The present study will administer the drug leronlimab to 20 participants who are above 50 years old with Alzheimer's disease (AD) or mild cognitive impairment due to AD. While leronlimab is considered safe in other diseases like Human Immunodeficiency Virus (HIV) and certain types of breast cancer, its safety and tolerability in AD will be tested for the first time. The main purpose of this study is to learn:
1. Is this drug safe for participants with AD and MCI due to AD?
2. Does leronlimab change levels of brain inflammation?
The results of this study could lead to future studies with more participants that will test whether leronlimab may slow or prevent the decline in thinking abilities and brain function in this group of participants. Using leronlimab for Alzheimer's disease is experimental, which means that the Food and Drug Administration (FDA) has not approved Leronlimab for this purpose.
Participants will be asked to take leronlimab once a week for 12 weeks in our clinic or in their own home. Participants will also be asked to complete the below procedures before and after taking leronlimab for 12 weeks:
1. Undergo 2 types of brain scans, Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).
2. Visit our clinic for routine lab work, an electrocardiogram (ECG), and a physical exam.
3. Donate blood so the researchers can better understand how leronlimab affects levels of inflammation and proteins related AD in the blood.
4. Undergo a series of tests and questionnaires that test thinking abilities.
5. Have weekly phone calls with researchers to let them know if there are side effects will taking this drug.

Start Date30 Apr 2026

Sponsor / Collaborator

Weill Medical College of Cornell University

NCT06699836

/ Active, not recruitingPhase 2

A Phase Two Study Evaluating Two Doses of Leronlimab (PRO 140) In Combination With Trifluridine + Tipiracil (TAS-102) + Bevacizumab in Participants With Microsatellite Stable (MSS), Relapsed Refractory Metastatic Colorectal Cancer (mCRC)

This is an open label, randomized, two arm, multi-center study to explore the effect of leronlimab on the overall response rate/ overall survival and safety and tolerability when used in combination with trifluridine and tipiracil + bevacizumab in patients with MSS, mCRC who have progressed on prior treatment before participating in the study. The main questions this study aims to answer are:
1. Can leronlimab, in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab, increase the objective response rate in persons with MSS, mCRC who have progressed on prior treatment before participating in the study.
2. Is leronlimab safe and well tolerated in these subjects when used in combination with standard of care therapies trifluridine and tipiracil+ bevacizumab.

Start Date16 Jun 2025

Sponsor / Collaborator

CytoDyn, Inc.

[+1]

NCT05730673

/ WithdrawnPhase 2

A Phase II Study of Leronlimab (PRO 140) in Combination With Regorafenib in Patients With CCR5+, Microsatellite Stable (MSS), Metastatic Colorectal Cancer (mCRC)

This is aPhase II Study of Leronlimab (PRO 140) in combination with Regorafenib in Patients with CCR5+, Microsatellite Stable (MSS), Metastatic Colorectal Cancer (mCRC)

Start Date20 Sep 2022

Sponsor / Collaborator

CytoDyn, Inc.

[+1]

100 Clinical Results associated with Leronlimab

100 Translational Medicine associated with Leronlimab

100 Patents (Medical) associated with Leronlimab

Literatures (Medical) associated with Leronlimab

01 Jul 2026·LIFE SCIENCES

Omega-3 modulates macrophage immunometabolic profile without changing Pseudomonas aeruginosa proliferation

Article

Author: Corsetti, Patrícia Paiva ; Miranda, Tatiana Teixeira de ; de Araújo, Leonardo Pereira ; Moreira, Ana Clara ; Fagundes, Caio Tavares ; Braida, Yasmin Vieira ; Carneiro, Fernanda Silva ; Silva, Evandro Neves ; Sousa, Lirlândia Pires de ; de Almeida, Leonardo Augusto ; Sousa, Priscila Vilela

The increasing and often indiscriminate use of medications challenges populations with limited access to effective treatments. Natural compounds such as omega-3 fatty acids (FA), including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), exert immunomodulatory effects by incorporating into macrophage membranes and modulating cytokine production and metabolism. This study evaluated the effects of omega-3 FA on inflammatory responses, metabolic reprogramming, and signaling pathways in bone marrow-derived macrophages (BMDMs) infected with Pseudomonas aeruginosa. BMDMs from C57BL/6 mice were pretreated for 3 h with 26 mg DHA and 36 mg EPA, then stimulated with P. aeruginosa (PA14), heat-killed bacteria (HKPA), or lipopolysaccharide (LPS). Omega-3 FA pretreatment reduced pro-inflammatory mediators, including TNF-α, IL-1β, nitric oxide, and NLRP3 expression in macrophages stimulated with PA14, HKPA and LPS, while IL-10 secretion was also reduced under these stimuli. However, omega-3 FA increased IL-10 production under basal conditions. Gene expression analysis revealed upregulation of M2-associated markers (ARG1 and CD206), without changes in the M1 marker iNOS. Metabolic and transcriptional analyses demonstrated downregulation of glycolysis-related genes and upregulation of genes associated with mitochondrial function and lipid metabolism. Omega-3 FA did not alter P. aeruginosa proliferation but increased bacteria phagocytosis. Molecular docking suggested that omega-3 FA interact with key inflammatory targets, including GPR120 and PPARγ. Consistently, pharmacological antagonism of PPARγ reversed the omega-3 FA suppressive effects on TNF-α and IL-1β production and NLRP3 expression. These results indicate that omega-3 FA modulates macrophage immune responses and metabolism during P. aeruginosa infection, promoting an anti-inflammatory, metabolically adapted phenotype without impairing bacterial clearance.

01 Jul 2026·BIOCHIMIE

Effects of head group substitution on large antiviral polyamide-DNA binding kinetics

Article

Author: Fisher, Chris ; Koeller, Kevin J ; Song, Yang ; Niederschulte, Jacquelyn ; Edwards, Terri G ; Dupureur, Cynthia M ; Bashkin, James K ; Harris, G Davis

Hairpin polyamides are pyrrole-based polymers that bind in the minor groove of DNA with remarkable affinity and specificity. While the natural product netropsin that inspired PA design features a terminal guanidinium group, few studies have examined how the head groups affect PA-DNA binding behavior and biological activity. Here the effects of two headgroup substitutions on DNA binding and antiviral behavior are explored with two large (14- and 20-ring) hairpin polyamides. To complete two sets of three polyamides, the syntheses of two, 20-ring hairpin polyamides with N-terminal cationic substitutions (guanidinium (Guan) and tetramethyl guanidine (TMG)) are reported. Using a fluorescence binding assay, some small differences in binding affinity toward a small DNA hairpin are observed for the PA14 series, with head-group substitution weakening low-nM binding by at least several-fold. DNA binding kinetics for head group-substituted PA14 exhibit biphasic traces. The head groups have no effect on a diffusion-controlled binding event, but result in a newly observed, concentration-independent slower phase. In contrast, head group substitutions significantly weaken DNA binding for PA20, and in the case of PA20-Guan, by 1000-fold. Head group substitution results in a faster first binding event for PA20, and a newly detected, second, slower binding event. Head group substitutions do not significantly alter dissociation decay constants for the PA14 series, with little effect across the PA20 series. Perturbations in pM to low nM PA-DNA binding affinities have little to no impact on μM IC₅₀ and IC₉₀ values. However there is a positive correlation between long residence times and antiviral behavior.

29 Apr 2026·Science Translational Medicine

Adeno-associated virus gene therapy-mediated CCR5 blockade suppresses virus replication long term in SHIV-infected macaques.

Article

Author: Crank, Hugh ; Swanson, Tonya ; Hull, Joshua A ; Fuchs, Sebastian P ; Fisher, Hannah K ; Smedley, Jeremy V ; Pessoa, Cleiton T ; Desrosiers, Ronald C ; Bailey, Lauren ; Webb, Gabriela M ; Elmore, Zachary C ; Barber-Axthelm, Aaron ; Sacha, Jonah B ; Wu, Helen L ; Brown, Mischa K ; Chun, Kimberly ; Magnani, Diogo M ; Fennessey, Christine M ; Devlin, Garth ; Axthelm, Michael K ; Fischer, Miranda ; Potter, Sofia K ; Humkey, Matthew C ; Asokan, Aravind ; Hwang, Joseph M ; Boyle, Carla D ; Keele, Brandon F ; McCullen, Allyson J ; Waytashek, Courtney M ; White, Riely ; Kukula, Kaitlyn A ; Zikos, Joanna ; Armantrout, Kimberly

Adeno-associated virus (AAV) vectors are promising vehicles for the delivery and long-term expression of antibodies for treatment of chronic diseases. Given the strong link between the C-C chemokine receptor 5 (CCR5)-Δ32/Δ32 genotype and protection from HIV, we explored the ability of AAV vectors expressing the CCR5-blocking antibody leronlimab to mediate a functional cure in simian-human immunodeficiency virus (SHIV)-infected rhesus macaques by interrupting viral access to the viral entry co-receptor CCR5. Delivery of AAV-leronlimab to rhesus macaques elicited antidrug antibodies (ADA) and rapid plasma leronlimab clearance in approximately half of the treated macaques. However, in these same animals, we observed spontaneous leronlimab transgene reemergence and detectable CCR5 receptor occupancy approximately 1 year later that subsequently persisted indefinitely without rebound of ADA. In macaques that did not mount robust ADA responses, detectable plasma leronlimab concentrations and CCR5 receptor occupancy were maintained for more than 1 year. Of the nine macaques producing sufficient leronlimab to achieve full CCR5 receptor occupancy on blood CD4⁺ T cells, AAV-leronlimab drove stringent or partial control of SHIV viremia in six macaques long term. In the three macaques with uncontrolled SHIV viremia, short-term administration of exogenous leronlimab induced complete SHIV suppression in two and a 100-fold reduction in the third, indicating that a threshold of leronlimab expression is necessary to effectively halt SHIV replication. These results demonstrate the potential of gene therapy-mediated long-term antibody-based CCR5 blockade for HIV functional cure but highlight challenges in achieving sufficient antibody expression when targeting an abundant self-antigen.

172

News (Medical) associated with Leronlimab

15 May 2026

·www.biospace.com

CytoDyn to Present at the LD Micro Invitational XVI

CFO Robert E. Hoffman to deliver company presentation on May 18 at 10 a.m. PT VANCOUVER, Washington, May 15, 2026 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer (“mTNBC”) and colorectal cancer (“CRC”), today announced that CFO Robert E. Hoffman will present a corporate overview at the LD Micro Invitational XVI, taking place May 17-19, 2026, at the Luxe Sunset Boulevard Hotel in Los Angeles, CA. Presentation Date: Monday, May 18, 2026 Time: 10 a.m. PDT Link to view presentation: Webcast Link - LD Micro Invitational XVI . Mr. Hoffman will be available for one-on-one meetings with conference attendees. To request a meeting to discuss the Company’s current development strategy and upcoming milestones, please contact ir@cytodyn.com . About LD Micro LD Micro is dedicated to being the definitive resource in the small-cap space. From its industry-recognized index and robust data to hosting some of the most influential events each year, LD Micro’s mission is to provide unparalleled access and insight for those seeking the next generation of great companies. To learn more about LD Micro, visit . About CytoDyn CytoDyn is a clinical-stage oncology company dedicated to advancing leronlimab, a first-in-class humanized monoclonal antibody that targets the CCR5 receptor, a key regulator of immune function implicated in cancer, infectious diseases, and autoimmune disorders. Guided by a mission to improve patients’ quality of life through therapeutic innovation, CytoDyn is committed to integrity, responsibility, and service as it works to bring transformative treatments to patients worldwide. For more information, please visit and follow us on LinkedIn . Note Regarding Forward-Looking Statements This news release may contain forward-looking statements relating to, among other things, the mechanism of action of leronlimab, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except as required by applicable law. Corporate Contact CytoDyn Inc. ir@cytodyn.com Media Contacts David Schull or Ignacio Guerrero-Ros, Ph.D. Russo Partners, LLC CytoDyn@russopartnersllc.com

07 May 2026

·www.prnewswire.com

Physicians Committee Highlights Citizen Complaint Raising Questions About Research Integrity at OHSU

Complaint Calls for Review of Drug Company Ties to Monkey Research at OHSU PORTLAND, Ore., May 7, 2026 /PRNewswire/ -- The Physicians Committee for Responsible Medicine is calling attention to a citizen complaint filed with the Oregon Health & Science University (OHSU) Integrity Office that alleges concerning research practices involving OHSU, its primate experimentation center, and its relationship with a pharmaceutical company attempting to market an unproven drug. The complaint calls for an investigation into OHSU's association with CytoDyn and the investigational drug leronlimab, citing issues with research standards, financial relationships, and disclosure practices. The Physicians Committee for Responsible Medicine, a medical ethics nonprofit organization, is highlighting the complaint in light of its longstanding advocacy work to end primate experiments at OHSU. The organization has previously called for the Oregon National Primate Research Center (ONPRC) to stop experimenting on primates and shift instead to research methods that more reliably translate to human health outcomes and has supported a recent OHSU Board resolution to explore transitioning the ONPRC to a sanctuary model. "The primate center has been criticized for killing baby monkeys, dosing pregnant monkeys with alcohol and drugs, and failing to use better scientific methods," said Janine McCarthy, MPH, director of research policy at the Physicians Committee for Responsible Medicine. "This complaint raises a whole new set of concerns, related to questionable financial relationships." "The fact that the former CytoDyn CEO who was sentenced to prison for fraud is a co-author on a half-dozen research OHSU publications raises obvious questions," said Neal Barnard, MD, president of the Physicians Committee for Responsible Medicine. "Enough is enough." The complaint, filed by an Oregon resident on April 30, requests an investigation into OHSU's primate experiments using CytoDyn's investigational drug. Publicly available federal records indicate CytoDyn and its former leadership have faced legal actions related to misleading statements made to investors about the progress of developing a treatment for HIV. The Physicians Committee supports this request for a review of OHSU's past and ongoing relationship with CytoDyn, in the interest of transparency and research integrity. To speak with Dr. Barnard or Ms. McCarthy, please contact Reina Pohl at 202-527-7326 or [email protected]. Founded in 1985, the Physicians Committee for Responsible Medicine is a nonprofit organization that promotes preventive medicine, conducts clinical research, and encourages higher standards for ethics and effectiveness in research. SOURCE Physicians Committee for Responsible Medicine 21% more press release views with Request a Demo

Patent Infringement

05 May 2026

·www.prnewswire.com

Creatv Announces Five Clinical Data Presentations at ASCO 2026

MONMOUTH JUNCTION, N.J., May 5, 2026 /PRNewswire/ -- Creatv Bio, a Division of Creatv MicroTech, Inc. ("Creatv"), a cancer diagnostic blood testing company, is pleased to announce one poster presentation and four poster abstracts in conjunction with it's pharmaceutical company collaborators at the upcoming 2026 ASCO Annual Meeting, May 29-June 2, 2026, McCormick Place, Chicago, Illinois. Abstract Title: Monitoring blood-based biomarkers as early predictors of progression-free survival in a randomized Bria-ABC phase 3 trial for advanced metastatic breast cancer: An ongoing analysis. Abstract: 2652 Session Title: Developmental Therapeutics—Immunotherapy Poster Board: 442 Date and Time: May 30, 2026, 1:30 PM – 4:30 PM CDT Poster Abstracts in Collaboration with BriaCell, a clinical-stage immuno-oncology drug company, Abstract Title: Monitoring PD-L1 expression in circulating cancer associated cells for prediction of clinical outcomes in metastatic breast cancer patients treated with immune checkpoint inhibitors. Abstract: e14535 Abstract Title: Liquid biopsy to stratify metastatic breast cancer progression risk using multi-analyte cell subtyping prior to systemic therapy. Abstract: e15525 Poster Abstracts in Collaboration with CytoDyn, a biotechnology company developing innovative treatments for cancer. Abstract Title: Safety and 5-year survival following treatment with leronlimab plus physician's choice combination therapy in patients with metastatic triple-negative breast cancer. Abstract: e14535 Abstract Title: Leronlimab in combination with trifluridine/tipiracil (TAS-102) plus bevacizumab for patients with refractory metastatic colorectal cancer (mCRC): The phase 2 CLOVER study. Abstract: e13109 Creatv Bio's LifeTracDx® blood test, described in the abstracts above, was used in the various studies to rapidly develop companion/complementary diagnostic tools for specific cancer therapies and provided continuous monitoring of cancer patients for pharmaceutical companies to optimize therapy regimes. About Creatv Bio Creatv Bio is a CLIA-certified cancer diagnostics company providing laboratory testing services to pharmaceutical and research partners, as well as to patients for research and investigational purposes. The LifeTracDx® blood test is an analytically validated assay under ongoing research and development. Current research applications include evaluation of circulating biomarkers in oncology to support translational and exploratory studies. The assay is intended for research and investigational use only and is not intended for use in clinical diagnosis, prognosis, treatment selection, or disease monitoring. For our research studies and complete listing of peer-reviewed publications and scientific posters, please visit our website at creatvbio.com. Creatv contacts: SOURCE Creatv MicroTech, Inc. 21% more press release views with Request a Demo

ImmunotherapyPhase 3Phase 2Clinical Result

100 Deals associated with Leronlimab

External Link

KEGG	Wiki	ATC	Drug Bank
D11399	Leronlimab	-	DB05941

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	NDA/BLA	United States	CytoDyn, Inc.	01 Nov 2021
COVID-19	Phase 3	United States	CytoDyn, Inc.	05 Aug 2020
Alzheimer Disease	Phase 2	United States	Weill Medical College of Cornell University	30 Apr 2026
Encephalitis	Phase 2	United States	Weill Medical College of Cornell University	30 Apr 2026
Neuroinflammation	Phase 2	United States	Weill Medical College of Cornell University	30 Apr 2026
pMMR/MSS/MSI-L Colon Cancer	Phase 2	United States	CytoDyn, Inc.	16 Jun 2025
Unresectable Colorectal Carcinoma	Phase 2	United States	CytoDyn, Inc.	16 Jun 2025
Metastatic Colorectal Carcinoma	Phase 2	-	CytoDyn, Inc.	20 Sep 2022
Metastatic Microsatellite Stable Colorectal Carcinoma	Phase 2	-	CytoDyn, Inc.	20 Sep 2022
MSS/pMMR/MSI-L Colorectal Carcinoma	Phase 2	-	CytoDyn, Inc.	20 Sep 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02859961 (CTgov)	Phase 2/3	HIV Infections	562	PRO 140 (Part 1 - 350 mg Weekly Injections of PRO 140, Group A)	oznhuspryv = rijxjkxiqq zzdvnzlqgg (uwvubzoybt, usisdzlrmx - wcyhwebxer) View more	-	04 Mar 2026
				PRO 140 (Part 1 - 525 mg Weekly Injections of PRO 140, Group B)	oznhuspryv = clivdqvfbd zzdvnzlqgg (uwvubzoybt, uhcoskmdkj - vfejmzpxgt) View more
NCT04504942 (Phase 2 single-arm basket study, CTgov)	Phase 2	Metastatic Solid Tumor \| Solid tumor	16	Leronlimab	kwqofzozsr = utdcabuhwv hihiinhsag (odstycdzvd, ljvfcqmxhv - osqzeialws) View more	-	23 Jan 2026
NCT03838367 (SABCS2025)	Phase 1/2	Triple Negative Breast Cancer PD-L1 \| PD-1 \| CCR5	28	Leronlimab ± immune checkpoint inhibitors (ICI) + various chemotherapies	omhsncavcc(gxinrgnywz) = gddcukszjf emechvfhbp (gecasliksp ) View more	Positive	12 Dec 2025
NCT02990858 (CTgov)	Phase 2/3	HIV Infections	43	PRO 140 (leronlimab) (PRO 140)	wfrwgbzkpw(nuamdaoqkl) = skttcxgkmr vsnrghkyfq (guehmqmryl, 1.11) View more	-	12 Nov 2025
				PRO 140 (leronlimab) (PRO 140 350 mg)	pupwviyxby(wwzncmslpg) = swtaijbork ocvzvqiksz (ambudjbcin, rxgpqydtbg - ipnnpdqcym) View more
NCT05271370 (CTgov)	Phase 2/3	HIV Infections	56	PRO 140 350 (PRO 140 350 mg)	ruildmzaai = qjpmnacyvq uqgbqcopyu (xxtlebjaxz, jbcwawpkrx - asvgfcjqbk) View more	-	30 Oct 2025
				PRO 140 525 (PRO 140 525 mg)	ruildmzaai = ahhaervffg uqgbqcopyu (xxtlebjaxz, sjxypllszc - vtxyamieup) View more
NCT02355184 (CTgov)	Phase 2	HIV Infections	20	PRO 140	fwqbxphlvz(iwyppckhsq) = umuuakcyyk dpxdtlonsx (evryyesusr, 225.6) View more	-	07 Oct 2025
NCT03902522 (CTgov)	Phase 2/3	HIV Infections	6	PRO 140	bfbvhzgulk = ebyiypipbq hrbkxuujkg (npcfjipwzf, ybvjingtxy - mgkaqyvhmv) View more	-	16 Sep 2025
NCT03838367 (CTgov)	Phase 1/2	Triple Negative Breast Cancer	10	AUC 5 Carboplatin+leronlimab (Phase II- MTD to be Established for the Combination Treatment)	mivjlpaaje(hhpmhpqohw) = seqogfhmhs hqsggunafp (htiqgczxqh, cklrmiafar - oaxksgqpvf) View more	-	09 Sep 2025
				AUC 5 Carboplatin+350 mg leronlimab (Phase I-Cohort A: 350 mg PRO 140 SC Weekly + AUC 5 Carboplatin)	giicdggobh = ukhwzxgxun rvodxyjphx (knmpfbxzpz, xwpkfmajdi - drkaxdyuvt) View more
NCT04347239 (CTgov)	Phase 2	COVID-19	484	Placebo (Placebo)	vpzeidivxa = fvphzgclak uiythoikir (tjvmgvqedc, ltzhxpykie - opuanvomve) View more	-	27 Aug 2025
				Leronlimab (700mg) (700mg Leronlimab)	vpzeidivxa = twrcgbxtee uiythoikir (tjvmgvqedc, lprvipfjda - putqgedfwx) View more
NCT04504942 (Phase 2 single-arm basket study, ESMO_GI2025)	Phase 2	Metastatic Colorectal Carcinoma CCR5-positive tumors	5	Leronlimab	phuupfsige(udlzwajnjb) = Two patients had grade 1 AEs that were deemed treatment related (infusion-related reaction and nausea) zsfzilcmnx (zvprjpjvfu )	Positive	03 Jul 2025

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