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Last update 13 Aug 2025

Erlotinib Hydrochloride

Last update 13 Aug 2025

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 x EGFR L858R x EGFR-Ex19del

Action

antagonists, inhibitors

Mechanism

EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), 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+ [20]

Inactive Indication

Acute Myeloid LeukemiaAcute Myelomonocytic LeukemiaAcute Promyelocytic Leukemia+ [131]

Originator Organization

OSI Pharmaceuticals, Inc.

Pfizer Inc.

Active Organization

Eli Lilly & Co.

Genentech, Inc.

The University of Texas MD Anderson Cancer Center

+ [11]

Inactive Organization

OSI Pharmaceuticals, Inc.

Hoffmann-La Roche, Inc.Roche Pharma AG

+ [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

917

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 2025

Sponsor / Collaborator

Northwestern University

[+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

NCT06997068

/ RecruitingPhase 2IIT

Decentralized Pilot Study of Triple Oral Metronomic Chemotherapy for Patients With Recurrent/Metastatic Oral Cavity Cancer in a Rural Midwest United States Population

This phase II trial gathers information on the feasibility, safety, and effect of giving methotrexate, erlotinib, and celecoxib in treating oral cavity cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic) among rural Midwest patients. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid and may kill tumor cells. Erlotinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving the combination of methotrexate, erlotinib, and celecoxib may be feasible, safe, and effective in treating rural Midwest patients with recurrent/metastatic oral cavity cancer.

Start Date09 Jul 2025

Sponsor / Collaborator

Mayo Clinic

100 Clinical Results associated with Erlotinib Hydrochloride

100 Translational Medicine associated with Erlotinib Hydrochloride

100 Patents (Medical) associated with Erlotinib Hydrochloride

11,158

Literatures (Medical) associated with Erlotinib Hydrochloride

31 Dec 2025·ANNALS OF MEDICINE

A novel glycogene-related signature for prognostic prediction and immune microenvironment assessment in kidney renal clear cell carcinoma

Article

Author: Zhao, Danni ; Cui, Hanxiao ; Ren, Xueting ; Zhao, Xuyan ; Kang, Huafeng ; Liu, Peinan ; Li, Zihao ; Lin, Shuai ; Zhou, Mingjing

BACKGROUND:

Kidney Renal Clear Cell Carcinoma (KIRC) is a prevalent urinary malignancies worldwide. Glycosylation is a key post-translational modification that is essential in cancer progression. However, its relationship with prognosis, tumour microenvironment (TME), and treatment response in KIRC remains unclear.

METHOD:

Expression profiles and clinical data were retrieved from The Cancer Genome Atlas and Gene Expression Omnibus databases. Consensus clustering, Cox regression, and LASSO regression analyses were conducted to develop an optimal glycogene-related signature. The prognostic relevance of this molecular signature was rigorously analyzed, along with its connections to tumour microenvironment (TME), tumour mutation burden, immune checkpoint activity, cancer-immunity cycle regulation, immunomodulatory gene expression patterns, and therapeutic response profiles. Validation was performed using real-world clinical specimens, quantitative PCR (qPCR), and immunohistochemistry (IHC), supported by cohort analyses from the Human Protein Atlas (HPA) database.

RESULTS:

A glycogene-associated prognostic scoring system was established to categorize patients into risk-stratified subgroups. Patients in the high-risk cohort exhibited significantly poorer survival outcomes (p < 0.001). By incorporating clinicopathological variables into this framework, we established a predictive nomogram demonstrating strong calibration and a concordance index (C-index) of 0.78. The high-risk subgroup displayed elevated immune infiltration scores (p < 0.001), upregulated expression of immune checkpoint-related genes (p < 0.05), and an increased frequency of somatic mutations (p = 0.043). The risk score positively correlated with cancer-immunity cycle activation and immunotherapy-related signals. The high-risk groups also showed associations with T cell exhaustion, immune-activating genes, chemokines, and receptors. Drug sensitivity analysis revealed that low-risk patients were more sensitive to sorafenib, pazopanib, and erlotinib, whereas high-risk individuals responded better to temsirolimus (p < 0.01). qPCR and IHC analyses consistently revealed distinct expression patterns of MX2 and other key genes across the risk groups, further corroborated by the HPA findings.

CONCLUSION:

This glycogene-based signature provides a robust tool for predicting prognosis, TME characteristics, and therapeutic responses in KIRC, offering potential clinical utility in patient management.

31 Dec 2025·JOURNAL OF ENZYME INHIBITION AND MEDICINAL CHEMISTRY

Design, synthesis, and antiproliferative activity of new 5-ethylsulfonyl-indazole-3-carbohydrazides as dual EGFR/VEGFR-2 kinases inhibitors

Article

Author: Youssif, Bahaa G. M. ; Mahmoud, Mohamed A. ; Al-Wahaibi, Lamya H. ; Abou-Zied, Hesham A. ; Bräse, Stefan ; Rabea, Safwat M.

A novel series of 5-ethylsulfonyl-indazole-3-carbohydrazides 7a-o, serving as dual inhibitors of EGFR and VEGFR-2 was developed. The antiproliferative effects of compounds 7a-o were assessed against four cancer cell lines via the MTT assay. Compounds 7g, 7i-7l, and 7o emerged as the most efficient six derivatives, with GI₅₀ values ranging from 25 nM to 42 nM. Compounds 7j, 7k, and 7o (GI₅₀ values of 27, 25, and 30, respectively) demonstrated greater potency than erlotinib (GI₅₀ value of 33 nM), particularly against breast (MCF-7) cancer cell lines, and were identified as the most potent dual EGFR/VEGFR-2 inhibitors. Apoptotic markers assay results showed that increased levels of p53 and Bax proteins, along with lower levels of antiapoptotic Bcl-2, govern the apoptosis process in these new compounds. Computational analyses, encompassing molecular docking, molecular dynamics (MD) simulations, and density functional theory (DFT) computations, elucidated the binding interactions of these drugs with EGFR and VEGFR-2.

01 Nov 2025·BIOORGANIC & MEDICINAL CHEMISTRY LETTERS

Design, synthesis, and evaluation of 1,3,4-oxadiazole-based EGFR inhibitors

Article

Author: Xie, Yongmei ; Yuan, Mingqing ; Wang, Yijie ; Tang, Zijun ; Wen, Lin ; Hu, Mingxing ; Gan, Ye

The epidermal growth factor receptor (EGFR), a member of the receptor tyrosine kinase (RTK) family, serves as a validated and significant therapeutic target in various cancers. EGFR inhibitors have substantially improved the treatment outcomes for patients with EGFR-positive tumors. The EGFR^T790M mutation has emerged as a leading cause of clinically acquired resistance to both first- and second-generation EGFR inhibitors. In this study, we integrated azoles, particularly 1,3,4-oxadiazoles, into a preferred quinazoline scaffold to design novel EGFR inhibitors. Compound 4b, a new 1,3,4-oxadiazole-based EGFR inhibitor, demonstrated superior potency against the EGFR^L858R/T790M mutant (IC₅₀ = 17.18 nM compared to 733.20 nM for Erlotinib) and in NCI-H1975 cells (IC₅₀ = 2.17 ± 0.20 μM compared to 11.01 ± 0.05 μM for Erlotinib). Furthermore, 4b significantly inhibited the migration of both A431 and NCI-H1975 cells and induced G1 phase cell cycle arrest in NCI-H1975 cells. In conclusion, these findings suggest that 4b is a promising lead compound for the development of inhibitors targeting the EGFR^L858R/T790M mutation.

149

News (Medical) associated with Erlotinib Hydrochloride

24 Jun 2025

·www.prnewswire.com

Hoth Therapeutics HT-001 Interim Results First-in-Class Topical Therapy Preserves Cancer Treatment While Resolving Dermatologic Side Effects

Hoth Therapeutics' HT-001 Achieves 100% Response Rate in at least one endpoint in Phase 2a Trial in PK Patients for EGFR Inhibitor-Related Skin Toxicities. Hoth Therapeutics will host a Key Opinion Leader (KOL) event on, at 3:30PM EST to highlight recent clinical progress with HT-001, a novel topical therapeutic developed to address EGFR inhibitor-induced skin toxicities in cancer patients. This event will feature insights from derm-oncology and dermatology specialists Jonathan Hale Zippin M.D., Ph.D., and Adam Friedman M.D., F.A.A.D., who will present interim results from the ongoing Phase 2 trial and discuss how HT-001 could redefine supportive care standards for oncology patients. Access/join the event through the following link: . Phase 2a Trial Highlights (CLEER-001) 100% of enrolled patients in open-label cohort achieved at least one primary endpoint of clinical dermatologic improvement Over 65% reported reductions in pain and pruritus (itching) 0% required dose reduction or discontinuation of their EGFRI therapy. Topical therapy was well tolerated with no serious adverse events. NEW YORK, June 24, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing targeted therapies for rare and serious inflammatory conditions, today announced that its investigational candidate HT-001 met the primary efficacy endpoint in at least one metric in 100% of patients in its ongoing Phase 2a clinical study (CLEER-001) evaluating treatment for epidermal growth factor receptor inhibitor (EGFRI)-induced cutaneous toxicities. EGFR inhibitors, used widely to treat non-small cell lung cancer (NSCLC), pancreatic, breast, colorectal, and head and neck cancers, are associated with dermatologic side effects in up to 90% of patients, often resulting in painful rashes, pruritus, dryness, nail changes, and alopecia. These adverse events frequently force dose reductions or treatment discontinuation, limiting therapeutic efficacy and patient outcomes. "HT-001 is a breakthrough candidate with the potential to be the first FDA-approved therapy specifically targeting these EGFRI-related skin toxicities," said Robb Knie, CEO of Hoth Therapeutics. "The ability to preserve full-dose cancer treatment while improving patient quality of life addresses a critical unmet need across oncology." Phase 2a Trial Highlights (CLEER-001) 100% of enrolled patients in open-label cohort achieved at least one primary endpoint of clinical dermatologic improvement Over 65% reported reductions in pain and pruritus (itching) 0% required dose reduction or discontinuation of their EGFRI therapy. Topical therapy was well tolerated with no serious adverse events. HT-001 is a once-daily topical gel formulated with an FDA-approved neurokinin-1 receptor antagonist (NK1RA). This mechanism mitigates inflammatory pathways triggered by EGFR inhibition, particularly Substance P-driven responses that lead to skin breakdown. By targeting the neuroinflammatory axis, HT-001 reduces symptoms without immunosuppression or systemic toxicity. Supporting Preclinical Data In preclinical rat models co-treated with erlotinib (5.85 mg/kg/day), HT-001 significantly reduced: Dermatitis and alopecia severity Inflammatory markers including Substance P and neutrophil activity Disease progression even when HT-001 was introduced after symptom onset. Additionally, in compassionate-use human cases, complete symptom resolution was observed within one week, with no recurrence for up to three weeks post-treatment discontinuation. Regulatory and Development Pathway HT-001 is being advanced under the 505(b)(2) regulatory pathway, enabling the use of existing safety data to accelerate development. Key milestones include: IND opened and chronic toxicology completed. Phase 2a trial (CLEER-001) currently underway in the U.S. Phase 2b/3 trial planning in progress About Hoth Therapeutics Hoth Therapeutics, Inc. (NASDAQ: HOTH) is a biopharmaceutical company developing innovative therapies for patients with unmet medical needs. The Company's pipeline includes treatments targeting rare diseases, inflammatory skin disorders, cancer, and neurological conditions. For more information, visit: Forward-Looking Statement This press release includes forward-looking statements based upon Hoth's current expectations, which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties, and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, and the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; our intellectual property; our reliance on third-party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, and timing of product launches; management's expectation with respect to future acquisitions; statements regarding our goals, intentions, plans, and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms, or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section titled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance, or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events, or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. Investor Contact: LR Advisors LLC Email: [email protected] Phone: (678) 570-6791 SOURCE Hoth Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical Result

17 Jun 2025

·www.prnewswire.com

Lung Cancer Research Foundation Announces Request for Proposals Focused on Curing EGFR Mutant Lung Cancers

New Team Science Award is $1.5 million Over Three Years NEW YORK, June 17, 2025 /PRNewswire/ -- The Lung Cancer Research Foundation (LCRF) announces today a new funding mechanism: the 2025 LCRF Team Science Award on Advancing Therapies Toward Curing EGFR Mutated Lung Cancers. The Request for Proposals is now open for submissions. Designed to bring together scientific teams to accomplish innovative breakthroughs, this team science award must include at least two projects directed at understanding and treatment of resistant or persistent disease in EGFR mutated lung cancer. Lung cancer is responsible for more deaths worldwide than any other cancer, accounting for an estimated 124,730 deaths annually in the United States alone.1 In the last 10 to 15 years, accelerated clinical trials and FDA approvals of targeted therapies for non-small cell lung carcinoma have been possible in part due to advances in molecular profiling of tumors. Many of these targeted therapies are directed against oncogenic drivers. Epidermal growth factor receptor (EGFR) mutations were the first oncogenic drivers that were successfully targeted with the use of tyrosine kinase inhibitors (TKIs). Subsequently additional oncogenic driver alterations in EML4-ALK, BRAF, RET, KRAS G12C, HER2, MET, NTRK, ROS1 and NRG1 were identified along with corresponding therapeutic options for treatment. Several TKIs including gefitinib, erlotinib, afatinib, dacomitinib, and osimertinib have been approved by the FDA for the treatment of EGFR mutated (EGFRmut+) Non Small Cell Lung Cancer (NSCLC.) Despite substantial progress in the treatment of EGFRmut+ lung cancer, available treatments are not curative, and resistance invariably develops. Sometimes biopsies are repeated to identify the source of resistance to potentially evaluate patients for additional targeted therapy. Usually, at some point in time chemotherapy is employed to treat the disease. Immunotherapy in the form of PD-1/PD-L1 inhibitors has revolutionized the treatment of many forms of lung cancer but has not proven effective in the treatment of most oncogene-driven lung cancers. Given that therapeutic options available to date are not curative, there is a need for novel approaches to treat these lung cancers and improve outcomes for patients with the ultimate intention of cure. This grant mechanism will focus on furthering the development of novel therapies for patients with EGFRmut+ NSCLC. "There has been so much scientific discovery in EGFR mutated lung cancer, and with the development of targeted treatments, patients are living longer," said Benay Taub, lung cancer survivor. "However, even with the best of circumstances, resistance develops and we need patients to have more treatment options. The goal of this award is to support a team of committed researchers in pursuit of improved treatments and outcomes for lung cancer patients and hopefully, one day, a cure." "EGFR discoveries were the start of oncogene-driven treatment and while the science has made great strides, there is still a significant need for more to be discovered," says Dr. Antoinette Wozniak, Chief Scientific Officer for LCRF. "Our commitment to people affected by lung cancer is simple: continue to fund research that pushes the boundaries of what is known to what is possible – toward a cure. This award will hopefully move the science in that direction." "Tomorrow's breakthroughs are made possible by research that happens today," emphasized David Carbone, MD, PhD, Director, Translational Therapeutics Program, The Ohio State University Wexner Medical Center and member of LCRF's Scientific Advisory Board. "Taking a team approach to combatting resistance in EGFR mutant lung cancer promises to accelerate the pace of discovery." This new Team Science Award is made possible by a generous private donation from Benay and Steven Taub. Their visionary support reflects a deep belief in the power of collaboration to drive scientific discovery. Submissions to the Request for Proposals will be reviewed through a two-step process: Letters of Intent will be accepted until midnight on July 29, 2025; if selected, projects will then be chosen to submit full proposals. All applications will be subject to a rigorous review by LCRF's Scientific Advisory Board. More details about the Request for Proposal, along with eligibility, requirements, and deadlines can be found at LCRF.org/FundingOpportunities. Siegel RL, Giaquinto AM, Jemal A. CA: A Cancer Journal for Clinicians, Vol 24,Issue 1, Jan/Feb 2024 About the Lung Cancer Research Foundation (LCRF) The Lung Cancer Research Foundation® (LCRF) is the leading nonprofit organization focused on funding innovative, high-reward research with the potential to extend survival and improve quality of life for people with lung cancer. LCRF's mission is to improve lung cancer outcomes by funding research for the prevention, diagnosis, treatment, and cure of lung cancer. To date, LCRF has funded 429 research grants, totaling nearly $48 million, the highest amount provided by a nonprofit organization dedicated to funding lung cancer research. For more information about the LCRF grant program and funding opportunities, visit lcrf.org/research. Contact: LUNG CANCER RESEARCH FOUNDATION (LCRF) Sheila Sullivan Sr. Director, Marketing & Communications [email protected] SOURCE Lung Cancer Research Foundation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyClinical Study

23 May 2025

·www.globenewswire.com

Sol-Gel Reports First Quarter 2025 Results

NESS ZIONA, Israel, May 23, 2025 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company, today announced financial results for the first quarter ended March 31, 2025. Financial Results for the First Quarter Year Ended March 31st, 2025 Total revenue in the first quarter was $1 million compared to $0.5 million revenues for the same period in 2024. Research and development expenses were $8.8 million compared to $5.3 million in the same period in 2024. The increase of $3.5 million was primarily attributed to an increase of $3.6 million due to expenses associated with supplier-led manufacturing development to support future commercialization of SGT-610, an increase of $0.5 million related to the commercialization of EPSOLAY and TWYNEO in territories outside of the U.S., offset by a decrease of $0.5 million in clinical trial expenses related to SGT-610. General and administrative expenses were $1.3 million compared to $1.8 million for the same period in 2024. The decrease of $0.5 million was mainly attributed to a decrease in payroll and stock-based compensation expenses due to cost measures being taken in 2024. Sol-Gel reported a net loss of $8.8 million for the first quarter of 2025 and of $3.2 basic and diluted loss per share, compared to a net loss of $6.3 million and a loss of $2.3 per basic and diluted share for the same period in 2024. As of March 31, 2025, Sol-Gel had $16.9 million in cash, cash equivalents, and deposits and no marketable securities for a total balance of $16.9 million. The Company expects its cash resources to fund cash requirements into the first quarter of 2027. About Sol-Gel Technologies Sol-Gel Technologies, Ltd. is a dermatology company focused on identifying, developing and commercializing or partnering drug products for the treatment of 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 includes Orphan Drug candidate, SGT-610 under investigation for the prevention of new basal cell carcinomas in Gorlin syndrome patients, and also includes topical drug candidate SGT-210 under investigation for the treatment of rare skin keratodermas. For additional information, please visit 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 our expected cash runway. 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, our ability to enter into further collaborations, lower than anticipated annual revenue income from new collaborations, a delay in the timing of our clinical trials, 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 April 29, 2025, 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 TECHNOLOGIES LTD.CONDENSED CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands)(Unaudited) December 31, March 31, 2024 2025Assets CURRENT ASSETS: Cash and cash equivalents$19,489 $16,890 Bank deposits 12 12 Marketable securities 4,425 - Accounts receivables 3,595 3,883 Prepaid expenses and other current assets 3,774 2,647 TOTAL CURRENT ASSETS 31,295 23,432 NON-CURRENT ASSETS: Restricted long-term deposits and cash equivalents 1,291 1,293 Long-term receivables 1,024 518 Property and equipment, net 202 183 Operating lease right-of-use assets 1,426 1,332 Other long-term assets 13 - Funds in respect of employee rights upon retirement 595 305 TOTAL NON-CURRENT ASSETS 4,551 3,631 TOTAL ASSETS$35,846 $27,063 Liabilities and shareholders' equity CURRENT LIABILITIES: Accounts payable$1,265 $438 Other accounts payable 3,590 3,702 Current maturities of operating leases 430 433 TOTAL CURRENT LIABILITIES 5,285 4,573 LONG-TERM LIABILITIES: Operating leases liabilities 878 746 Liability for employee rights upon retirement 833 363 Other long-term Liability 1,209 TOTAL LONG-TERM LIABILITIES 1,711 2,318 TOTAL LIABILITIES 6,996 6,891 SHAREHOLDERS' EQUITY: Ordinary shares, NIS 0.1 par value – authorized: 5,000,000 as of December 31, 2024 and March 31, 2025, respectively; issued and outstanding: 2,785,762 as of December 31, 2024 and March 31, 2025, respectively (*) 774 774 Additional paid-in capital 258,959 259,089 Accumulated deficit (230,883) (239,691) TOTAL SHAREHOLDERS' EQUITY 28,850 20,172 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY$35,846 $27,063 (*) All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split. SOL-GEL TECHNOLOGIES LTD.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(U.S. dollars in thousands)(Unaudited) Three months endedMarch 31 2024 2025 LICENSE REVENUES$466 $1,031 RESEARCH AND DEVELOPMENT EXPENSES 5,345 8,843 GENERAL AND ADMINISTRATIVE EXPENSES 1,833 1,257 OPERATING LOSS 6,712 9,069 FINANCIAL INCOME,net (368) (261) LOSS FOR THE PERIOD 6,344 8,808 BASIC AND DILUTED LOSS PER ORDINARY SHARE 2.3 3.2 WEIGHTED AVERAGE NUMBER OF SHARES*OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE (*) 2,785,762 2,785,762 (*)All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split. Sol-Gel Contact:Eyal Ben-OrChief Financial Officerir@sol-gel.com+972-8-9313429Source: Sol-Gel Technologies Ltd.

Financial StatementDrug Approval

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.

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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

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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	Spain	Eli Lilly & Co.	06 May 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2025	Not Applicable	Advanced Head and Neck Squamous Cell Carcinoma	97	Dual Oral Metronomic Therapy (OMT)	dilftomelz(fmbaozasri) = hmxrfnccfq bxgkwlstep (tshfmjstze ) View more	Positive	30 May 2025
				Triple Oral Metronomic Therapy (OMT)	dilftomelz(fmbaozasri) = nvojrsemma bxgkwlstep (tshfmjstze ) View more
NCT00448240 (CTgov)	Phase 2/3	Advanced Head and Neck Squamous Cell Carcinoma	6	Erlotinib	wnpiuwzxmu = aeqwrlubci bgygcbbjzj (soehuqnqfg, wcppzoacog - jokqyjqtms) 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))	slvyznhljm(yanzbqurhy) = fpgqdpclbo tiumwlnisn (kukiaqczgk, qxzephvura - ijfidkvmqf) View more	-	11 Mar 2025
				Stereotactic Body Radiation Therapy (SBRT)+Erlotinib Hydrochloride+Gemcitabine+Docetaxel+Pembrolizumab+Pemetrexed Disodium (Arm 2 (LCT + Systemic Maintenance Chemotherapy))	slvyznhljm(yanzbqurhy) = dejxwmxvtu tiumwlnisn (kukiaqczgk, nqlcqsolgr - lwbihdzplh) View more
NCT00446225 (EURTAC, CTgov)	Phase 3	Advanced Lung Non-Small Cell Carcinoma	174	Erlotinib (A: Erlotinib Group)	ktnhjpictf(zpoyhatjge) = aheangtshu pjufjbazkg (tjyuudilak, hfgshrjzph - snppgbdbul) View more	-	05 Mar 2025
				Carboplatin+gemcitabine+Docetaxel+Cisplatin (B: Standard Chemotherapy Group)	ktnhjpictf(zpoyhatjge) = qzejpoxepn pjufjbazkg (tjyuudilak, sbirnbkcgt - jtcpfgkvyz) View more
NCT01887795 (ENTER, Pubmed \| Transl Lung Cancer Res)	Phase 3	Brain metastases epidermal growth factor receptor (EGFR)-mutant	-	Whole-brain radiotherapy (WBRT)	wvqeppxptg(luyshmkmli) = hdxdlgrsdu yzxcaxixtu (ysqflcfuml ) View more	Positive	01 Dec 2024
				WBRT + Erlotinib	wvqeppxptg(luyshmkmli) = ukcryhmwzz yzxcaxixtu (ysqflcfuml ) View more
NCT02411448 (RELAY, Pubmed \| J Thorac Oncol)	Phase 3	EGFR-mutated non-small Cell Lung Cancer EGFR exon 19del \| L858R mutation \| TP53 co-mutation ... View more	449	Erlotinib + Ramucirumab	fxjlldnsgr(sxnxstqicj) = lfplowsosx uedydsefhl (thnxwgbhsr ) View more	Negative	01 Nov 2024
				Placebo + Erlotinib	fxjlldnsgr(sxnxstqicj) = qqmguousjw uedydsefhl (thnxwgbhsr ) View more
CTRI/2020/03/023943 (BEER BTC, Pubmed \| J Clin Oncol)	Phase 2/3	Advanced Bile Duct Carcinoma Maintenance	98	Erlotinib (Active Surveillance)	ggumrkgjzd(vseegjuner) = 1 (2%) with erlotinib qgvkpbltsx (wcwryllpsi ) View more	Positive	20 Sep 2024
				Bevacizumab-Erlotinib
JPRN-UMIN000026197 \| JPRN-jRCTs031180404 (ESMO2024) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR Exon 19 Deletion \| EGFR L858R	25	Erlotinib	sruzvghqga(jbkzpvwwvn) = wmdegzghcd dopjtdsapj (fqdcbccspf, 6.6 - 30.8) Not Met View more	Negative	14 Sep 2024
				Erlotinib (EGFR exon 19 deletions)	sruzvghqga(jbkzpvwwvn) = fqjlohzdol dopjtdsapj (fqdcbccspf ) Not Met View more
WCLC2024 Manual	Not Applicable	metastatic non-small cell lung cancer EGFR Mutation	3	EGFR-TKIs + Thoracic Radiation Therapy	ojssvcqgbj(vprbiclsjj) = isziyaykyb xdvntivtyw (hkguhzyqau, 7 - 33) View more	Positive	08 Sep 2024
WCLC2024 Manual	Not Applicable	EGFR positive non-small cell lung cancer EGFR Mutation	32	Erlotinib	ufuyvesxvg(habbbssunt) = lomsyjbyhc csbyafvhsi (imczltzsgs ) View more	Positive	07 Sep 2024
				Erlotinib (exon 19 deletion + progress on EGFR TKIs)	kljhpauidb(sxsaopuxbt) = eesqdpynys xckhbvqofs (tvzlvuwdsl )

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