Clinical study of sintilimab combined with albumin-bound paclitaxel, gemcitabine and thymalfasin in the preoperative treatment of borderline resectable pancreatic cancer/locally advanced pancreatic cancer

Start Date15 Jul 2025

Sponsor / Collaborator

The First Affiliated Hospital of Soochow University

100 Clinical Results associated with Thymalfasin

100 Translational Medicine associated with Thymalfasin

100 Patents (Medical) associated with Thymalfasin

1,174

Literatures (Medical) associated with Thymalfasin

31 Dec 2025·DRUG DELIVERY

Exploiting the potential of in situ forming liquid crystals: development and in vitro performance of long-acting depots for peptide drug thymosin alpha 1 subcutaneous administration

Article

Author: Matjaž, Mirjam Gosenca ; Zvonar Pobirk, Alenka ; Roškar, Robert ; Vitek, Mercedes

The fast-growing filed of long-acting depots for subcutaneous (SC) administration holds significant potential to enhance patient adherence to treatment regimens, particularly in the context of chronic diseases. Among them, injectable in situ forming lyotropic liquid crystals (LCCs) consisting of hexagonal mesophases represent an attractive platform due to their remarkable highly ordered microstructure enabling the sustained drug release. These systems are especially relevant for peptide drugs, as their use is limited by their short plasma half-life and inherent poor stability. In this study, we thus aimed to exploit the potential of a liquid crystalline platform for the sustained release of peptide drug thymosin alpha 1 (Tα1), characterized by a short plasma half-life and with that associated twice-weekly SC administration regimen. We initially selected specified ingredients, with ethanol serving to reduce viscosity and stabilize the peptide drug Tα1, lecithin contributing to LCCs formation and stabilization, and glycerol monooleate or glycerol monolinoleate representing the hexagonal LCCs forming matrix material. The selected studied nonaqueous precursor formulations were characterized by suitable rheological properties for SC injection. A convenient and rapid in situ phase transition of precursor formulations to hexagonal LCCs, triggered by water absorption, was successfully accomplished in vitro. Notably, in situ formed LCCs demonstrated sustained release kinetics of the peptide drug Tα1 for up to 2 weeks of in vitro release testing, offering minimized dosing frequency and thus promoting patient adherence. In summary, the newly developed in situ forming liquid crystalline systems represent prospective injectable long-acting depots for SC administration of the peptide drug Tα1.

25 Sep 2025·BRITISH JOURNAL OF HOSPITAL MEDICINE

Thymosin α1 Combined With 2HRZE/4HR Regimen as a Potential Treatment of Pulmonary Tuberculosis: An Analysis of Immune Function, Pulmonary Function and Inflammatory Response

Article

Author: Sun, Xuelian ; Wu, Guofeng

Aims/Background Immunotherapy plays a critical role in the clinical treatment of tuberculosis, an infectious disease caused by Mycobacterium tuberculosis, in which immune damage promotes the occurrence and development of the disease. This study aimed to investigate the efficacy of thymosin α1 combined with the 2HRZE/4HR (2 months of isoniazid, rifampin, pyrazinamide, and ethambutol followed by 4 months of isoniazid and rifampin) in the treatment of pulmonary tuberculosis and its effect on immune function and inflammatory factors. Methods A retrospective analysis was conducted on 106 pulmonary tuberculosis patients treated between October 2022 and June 2024. The patients were divided into two groups based on their treatment regimens: the control group (n = 47) received the 2HRZE/4HR treatment, while the observation group (n = 59) received thymosin α1 in addition to the 2HRZE/4HR treatment. All patients underwent a 6-month treatment course. Clinical efficacy was evaluated 6 months after treatment based on clinical symptoms and sputum smear results. The study compared foci resorption rates, cavity closure rates, and changes in pulmonary function indices, immune function indices, and inflammatory factor levels before and after treatment between the two groups. Adverse reactions were also recorded and analyzed. Results The total effective rate and the rate of foci resorption and cavity closure of the observation group were higher than the control group (p < 0.05). After 6 months of treatment, forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC, and peak expiratory flow (PEF) of the observation group were higher compared to the control group (p < 0.05). Compared with the control group, the observation group exhibited lower mRNA expression of T-cell immunoglobulin mucin-1 (TIM-1) and TIM-3; reduced levels of immunoglobulin E (IgE), sputum supernatant, serum interleukin-4 (IL-4) and tumor necrosis factor-alpha (TNF-α); but higher interferon-gamma (IFN-γ) levels (p < 0.05). There was no significant difference in the incidence of adverse reactions between the two groups (p > 0.05). Conclusion Thymosin α1 combined with the 2HRZE/4HR regimen holds promise as an effective treatment of pulmonary tuberculosis by improving immune function and pulmonary function of patients while attenuating the inflammatory response.

01 Aug 2025·iScience

Interferon-α and thymosin-α1 plus tislelizumab enhance CD8+ T cell cytotoxicity toward pancreatic ductal adenocarcinoma

Article

Author: Tan, Wenzhi ; Wang, Jinfeng ; Deng, Rilin ; Xu, Biaoming ; Peng, Mingjing ; Hu, Qi ; Zuo, Chaohui ; Zhu, Haizhen ; Deng, Shun ; Zheng, Jinhai

The strong immunosuppression and immune evasion of pancreatic ductal adenocarcinoma (PDAC) result in poor efficacy of immune checkpoint blockade. In this study, the PD-1 level on CD8⁺ T cells in the peripheral blood of patients with PDAC was significantly greater than that in the peripheral blood of healthy individuals. To enhance the anticancer activity of adoptive CD8⁺ T cells toward PDAC, interferon-α (IFN-α) and thymosin-α1 (Tα1) plus tislelizumab were preclinically explored. Compared with those of tislelizumab monotherapy, the proliferation and cytokine secretion of CD8⁺ T cells and the cytotoxic activity toward PDAC cells were significantly greater with the combination treatment of IFN-α and Tα1 plus tislelizumab. Moreover, the growth of PDAC tumors was inhibited by CD8⁺ T cells with high efficacy under the combination treatment. Thus, IFN-α and Tα1 plus tislelizumab enhance the anticancer activity of CD8⁺ T cells toward PDAC, representing an alternative strategy for improving cancer immunotherapy.

News (Medical) associated with Thymalfasin

29 Mar 2024

·www.pharmaceutical-technology.com

Gilead’s Vemlidy expands label to treat paediatric chronic HBV

Vemlidy is approved to treat patients six years and older for chronic HBV. Credits: Sundry Photography/Shutterstock.com Soon after GSK gained traction with a US Food and Drug Administration (FDA) fast track designation for its investigational treatment bepirovirsen for chronic hepatitis B virus (HBV), Gilead Sciences has strengthened its position in the indication with an FDA approval for Vemlidy (tenofovir alafenamide) to treat paediatric patients. The once daily 25mg tablets have been greenlit to treat patients with chronic HBV with compensated liver disease that are six years and older and weigh at least 25kg. The supplemental new drug application (sNDA) approval was based on data from the ongoing Phase II Study 1092 (NCT02932150), comparing the safety and efficacy of 25mg Vemlidy to placebo in 88 treatment-naïve and treatment-experienced patients with chronic HBV. As per a 28 March press release, patients treated with Vemlidy and those that switched to open-label Vemlidy after week 24 demonstrated “progressive increases in rates of virological suppression” by week 96. “The expanded indication for Vemlidy for the treatment of children as young as six years old is a testament to the safety, tolerability and efficacy profile of this therapy,” said Dr. Frank Duff, Gilead’s senior vice president of the virology therapeutic area, in the announcement. The pharma giant aims to continue addressing unmet treatment needs for children, he added. Vemlidy, a small molecule nucleoside analogue reverse transcriptase inhibitor, was first FDA approved in 2016 as a treatment for adults with chronic HBV and gained its first label expansion in 2022 to treat patients aged 12 years and older with compensated liver disease. The product is marketed with a boxed warning for post-treatment severe acute exacerbation of hepatitis B. See Also: Angelini gets grant for method for labelling reels using robot and application roller Rohto Pharmaceutical gets grant for ophthalmic composition for treating myopia with crocetin and ginkgo leaf GlobalData’s drugs database forecasts that the hepatitis B treatment market will significantly increase over the next six years to reach $10.5bn in 2029, with analysts predicting a compound annual growth rate of 30%. According to the analysts, 71% of the sales in 2022 were attributed to Vemlidy and SciClone Pharmaceuticals’ Zadaxin, a synthetic polypeptide, indicating market dominance. GlobalData’s consensus forecasts predict that Vemlidy will generate $873m in sales in 2024. GlobalData is the parent company of Pharmaceutical Technology .

Drug ApprovalClinical ResultPhase 2Fast Track

27 Feb 2024

·www.businesswire.com

Sepsis Drug Pipeline Research Report 2024: Insights from 30 Companies and 35 Pipeline Drugs - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Sepsis - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 30+ companies and 35+ pipeline drugs in Sepsis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Sepsis pipeline landscape is provided which includes the disease overview and Sepsis treatment guidelines. The assessment part of the report embraces, in depth Sepsis commercial assessment and clinical assessment of the pipeline products under development In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Sepsis collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Sepsis R&D. The therapies under development are focused on novel approaches to treat/improve Sepsis. Sepsis Emerging Drugs Chapters This segment of the Sepsis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Sepsis Emerging Drugs Thymosin alpha 1: SciClone Pharmaceuticals Thymosin alpha 1, referred to as thymalfasin, is a synthetic 28-amino acid peptide with multiple biological activities primarily directed towards immune response enhancement. SciClone developed and launched Thymosin alpha 1, under the trade name Zadaxin, for the treatment of hepatitis B virus (HBV) infection and hepatitis C virus (HCV) infections. The drug is also being developed for the treatment of COVID 2019 infections. Scientific and clinical studies have shown that Thymosin alpha 1 helps to stimulate and direct the body's immune response to eradicate infectious diseases, such as HBV, HCV, bacterial, and fungal infections; to fight certain cancers such as melanoma and liver cancer; and to enhance response to vaccines. Clinical trials have shown that Thymosin alpha 1 improves survival in patients in intensive care units being treated for sepsis from severe bacterial infections. The therapy is being evaluated in Phase III stage to treat Sepsis. Currently, the drug is in Phase III stage of its development for the treatment of sepsis. Enibarcimab: AdrenoMed AG Enibarcimab (HAM8101; former name: Adrecizumab) a clinical-stage, first-in-class drug targeting loss of vascular integrity. The strong rationale for Enibarcimab is supported by the elegance of its mode of action, a monoclonal antibody that on binding to its target Adrenomedullin preserves its functionality as regulator of vascular integrity. Enibarcimab targets Adrenomedullin (ADM), a vasoprotective peptide hormone. ADM that remains in the bloodstream, however, has a different effect, one that helps mitigate sepsis: promoting stability of the endothelial barrier by restoring the cell junctions between endothelial cells that ordinarily regulate molecule transport and leakage. In health, levels of ADM in the bloodstream and extravascular space are in equilibrium so that endothelial barrier integrity is maintained and blood pressure remains normal. Currently, the drug is in Phase II stage of its development for the treatment of sepsis. M 6229: Matisse Pharmaceuticals Matisse's platform technology is based on the discovery that in many patients suffering from sepsis, proteins called histones are released by the innate immune system and dying cells into the blood stream, where they are toxic to other cells. Due to a self-enforcing cascade, people may die from organ failure within one or two days. Preclinical results have shown that by neutralizing the toxic histones with Matisse's product M6229, the negative cascade is terminated by neutralization of cationic histones by anionic M6229. Matisse claims to have identified an elegant solution for treating one of the major complications in sepsis by using a non-anticoagulant fraction of heparin called M6229 to neutralize toxic circulatory histones .Currently, the drug is in Phase I stage of its development for the treatment of sepsis. SNIPR 001: SNIPR Biome SNIPR001 is a novel, orally-administered antibiotic that is designed to precisely target difficult-to-treat bacterial infections. It is developed using SNIPR Biome's CRISPR-Guided VectorsT (CGVT Technology), which is designed to deliver CRISPR reagents into target bacterial cells. SNIPR001 is designed to target certain E. coli bacteria in the gut and thus prevent their translocation to the bloodstream, without affecting beneficial bacteria in the microbiome. It contains four CRISPR-armed phages that selectively target and eliminate E. coli strains that are resistant to fluoroquinolone, with demonstrated efficacy in animal disease models. Currently, the drug is in preclinical stage of its development for the treatment of sepsis. Sepsis: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Sepsis therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Sepsis drugs. Sepsis: Therapeutic Assessment Phases Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Sepsis Report Insights Sepsis Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Sepsis Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players SciClone Pharmaceuticals AdrenoMed AG Matisse Pharmaceuticals SNIPR Biome Tianjin Chase Sun Pharmaceutical Beijing Scitech-Mq Pharmaceuticals Recce Pharmaceuticals Inotrem Octapharma Shaperon Shionogi Pharmazz Seres Therapeutics Key Products Thymosin alpha 1 Enibarcimab M 6229 SNIPR 001 Kukoamine B ST-1830 RECCE 327 Nangibotide OctaplasLG HY209 Cefiderocol Centhaquine SER 155 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/ixi7k5 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Phase 2Phase 3Phase 1

08 Jun 2017

·www.biospace.com

Investment Group Just Paid $605 Million for This Bay Area Pharma

June 8, 2017 By Mark Terry , BioSpace.com Breaking News Staff SciClone Pharmaceuticals , located in Foster City, Calif., agreed to be acquired for $605 million by a consortium of buyers. The consortium is made up of GL Capital Management CP , Bank of China Group Investment , CDH Investments , Ascendent Capital Partners and Boying . SciClone is a specialty pharmaceutical company with significant commercial business in China. Its portfolio covers oncology, infectious diseases and cardiovascular disorders. Its lead product is Zadaxin (thymalfasin) for hepatitis B, hepatitis C and some cancers, and is approved in over 30 countries. The Buyer Consortium that is acquiring the company will buy all the outstanding shares of SciClone for $11.18 per share in cash. It will be funded by the consortium via a combination of equity financing and debt financing. The $605 million figure is a premium of about 11 percent over its stock price on June 7, and a premium of more than 16 percent over its 10-day volume-weighted average closing stock price. The bid was first announced in November 2016. “The Board has determined that a sale of the Company at this time is the best way to deliver meaningful value to SciClone’s stockholders,” said Jon Saxe , SciClone’s chairman of the board, in a statement. “While SciClone has executed well on its growth strategies to date, following continued review of its strategic alternatives, the Board has determined that the challenges of continuing to operate as an independent U.S.-based, publicly traded company in the complex, competitive and increasingly price-sensitive China pharmaceuticals market represents long-term risks to the Company’s ability to maintain a strong growth trajectory and to meet its financial objectives. This agreement enables SciClone stockholders to achieve substantial cash value and premium to the Company’s recent trading price in the near term and eliminates exposure to long-term risk and uncertainty.” On May 10, the company reported its first-quarter financial results . It announced first-quarter revenues of $42.9 million, an 18 percent increase from $36.5 million from the same period the year before. First period Zadaxin revenues were $39.5 million, up 17 percent from $33.6 million in the first quarter of 2016. “We delivered a strong first quarter performance, in line with our expectations, and reflecting the continued demand for, and growth potential of, Zadaxin and our core business,” said Friedhelm Blobel , SciClone’s chief executive officer, in a statement. “Zadaxin’s competitive position remains strong, with continued volume growth despite generic competition. Zadaxin’s double-digit volume growth rate continued this quarter, underscoring its strength as the leading branded thymalfasin, with a 17 percent volume share and more than a 40 percent value share. We do face continued pricing pressure, with tenders in two provinces recently announced at prices lower than the reference price with our distributor. We cannot determine at this time with certainty when these prices will take effect, or when they will impact prices in other provinces, but we are likely to experience some effect of those lower prices at some point during the next few quarters. We may also see some pressure on unit volumes in some areas as a result of reduced national-level reimbursement for thymalfasins.” SciClone Pharmaceuticals is currently trading for $10.90.

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100 Deals associated with Thymalfasin

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Indication	Country/Location	Organization	Date
Hepatitis B, Chronic	China	Sciclone Pharmaceuticals Italy Srl	01 Jan 1996
Hepatitis C	-	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Sepsis with acute organ dysfunction	Phase 3	China	SciClone Pharmaceuticals (Holdings) Ltd.	06 Sep 2016
Shock, Septic	Phase 3	China	SciClone Pharmaceuticals (Holdings) Ltd.	06 Sep 2016
Hepatitis C, Chronic	Phase 3	United States	SciClone Pharmaceuticals (Holdings) Ltd.	01 Apr 2002
Hepatitis C, Chronic	Phase 3	Puerto Rico	SciClone Pharmaceuticals (Holdings) Ltd.	01 Apr 2002
Advanced Malignant Solid Neoplasm	Phase 2	China	SciClone Pharmaceuticals (Holdings) Ltd.	01 Apr 2023
EGFR positive non-small cell lung cancer	Phase 2	Italy	SciClone Pharmaceuticals (Holdings) Ltd.	01 Oct 2016
Influenza, Human	Phase 2	Italy	-	01 Nov 2009
Kidney Failure, Chronic	Phase 2	Italy	-	01 Nov 2009
Unresectable Hepatocellular Carcinoma	Phase 2	United States	SciClone Pharmaceuticals (Holdings) Ltd.	30 Apr 2004
Hepatocellular Carcinoma	Phase 2	United States	SciClone Pharmaceuticals LLC	28 Apr 2004

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Phase II study (ASCO2025)	Phase 2	Locally Advanced Melanoma	9	Thymosin α1 + Toripalimab	zuqezpaclu(bvftuxykrp) = lvpiifzuaw ssaggkrqjg (fwjiwijnsm ) View more	Positive	30 May 2025
NCT05790447 (PRaG regimen, ASCO2025)	Phase 2	Advanced Malignant Solid Neoplasm T lymphocyte counts \| Tregs	21	Thymosin Alpha 1 (Tα-1)	wbcojcysod(pzfclczyii) = ypwjmtudxl aqljyauydu (dmjapitzlu ) View more	Positive	30 May 2025
NCT06056804 (ASCO2025)	Phase 2	Mismatch repair-deficient Rectal Cancer Neoadjuvant MSS \| pMMR	25	Neoadjuvant chemoradiotherapy + Thymalfasin + Tislelizumab	ycqzzostao(dassrkmxsi) = observed in 15(75.0%) patients ejlxpwmrjl (yzodrdzoam ) View more	Positive	30 May 2025
NCT02867267 (TESTS, Pubmed \| BMJ)	Phase 3	Sepsis	1,106	Thymosin α1	ohkxneohap(fykvgrzpnl) = vzorvbciwk hfwsotvyzz (cyjyiawhun )	Negative	15 Jan 2025
				Placebo	ohkxneohap(fykvgrzpnl) = kmkpupowum hfwsotvyzz (cyjyiawhun )
NCT05790447 (PRaG 5.0 Study, ASTRO2024)	Phase 2	Metastatic Solid Tumor T lymphocyte count	6	PRaG regimen + Thymalfasin	wfjdipqevj(czowxkqaku) = sxawojprag wquauaigjs (drvnwdefie ) View more	Positive	01 Oct 2024
NCT04963712 (Pubmed \| BMC Infect Dis) Manual	Early Phase 1	HIV Infections PD-1 \| TIM-3 \| sjTREC	20	Thymosin α1 1.6 mg	byywqjxmyg(epkhrbwkxb) = cbaqyglsap wztljplflm (yxcpgzcfme ) View more	Positive	17 Jan 2024
				Thymosin α1ral therapy	byywqjxmyg(epkhrbwkxb) = ljagipviwq wztljplflm (yxcpgzcfme ) View more
ASCO2023	Not Applicable	-	-	Thymosin α1+consolidative immunotherapy	htghkfunen(kidxrqtvde) = fenangwmyh lvvxcsfndn (gvgrzhdhvw ) View more	Positive	31 May 2023
				Thymosin α1+CCRT	htghkfunen(kidxrqtvde) = cgwsshjjxn lvvxcsfndn (gvgrzhdhvw ) View more
ASCO2023	Not Applicable	Solid tumor	27	Thymosin α1	edpokcuwbx(ecjjbacmej) = hsjmqbebbi dsfvffujjj (osniqovwqw, 6.6 - 27.2)	Positive	31 May 2023
NCT04487444 (Pubmed \| J Infect Dis)	Phase 2	COVID-19	49	Thymalfasin (Tα1)	jccnglbrvm(hriaccnqkj) = Nine serious adverse events among treated patients were deemed not related to Tα1. cazudrrlip (qvjkeqmvtj ) View more	Positive	03 Sep 2022
				Thymalfasin (Tα1) (Standard of care)
Pubmed	Phase 2	Radiation Pneumonitis \| Locally Advanced Lung Non-Small Cell Carcinoma	69	Thymosin α1 + CCRT	nzmgkrgqrl(paibveizoq) = fqucgusqvg qfphvblrzp (bsuayizwop ) View more	Positive	20 Jul 2022
				CCRT alone	jqpyybznqm(duadzaohpa) = fodkvzqqgm qdxvbbilqu (wapjaxqfdf ) View more

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