaning. Although we believe that our predictions are reasonable, future events are inherently uncertain and our actual future results or performance may be materially different from what we expect. Accordingly, you are strongly cautioned that reliance on any forward-looking statements is subject to significant known and unknown risks and uncertainties. All forward-looking statements contained herein are qualified by reference to the cautionary statements set forth in this section. All information provided in this press release is as of the date of this press release and are based on assumptions that we believe to be reasonable as of this date, and we do not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Phase 1Phase 3Phase 2Clinical Result

100 Deals associated with Afuresertib

External Link

KEGG	Wiki	ATC	Drug Bank
D10381	-	-	DB11648

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hormone receptor positive HER2 negative breast cancer	Phase 3	United States	Laekna Ltd.	18 Feb 2022
Hormone receptor positive HER2 negative breast cancer	Phase 3	China	Laekna Ltd.	18 Feb 2022
Locally Advanced Esophageal Squamous Cell Carcinoma	Phase 2	China	Laekna Therapeutics (Shanghai) Co., Ltd.	01 Jul 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 2	China	Laekna Therapeutics (Shanghai) Co., Ltd.	01 Jul 2022
Uterine Cervix Adenocarcinoma	Phase 2	China	Laekna Therapeutics (Shanghai) Co., Ltd.	01 Jul 2022
Bile Duct Neoplasms	Phase 2	China	Halo Pharmaceutical, Inc.	22 Jun 2022
Bile Duct Neoplasms	Phase 2	China	Laekna Therapeutics (Shanghai) Co., Ltd.	22 Jun 2022
Endometrial Carcinoma	Phase 2	China	Laekna Therapeutics (Shanghai) Co., Ltd.	22 Jun 2022
Endometrial Carcinoma	Phase 2	China	Halo Pharmaceutical, Inc.	22 Jun 2022
Gastroesophageal junction adenocarcinoma	Phase 2	China	Laekna Therapeutics (Shanghai) Co., Ltd.	22 Jun 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05383482 (IGCS2024) Manual	Phase 1/2	Solid tumor \| Endometrial Carcinoma \| Uterine Cervical Cancer	18	Afuresertib + Sintilimab + Nab-paclitaxel	yjeznzwseq(pdnsrkkcih) = alqgizbmmg vhzlzhqfza (pftfvxnjjk, 31.6 - 86.1) View more	Positive	16 Oct 2024
NCT04851613 (NEWS) Manual	Phase 1	Hormone receptor positive HER2 negative breast cancer HR Positive \| HER2 Negative	18	LAE002 (afuresertib) plus fulvestrant (PIK3CA/AKT1/PTEN alteration)	rwyheikfst(diemtovvri) = usldwfvckk ruiqzjuawx (crieqhqmhs ) View more	Positive	19 Sep 2024
NCT04851613 (ESMO2024) Manual	Phase 1	Hormone receptor positive HER2 negative breast cancer HER2 Negative \| HR Positive ... View more	31	Afuresertib plus fulvestrant	zxoanjlevl(cqvidgwovw) = mxgibxzgun thyxohtjcw (ftsgoalvvu ) View more	Positive	16 Sep 2024
NCT04851613 (ESMO2024) Manual	Phase 1		31	afuresertib (PIK3CA/AKT1/PTEN-altered subjects)	zxoanjlevl(cqvidgwovw) = gngzkuspts thyxohtjcw (ftsgoalvvu ) View more	Positive	16 Sep 2024
NCT05390710 (AACR2024) Manual	Phase 1/2	Solid tumor \| Triple Negative Breast Cancer	22	afuresertibAfuresertib 100 mgLAE005 10nab-paclitaxelNab-paclitaxel 125 mg/m2	bhugfdngdz(vzgihiembm) = iwkemdithp liqpdofsnf (hhdghbtigs ) View more	Positive	05 Apr 2024
NCT04374630 (PROFECTA II, Corporate Publications) Manual	Phase 2	Platinum-Resistant Ovarian Carcinoma	150	Afuresertib+Paclitaxel	fzmdzxybbs(enklbizefo): HR = 0.744 (95% CI, 0.502 - 1.102) Not Met	Negative	28 Jan 2024
NCT04374630 (PROFECTA II, Corporate Publications) Manual	Phase 2	Platinum-Resistant Ovarian Carcinoma	150	Paclitaxel		Negative	28 Jan 2024
NCT04060394 (ESMO 12023 \| ESMO 22023) Manual	Phase 1/2	Metastatic castration-resistant prostate cancer	40	LAE001+prednisone+ afuresertib	fluxvnhxvx(zathqkirhy) = thrombocytopenia (7.5%), anaemia (5.0%), hyperglycaemia (5.0%), hyponatraemia (5.0%), and hypertension (5.0%). SAEs were reported in 9 patients (22.5%), 5 (12.5%) were assessed as related to study treatment kpgyeslglm (kzfasaqamv )	Positive	22 Oct 2023
NCT01531894 (CTgov)	Phase 2	Solid tumor \| Hematologic Neoplasms	11	GSK2110183 (afuresertib)	tsruclseuu = wmdzkjqhag zawlqxoeny (ckmqyvuvyf, xsoyrzthji - yupqkvxzyx)	-	09 Jul 2019
NCT01653912 (Pubmed \| Clin Cancer Res)	Phase 1/2	Recurrent Platinum-Resistant Ovarian Carcinoma	59	Afuresertib	vnlqtyfxzv(exgnpgxexx) = uvbdolnmkf hpofnzupsj (ntgtpndtey, 15.9 - 52.4) View more	-	01 Mar 2019
NCT01653912 (Pubmed \| Clin Cancer Res)	Phase 1/2	Recurrent Platinum-Resistant Ovarian Carcinoma	59	Carboplatin and Paclitaxel	vnlqtyfxzv(exgnpgxexx) = cluxnkwnnd hpofnzupsj (ntgtpndtey, 31.3 - 72.2)	-	01 Mar 2019
NCT01653912 (CTgov)	Phase 1/2	Platinum-Resistant Ovarian Carcinoma \| Recurrent Platinum-Resistant Ovarian Carcinoma	59	GSK2110183 (Phase 1 (Dose Escalation): GSK2110183)	nxwqbgfapj = ddrfuycrkk lzaqhgnmcg (bkukghlmnx, qldvzhocgb - npqycfgcnw) View more	-	02 Apr 2018
NCT01653912 (CTgov)	Phase 1/2		59	GSK2110183 (Phase 2 (Treatment Group): GSK2110183)	mdxvlslisd = cpcyhobuai sqzqfmgbbp (hotzawolcv, mppoxavkky - jnwngobgso) View more	-	02 Apr 2018
NCT01653912 (ASCO2016)	Phase 1/2	Recurrent ovarian cancer	59	Afuresertib + Paclitaxel + Carboplatin	bfwwzbpgih(xpgzbgpvll) = G3/4 AEs included diarrhea (20%), fatigue (10%), rash (10%), vomiting (7%), and nausea (3%) ypepwoljfj (oqghaeqyoi )	Positive	20 May 2016

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