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Last update 17 Jan 2026

Erlotinib Hydrochloride

Last update 17 Jan 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

[6,7-Bis-(2-methoxy-ethoxy)-quinazolin-4-yl]-(3-ethynyl-phenyl)-amine, ERLOTINIB, Erlotinib hydrochloride (JAN/USAN)

+ [20]

Target

EGFR L858R x EGFR-Ex19del

Action

inhibitors

Mechanism

EGFR exon 19 deletion inhibitors, EGFR exon 21 L858R mutation inhibitors

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [5]

Active Indication

EGFR positive non-small cell lung cancerNon-Small Cell Lung CancerPancreatic Cancer+ [21]

Inactive Indication

Acute Myeloid LeukemiaAcute Myelomonocytic LeukemiaAcute Promyelocytic Leukemia+ [131]

Originator Organization

OSI Pharmaceuticals, Inc.

Pfizer Inc.

Active Organization

Roche Pharma (Schweiz) AG

Chugai Pharmaceutical Co., Ltd.

Roche Holding AG

+ [11]

Inactive Organization

OSI Pharmaceuticals, Inc.

Hoffmann-La Roche, Inc.

Bristol Myers Squibb Co.

+ [18]

License Organization

Shanghai Roche Pharmaceuticals Ltd.

Qingdao Baheal Medical, Inc.

CHEPLAPHARM Arzneimittel GmbH

+ [3]

Drug Highest PhaseApproved

First Approval Date

United States (18 Nov 2004),

Non-Small Cell Lung Cancer

RegulationOrphan Drug (United States), Priority Review (China)

Structure/Sequence

Molecular FormulaC22H24ClN3O4

InChIKeyGTTBEUCJPZQMDZ-UHFFFAOYSA-N

CAS Registry183319-69-9

922

Clinical Trials associated with Erlotinib Hydrochloride

NCT06545695

/ Not yet recruitingPhase 1/2IIT

Epidermal Growth Factor Receptor Inhibition for Keratinopathies

Epidermal growth factor receptor (EGFR) signaling plays a key role in regulating epidermal cell proliferation, survival, and differentiation. Keratins form a scaffold with epidermal desmosomes that involves ErbB/ EGFR signaling and keratin deficiency makes keratinocytes more sensitive to EGFR activation. Erlotinib, an EGFR inhibitor, was approved 20 years ago for cancer treatment and is generally used at 150 mg daily in adults >50 kg. While gastrointestinal and cutaneous side effects commonly occur at doses of 150 mg, adverse events occur less often at lower doses. We first reported erlotinib as effective for Olmsted syndrome, a rare hereditary EDD with painful PPK that results from variants in TRPV3. Erlotinib is now the treatment of choice for children and adults with Olmsted syndrome. Erlotinib is thought to inhibit formation of a complex that includes TRPV3, EGFR, and its primary skin-based ligand, TGF-a, which in turn regulates keratinocyte proliferation and differentiation. High-throughput screening to identify compounds that stabilize keratin filaments have also pointed to the EGFR pathway for targeting. Reviews and recent case reports have suggested the benefit of erlotinib for PC,
Given these preliminary data, we hypothesize that EGFR activation is a characteristic feature of keratinopathies. Further, we expect that oral low-dose erlotinib will improve the scaling and skin thickening of the spectrum of keratinopathies and be tolerated by most patients. For those who experience pain, particularly from plantar involvement, we predict that erlotinib therapy will improve mobility and pain. Finally, we aim to find the mechanism by which erlotinib improves the phenotypes of the various keratinopathies to better understand these disorders and predict response. We will look specifically at the impact on differentiation vs. hyperproliferation and barrier function, as well as the immune modulatory effects of the erlotinib using a multi-omics approach.

Start Date01 Dec 2026

Sponsor / Collaborator

Northwestern University

[+1]

NCT04172779

/ Not yet recruitingPhase 2IIT

Phase II Clinical Trial of Low-dose Erlotinib for Hepatocellular Carcinoma Chemoprevention

This phase II randomized placebo-controlled trial studies low-dose erlotinib treatment to assess its efficacy and safety to prevent development of hepatocellular carcinoma in patients with advanced liver fibrosis or cirrhosis.

Start Date01 Feb 2026

Sponsor / Collaborator

The University of Texas Southwestern Medical Center

[+1]

NCT06161558

/ WithdrawnPhase 1IIT

Phase 1 Umbrella Trial of Erlotinib In Combination With Select Tyrosine Kinase Inhibitors In Adult Patients With Advanced Solid Tumors

Cancers that return or spread after their first line of treatment are often difficult to treat with limited next step options. Based on preclinical studies, the EGFR-targeting tyrosine kinase inhibitor (TKI) Erlotinib may be better in stopping or slowing the growth of tumors when given in combination with the multitargeting TKI Lenvatinib or Axitinib. Participants will be screened with a physical exam and tests including urine and blood tests, imaging scans, and a test of their heart function. Erlotinib, axitinib, and lenvatinib are all capsules taken by mouth. All participants will take their drugs at home every day. Some participants will take erlotinib plus lenvatinib once a day. Some participants will take erlotinib once a day and axitinib twice a day. Assignment to one of the treatment arms will be determined by the study. Participants will record their doses in a diary. Treatment is given in 28-day cycles. All participants will have 4 clinic visits during their first treatment cycle. After that, they will have a clinic visit at the start of each new cycle. Imaging scans, blood and urine tests, and other tests will be repeated during various clinic visits. Participants will remain in the study for as long as the treatment is helping them. They will have follow-up phone calls after they stop treatment....

Start Date15 Jul 2025

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Erlotinib Hydrochloride

100 Translational Medicine associated with Erlotinib Hydrochloride

100 Patents (Medical) associated with Erlotinib Hydrochloride

10,695

Literatures (Medical) associated with Erlotinib Hydrochloride

01 Jan 2026·CURRENT MEDICINAL CHEMISTRY

An Innovative Telomere-associated Prognosis Model in AML: Predicting Immune Infiltration and Treatment Responsiveness

Article

Author: Sun, Jian ; Song, Binyang ; Lu, Xiao ; Mu, Lijun ; Tang, Bo ; Lou, Jinzhan

Aims::

To build an innovative telomere-associated scoring model to predict prognosis and treatment responsiveness in acute myeloid leukemia (AML).

Background::

AML is a highly heterogeneous malignant hematologic disorder with a poor prognosis. While telomere maintenance is frequently observed in tumors, investigations into telomere-related genes (TRGs) in AML remain limited.

Objectives::

This study aimed to identify prognostic TRGs using the least absolute shrinkage and selection operator (LASSO) Cox regression and multivariate Cox regression, evaluate their predictive value, explore the association between TRG scores and immune cell infiltration, and assess the sensitivity of high-scoring AML patients to chemotherapeutic agents.

Methods::

Univariate Cox regression analysis was conducted on the TCGA cohort to identify prognostic TRGs and to develop the TRG scoring model using LASSO-Cox and multivariate Cox regression. Validation was performed on the GSE37642 cohort. Immune cell infiltration patterns were assessed through computational analysis, and the sensitivity to chemotherapeutic agents was evaluated.

Results::

Thirteen prognostic TRGs were identified, and a seven-TRG scoring model (including NOP10, OBFC1, PINX1, RPA2, SMG5, MAPKAPK5, and SMN1) was developed. Higher TRG scores were associated with a poorer prognosis, as confirmed in the GSE37642 cohort, and remained an independent prognostic factor even after adjusting for other clinical characteristics. The high-score group was characterized by elevated infiltration of B cells, T helper cells, natural killer cells, tumor-infiltrating lymphocytes, regulatory T (Treg) cells, M2 macrophages, neutrophils, and monocytes, along with reduced infiltration of gamma delta T cells, CD4- T cells, and resting mast cells. Moreover, high infiltration of M2 macrophages and Tregs was associated with poor overall survival compared to low infiltration. Notably, high-risk AML patients were resistant to Erlotinib, Parthenolide, and Nutlin-3a, but sensitive to AC220, Midostaurin, and Tipifarnib. Additionally, using RT-qPCR, we observed significantly higher expression of two model genes, OBFC1 and SMN1, in AML tissues compared to control tissues.

Conclusion::

This innovative TRG scoring model demonstrates considerable predictive value for AML patient prognosis, offering valuable insights for optimizing treatment strategies and personalized medicine approaches. The identified TRGs and associated scoring models could aid in risk stratification and guide tailored therapeutic interventions in AML patients.

01 Feb 2026·ANTI-CANCER DRUGS

Successful treatment with erlotinib plus ramucirumab in a patient with non-small-cell lung cancer harboring EGFR exon 20 insertion mutation

Article

Author: Yamaoka, Koji ; Umeda, Yukihiro ; Waseda, Yuko ; Nakashima, Koki

As epidermal growth factor receptor ( EGFR ) exon 20 insertion mutations generally result in poor sensitivity to EGFR -tyrosine kinase inhibitors (TKIs), the administration of EGFR -TKIs is not recommended in non-small-cell lung cancer (NSCLC). Nonetheless, EGFR exon 20 A763_Y763insFQEA, a genotype of EGFR exon 20 insertion mutations, has some sensitivity to EGFR -TKIs. However, the therapeutic effects of EGFR -TKIs alone for EGFR exon 20 A763_Y763insFQEA are insufficient compared to those for common EGFR mutations. Therefore, more effective treatment options are required for this mutation. Herein, we present a case in which treatment with erlotinib plus ramucirumab led to a complete response and progression-free survival of 13 months in a 79-year-old man with advanced NSCLC harboring EGFR exon 20 A763_Y763insFQEA. This case suggests that this regimen should be considered as an effective treatment option for such patients.

01 Jan 2026·BIOCHEMICAL PHARMACOLOGY

Exosomal transfer of VPS9D1-AS1 induces M2 polarization to promote erlotinib resistance of LUAD cells via activation of the Wnt/β-catenin signaling pathway

Article

Author: Teng, Zhuoran ; Hou, Yu ; Lu, Fei ; Gao, Yanping ; Jv, Yunhe ; Zhang, Qiao ; Gao, Jingyan ; Wang, Miao ; Xia, Yaoxiong ; Li, Lan ; Li, Chen

Tumor microenvironment (TME) is widely recognized as a critical effector in lung adenocarcinoma (LUAD) progression. Tumor-associated macrophages (TAMs) are the main components of TME. A substantial amount of evidence has revealed the correlation between TAMs and the survival of LUAD patients. In this study, we firstly proved that long non-coding RNA (lncRNA) VPS9 domain containing 1 antisense RNA 1 (VPS9D1-AS1) regulates erlotinib resistance in LUAD. The focus of this study is to investigate whether exosome-transmitted VPS9D1-AS1 influenced erlotinib resistance in LUAD through interacting with TAMs. Our study found that VPS9D1-AS1 could induce M2 macrophages polarization. Besides, we proved that exosomal transfer of VPS9D1-AS1 promoted M2 polarization. Moreover, exosomal transfer of VPS9D1-AS1 induce Wnt/β-catenin pathway activation by recruiting MYCN opposite strand (NCYM) to promote glycogen synthase kinase-3β (GSK-3β) ubiquitination and degradation. Meanwhile, exosomal transfer of VPS9D1-AS1 sequestered miR-532-3p to up-regulate catenin beta 1 (CTNNB1). Taken together, exosomal transfer of VPS9D1-AS1 induced M2 polarization to promote erlotinib resistance of LUAD cells through activating Wnt/β-catenin pathway.

163

News (Medical) associated with Erlotinib Hydrochloride

18 Dec 2025

·signalchemlifesciences.com

SignalChem Lifesciences Corp. today announced the publication of first-in-human Phase 1 clinical trial results for SLC-391, its novel, orally bioavailable and selective AXL inhibitor, in the peer-reviewed journal Pharmaceuticals.

The article, titled “First-in-Human Phase I Clinical Trial of SLC-391, a Novel and Selective AXL Inhibitor, in Patients with Advanced Solid Tumours,” reports data from a multicentre, open-label Phase 1 dose-escalation study (NCT03990454) evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of SLC-391 in patients with heavily pretreated advanced solid tumours. Key findings from the study include: Favourable safety and tolerability profile: SLC-391 was generally well tolerated across evaluated once-daily (QD) and twice-daily (BID) dose levels. The maximum tolerated dose (MTD) was not reached. A total daily dose of 300 mg (150 mg BID) was identified as well tolerated, with no dose-limiting toxicities (DLTs) or serious adverse events (SAEs) observed at this dose. Manageable adverse events: The majority of treatment-emergent adverse events were Grade 1–2 and primarily gastrointestinal in nature, including nausea, fatigue, diarrhoea, and vomiting. Grade 3 treatment-related adverse events occurred in a limited number of patients and were manageable with dose modification or supportive care. Predictable pharmacokinetics supporting oral dosing: SLC-391 was rapidly absorbed, with a median time to maximum plasma concentration (Tmax) of approximately 2 hours. Plasma exposure increased in a generally dose-proportional manner, with steady-state concentrations achieved by Day 21. BID dosing reduced peak-to-trough variability and provided more consistent systemic exposure. Encouraging preliminary clinical activity: Twelve of 35 patients (34.3%) achieved stable disease with durations lasting up to 318 days on SLC-391 monotherapy. Clinical benefit was observed across multiple tumour types, including non-small cell lung cancer (NSCLC) and mesothelioma, in a heavily pretreated population. “These Phase 1 results demonstrate that SLC-391 has a promising safety profile and meaningful signs of clinical activity in patients with advanced solid tumours,” said Dr. Zaihui Zhang, corresponding author and CSO and VP R & D at SignalChem Lifesciences Corp. “The durability of stable disease observed in several patients supports the rationale for advancing SLC-391 into combination studies.” Based on these findings, SLC-391 has been evaluated in a Phase 1b/2a clinical trial in combination with pembrolizumab in patients with advanced or metastatic non-small cell lung cancer (NCT05860296). About SLC-391 SLC-391 is a next-generation, small-molecule, selective AXL kinase inhibitor designed to block AXL-mediated signalling pathways involved in tumour growth, metastasis, immune evasion, and resistance to anticancer therapies. About SignalChem Lifesciences Corp. SignalChem Lifesciences Corp. is a research-driven biotechnology company focused on the discovery and development of targeted kinase inhibitors for cancer and immune-mediated diseases. For more information, please visit https://www.signalchemlifesciences.com. Forward-Looking Statements and Information This release contains forward-looking statements that are not based on historical facts. These forward-looking statements involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied. Readers are cautioned not to place undue reliance on such forward-looking statements. Contact Zaihui Zhang, PhD CSO, VP R & D SignalChem Lifesciences Corp. 778-717-5433 x:114 The Novel Discovery by The University of British Columbia and SignalChem Lifesciences Corporation Has Been Published by the Prestigious Journal “Blood” Key points： · AXL activity is upregulated in acute myeloid leukemia (AML) stem/progenitor cells. · A novel AXL inhibitor SLC-391 is developed with favorable pharmaceutical properties. · AXL inhibition sensitizes AML cells to venetoclax, with strong synergistic effects via AXL/BCL-2-mediated OXPHOS/signaling pathways. VANCOUVER, BRITISH COLUMBIA – March 31, 2021 – SignalChem Lifesciences Corporation (“SLC”) is pleased to announce that a paper entitled “Targeting AXL Kinase Uniquely Sensitizes Therapy-Insensitive Leukemic Stem and Progenitor Cells to Venetoclax Treatment in Acute Myeloid Leukemia” has been published as First Edition by the journal “Blood” today. The research work described in this paper is the collaboration between University of British Columbia and SLC and it was supported by MITACS Accelerate program. In this study, we demonstrated that a key GAS6/AXL axis is highly activated in AML patient cells, particularly in stem/progenitor cells. We developed a potent, selective AXL inhibitor that has favorable pharmaceutical properties and efficacy against preclinical patient-derived xenotransplantation (PDX) models of AML. Importantly, inhibition of AXL sensitized AML stem/progenitor cells to venetoclax treatment, with strong synergistic effects in vitro and in PDX models. Mechanistically, single-cell RNA-sequencing and functional validation studies uncovered that AXL inhibition or in combination with venetoclax potentially targets intrinsic metabolic vulnerabilities of AML stem/progenitor cells, which shows a distinct transcriptomic profile and inhibits mitochondrial oxidative phosphorylation. Inhibition of AXL or BCL-2 also differentially targets key signaling proteins to synergize in leukemic cell killing. These findings have direct translational impact on the treatment of AML and other cancers with high AXL activity. “This new study has uncovered that AXL, one of key cancer drivers, is abnormally activated in blood cancer cells from AML patients, a difficult disease to treat. In this study we found that both genetic inhibition of AXL and the use of a highly selective AXL inhibitor SLC-391, in combination with a BCL-2 inhibitor (venetoclax) preferentially eliminate AML blast cells from drug-insensitive patients both in vitro and in preclinical PDX models, while not being toxic to healthy bone marrow cells. This new combination treatment approach may lead to more effective disease eradication, especially in patients at high risk of drug resistance and disease progression. Encouragingly, SLC-391 is currently being evaluated in a Phase I clinical trial in solid tumors, which opens a promising avenue for combination cancer therapies,” commented by Professor Xiaoyan Jiang in the Department of Medical Genetics of the University of British Columbia and Distinguished Scientist at BC Cancer, the senior author and the principal investigator of this paper. “We are very pleased with the recognition of this discovery by Professor Jiang’s lab in collaboration with SLC. We are going to pursue the clinical research in combination therapy of SLC-391 with a putative BCL-2 inhibitor in this AML patient population and hope that it will provide another valuable therapy to fight against this terrible disease,” said Mr. Jun Yan, President of SLC, “We have been working very hard to develop new anti-tumour therapies which provide superior advantages over the existing treatments.” SLC-391 is clinical stage small molecule AXL inhibitor with good potency and selectivity with desirable pharmaceutical properties. It has good selectivity against other tyrosine kinases. The pharmacokinetic studies in rodents and dogs indicated that SLC-391 has high bioavailability with a simple suspension formulation (>50%). The in vivo studies demonstrated efficacy in different animal models including NSCLC, CML and AML models. Moreover, it has exhibited a strong synergistic effect in tumour growth inhibition in combination with erlotinib and paclitaxel in NSCLC xenograft models and demonstrated a strong synergistic effect in decreasing leukemia burden and enhancing survival of leukemic animals in a novel combination approach with BCL-2 inhibitor venetoclax in aggressive xenotransplant AML leukemic models and PDX models. In a CT-26 colon cancer syngeneic model, SLC-391 played a role in modulating both the innate and adaptive immune responses and demonstrated a synergistic effect in tumour growth inhibition and overall survival in combination with an anti-PD-1 antibody. In addition, SLC-391 promotes anti-tumour immunity through modulation of tumour-associated macrophage polarization. Currently, SLC-391 is under phase I safety clinical evaluations in multi-cancer centres in Canada and the dose expansion phase is anticipated to be complete by Q3/2021. About SignalChem SignalChem Lifesciences Corporation (“SLC”) is a multi-platform, clinical-stage, drug discovery and development company focusing on development of next generation of novel, small molecule kinase inhibitors as targeted therapy for the treatment of cancer. SLC has a strong small-molecule drug development pipeline. SLC is seeking strategic partners to aid in bringing our clinical-stage drug pipeline to the market. SignalChem Biotech Inc. (https://www.signalchem.com), a separate division from SignalChem Lifesciences, is a biotech company focused on the research, development and production of innovative and high-quality human recombinant cell signaling products. Throughout the years, SignalChem has capitalized on its core expertise in cellular signaling, molecular biology and protein biochemistry to generate more than 3,000 functional protein products. SignalChem strives to support scientists in academia, pharma and biotech companies around the world by creating effective research tools to advance the basic research in life sciences and to facilitate the efforts in drug discovery and development. For more information, please visit https://www.signalchemlifesciences.com. Forward-Looking Statements and Information This release contains forward-looking statements that are not based on historical facts. These forward-looking statements involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied. Readers are cautioned not to place undue reliance on such forward-looking statements. Contact Zaihui Zhang, PhD CSO, VP R&D SignalChem Lifesciences Corp. + 604 232 4600 ext. 114

Phase 1Clinical Result

17 Dec 2025

·www.globenewswire.com

Sol-Gel Provides Update Following Unblinding of Phase 1b Study of SGT-210 in Darier Disease

NESS ZIONA, Israel, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with rare and severe skin conditions, today provided an update following the unblinding of clinical data from its vehicle-controlled proof-of-concept Phase 1b study of SGT-210 on Darier disease. Following unblinding, the data from the vehicle-controlled Phase 1b proof-of-concept study did not show differentiation between SGT-210 and vehicle on the study’s efficacy assessments. Mr. Mori Arkin, Executive Chairman of Sol-Gel, stated: "After unblinding the clinical data from our trial, the study did not demonstrate a signal of superiority of active treatment versus vehicle, and we have therefore decided not to advance to the next stage of development in this indication. We intend to pursue very small, low-cost feasibility studies in other areas of unmet medical need where the mechanistic rationale for SGT-210 is strong. We continue to prioritize the successful completion of our Phase 3 program of SGT-610 in Gorlin syndrome and preparatory activities supporting a potential Phase 3 program in high-frequency BCC, subject to successful completion of the Gorlin Phase 3 trial." About Gorlin Syndrome and SGT-610 SGT-610, a hedgehog signaling pathway blocker, has the potential to be the first ever treatment for prevention of BCCs in Gorlin syndrome patients, if approved. Gorlin syndrome, an autosomal dominant genetic disorder affecting approximately 1 in 27,000-31,000 people in the U.S., is mostly caused by inheritance of one defective copy of the tumor suppressor patched homolog 1 (PTCH1) gene. Normally, the PTCH1 gene blocks the smoothened, frizzle class receptor (SMO) gene, turning off the hedgehog signaling pathway when it is not needed. Mutations in the PTCH1 gene may cause a loss of PTCH1 function, release of SMO, and may allow BCC tumor cells to divide uncontrollably. Patidegib, the active substance in SGT-610, is designed to block the SMO signal, thus, allowing cells to function normally and reducing the production of new tumors. About Sol-Gel Technologies Sol-Gel Technologies Ltd. is a dermatology company focused on identifying, developing and commercializing or partnering drug products to treat skin diseases. Sol-Gel developed TWYNEO which is approved by the FDA for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and EPSOLAY, which is approved by the FDA for the treatment of inflammatory lesions of rosacea in adults. The Company’s pipeline also includes Phase 3 clinical trial of Orphan and breakthrough drug candidate SGT-610, which is a new topical hedgehog inhibitor being developed to prevent the new basal cell carcinoma lesions in patients with Gorlin syndrome that is expected to have an improved safety profile compared to oral hedgehog inhibitors as well as topical drug candidate SGT-210 under investigation for the treatment of rare hyper keratinization disorders. For additional information, please visit our new website: www.sol-gel.com Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to statements regarding the successful completion of Phase 3 program of SGT-610 in Gorlin syndrome and a potential Phase 3 program in high-frequency BCC. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management’s current expectations and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to, the risk that we will not successfully complete the Gorlin Phase 3 trial or that it will be delayed, that we will not commence a potential Phase 3 program in high-frequency BCC, and if we do that it will not be successful, the risk that the market for SGT-610 and SGT-210 will not be as anticipated, including with respect to High-Frequency BCC for SGT-610, our ability to enter into further collaborations, a delay in the timing of our clinical trials, top-line results and regulatory filings, the success of our clinical trials, and an increase in our anticipated costs and expenses, as well as the following factors: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets, the potential delay in receiving such regulatory approvals and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our collaborators’ ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our collaborators’ ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our collaborators’ ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, China, Europe or Israel; and (xv) loss or retirement of key executives and research scientists; (xvi) general market, political and economic conditions in the countries in which the Company operates; and, (xvii) the current war between Israel and Hamas and any deterioration of the war in Israel into a broader regional conflict involving Israel with other parties. These factors and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 13, 2024, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Except as required by law, we undertake no obligation to update any forward-looking statements in this press release. Sol-Gel Contact:Eyal Ben-Or Chief Financial Officerinfo@sol-gel.com+972-8-9313429 Source: Sol-Gel Technologies Ltd.

Phase 1Phase 3Drug ApprovalClinical Result

16 Dec 2025

·pmlive.com

Researchers at University of Geneva develop test platform for cancer treatments

Researchers at the University of Geneva (UNIGE) have developed in vitro models of the kidneys, liver and heart for the purposes of testing the effects of new cancer treatments on healthy tissue. Acquired resistance, when tumours develop resistance to cancer treatments, represents a major challenge in oncology. While combination therapies have shown great promise in overcoming that resistance, they are often highly toxic to healthy organs and tissues. The UNIGE team’s new laboratory platform allows for the rapid testing of drug effects without the need for animal models. Patrycja Nowak-Sliwinska, associate professor in the School of Pharmaceutical Sciences at the UNIGE Faculty of Science, said: “This platform models the human kidney, heart and liver in vitro, as clusters of cells derived from human tissue. “[It enables us to] study how new drug combinations interact with these organs and then decide whether it is justified to move on to in vivo testing in humans or animals.” The research, published in Biomedicine and Pharmacotherapy, focused on the kidneys, liver and heart – three organs that are particularly sensitive to combination therapies. Scientists from the School of Pharmaceutical Sciences, in collaboration with the UNIGE Faculty of Medicine and Geneva University Hospital (HUG), tested two drug combinations currently in development, C2 (erlotinib HCl, dasatinib, tubacin, tacedinaline) and REMP (erlotinib HCl, parthenolide, metformin HCl, RAPTA-C). In one notable finding, they discovered that C2 demonstrated significant liver toxicity, showing that in vivo testing may not be appropriate for this combination. Another advantage of this new approach is that it takes only two weeks to obtain results, whereas animal models take around ten weeks or more. The researchers noted: “In addition to saving a significant amount of time, this approach is fully in line with the 3R principle, which aims to ‘reduce’, ‘replace’ and ‘refine’ the use of animal models in research.” The next step in the research will be to extend the model to other treatment-sensitive organs. The researchers hope to one day move beyond standard cell lines and instead use patient-derived cells, allowing drug combinations to be tested for toxicity in a personalised context.

100 Deals associated with Erlotinib Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D04023	Erlotinib Hydrochloride	L01XE03	DB00530

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
EGFR positive non-small cell lung cancer	Japan	CHEPLAPHARM Arzneimittel GmbH	14 Jun 2013
EGFR positive non-small cell lung cancer	Japan	Chugai Pharmaceutical Co., Ltd.	14 Jun 2013
Pancreatic Cancer	European Union	CHEPLAPHARM Arzneimittel GmbH	19 Sep 2005
Pancreatic Cancer	Iceland	CHEPLAPHARM Arzneimittel GmbH	19 Sep 2005
Pancreatic Cancer	Liechtenstein	CHEPLAPHARM Arzneimittel GmbH	19 Sep 2005
Pancreatic Cancer	Norway	CHEPLAPHARM Arzneimittel GmbH	19 Sep 2005
Non-Small Cell Lung Cancer	United States	OSI Pharmaceuticals, Inc.	18 Nov 2004

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	Phase 3	United States	Eli Lilly & Co.	06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	Phase 3	Japan	Eli Lilly & Co.	06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	Phase 3	Canada	Eli Lilly & Co.	06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	Phase 3	France	Eli Lilly & Co.	06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	Phase 3	Germany	Eli Lilly & Co.	06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	Phase 3	Greece	Eli Lilly & Co.	06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	Phase 3	Hong Kong	Eli Lilly & Co.	06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	Phase 3	Italy	Eli Lilly & Co.	06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	Phase 3	Romania	Eli Lilly & Co.	06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	Phase 3	South Korea	Eli Lilly & Co.	06 May 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CS-Lung006 (ESMO_ASIA2025)	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR mutations	43	Erlotinib and Ramucirumab (exon 19 deletions)	fmkclmpgpl(vcphoebuox) = pvsybxhsyd rivzqcailb (iprfqclwfs, 0.4 - NA) View more	Positive	05 Dec 2025
				Erlotinib and Ramucirumab (L858R)	fmkclmpgpl(vcphoebuox) = wotklqfevy rivzqcailb (iprfqclwfs, 2.5 - 6.7) View more
ESMO_ASIA2025	Not Applicable	Locally Advanced Head and Neck Squamous Cell Carcinoma Neoadjuvant	124	Taxane-platinum doublet chemotherapy with triple oral metronomic chemotherapy & low dose nivolumab	rhwoxfocsn(prkjaepbvs) = mobksucbam pwxkdnnuoc (flfflgioxj ) View more	Positive	05 Dec 2025
ESMO_ASIA2025	Not Applicable	Squamous Cell Carcinoma of Head and Neck \| Non-Small Cell Lung Cancer \| Gastrointestinal Neoplasms	48	Low-dose nivolumab + metronomic chemotherapy	cqipbqzsti(qfmwdwivcd) = Low-dose nivolumab combined with triple metronomic chemotherapy with Erlotinib, Methotrexate and Celecoxib, demonstrated a favorable safety profile, with predominantly grade 1-2 adverse events tlkmndmhbd (vbbwekzjyh )	Positive	05 Dec 2025
NCT01927744 (CTgov)	Phase 2	Squamous Cell Carcinoma of Head and Neck	55	Phone Call+Erlotinib+Docetaxel (Chemotherapy + Erlotinib)	zramjtnglb = tkccnvvcng bidifkpezt (lqvwvjktkc, txnczgkutc - bysbyqcmcl) View more	-	26 Nov 2025
				Phone Call+Docetaxel (Chemotherapy + Placebo)	zramjtnglb = gxxchafztm bidifkpezt (lqvwvjktkc, idozrwxzii - henwedvizp) View more
ESMO2025	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR mutations	174	Erlotinib+beta-blocker	uxswpzcxgn(plltmedxov) = xfkonmabvp cdlnivmija (jywbmztyqt, 14.8 - 50.0) View more	Positive	17 Oct 2025
				Erlotinib	uxswpzcxgn(plltmedxov) = vdhflvtrqq cdlnivmija (jywbmztyqt, 14.8 - 25.0) View more
ASCO2025	Not Applicable	Advanced Head and Neck Squamous Cell Carcinoma	97	Dual Oral Metronomic Therapy (OMT)	dptywjpost(txxeeahbpe) = deosefybyn xegoeekopz (vxbbvpwdwm ) View more	Positive	30 May 2025
				Triple Oral Metronomic Therapy (OMT)	dptywjpost(txxeeahbpe) = eadlqzxhvz xegoeekopz (vxbbvpwdwm ) View more
NCT00448240 (CTgov)	Phase 2/3	Advanced Head and Neck Squamous Cell Carcinoma	6	Erlotinib	gkctefijsn = trrvpbunul uiirepxadw (jsnydaspsy, lraakrtmry - wnknerfjqv) View more	-	18 Mar 2025
NCT03137771 (NRG-LU002, CTgov)	Phase 2	metastatic non-small cell lung cancer \| Recurrent Non-Small Cell Lung Cancer	218	Erlotinib Hydrochloride+Gemcitabine+Docetaxel+Pembrolizumab+Pemetrexed Disodium (Arm 1 (systemic maintenance chemotherapy))	byxsidttlg(zxzlbxoqym) = vlwhzezhjl ksmcztceuj (mkomfpohnq, zkyymeoqyp - uerclhfexd) View more	-	11 Mar 2025
				Stereotactic Body Radiation Therapy (SBRT)+Erlotinib Hydrochloride+Gemcitabine+Docetaxel+Pembrolizumab+Pemetrexed Disodium (Arm 2 (LCT + systemic maintenance chemotherapy))	byxsidttlg(zxzlbxoqym) = ykwkzbxyzu ksmcztceuj (mkomfpohnq, pyjklazhjs - aacymcyztd) View more
NCT00446225 (EURTAC, CTgov)	Phase 3	Advanced Lung Non-Small Cell Carcinoma	174	Erlotinib (A: Erlotinib Group)	qefkvczcuy(bhhcjxoqmr) = toqqdqjhxw kocldesmfe (tiqkxizoza, waqkqdqawe - omvstvkgmy) View more	-	05 Mar 2025
				Carboplatin+gemcitabine+Docetaxel+Cisplatin (B: Standard Chemotherapy Group)	qefkvczcuy(bhhcjxoqmr) = vlzaiwdhvb kocldesmfe (tiqkxizoza, mkvboqikde - seadezfkfb) View more
NCT01887795 (ENTER, Pubmed \| Transl Lung Cancer Res)	Phase 3	Brain metastases epidermal growth factor receptor (EGFR)-mutant	-	Whole-brain radiotherapy (WBRT)	jrjmktbxgb(vbadoqjmgl) = urgerysmhg ldkoampaip (daunbikcaf ) View more	Positive	01 Dec 2024
				WBRT + Erlotinib	jrjmktbxgb(vbadoqjmgl) = rawedqkmag ldkoampaip (daunbikcaf ) View more

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