The goal of the CHAPAS-5 clinical trial is to find out how well different HIV treatments work in children and young people (from 4 weeks up to under 15 years old) living with HIV, including those starting treatment for the first time and those whose current treatment is not working well.
The study aims to learn whether newer or different combinations of medicines can better control the virus, be safer, and be easier to take.
The main questions it aims to answer are:
* Can these treatments help children stay alive and keep their HIV virus at very low levels (viral load below 400) after 48 weeks?
* Which treatment options are most effective, safest, and easiest for children and their carers to use?
Researchers will compare different treatment groups to see if some medicines work better than others. Participants will be given one of several HIV treatment combinations (all already used in care), and these will be compared to see if they lead to:
* Better control of HIV
* Fewer side effects
* Improved quality of life
Participants will:
* Be randomly assigned (like flipping a coin by computer) to one suitable HIV treatment
* Take their HIV medication every day as prescribed
* Attend clinic visits over about 1-2 years
At these visits, they will:
* Have blood tests to check HIV levels and general health
* Have health check-ups (e.g. weight, symptoms, side effects)
* Answer simple questionnaires about:
* How easy the treatment is to take
* Mood, sleep, and wellbeing
* Quality of life
* Receive support to help them take their medication regularly
Some participants may also take part in optional extra studies (for example, to understand how the drugs work in the body).
Overall, this study aims to identify the best HIV treatments for children and young people, so future care can be more effective, safer, and easier to follow.

Start Date01 Nov 2026

Sponsor / Collaborator

University College London

[+7]

NCT06428045

/ RecruitingPhase 1IIT

Synergistic Treatment With Antiretrovirals and Laser Interstitial Thermal thErapy (STARLITE) for Unresectable High-Grade Gliomas: A Phase 1 Study

The purpose of this study is to determine whether newly diagnosed high-grade glioma(s) that cannot be removed surgically change as a result of the study treatment; and to identify and evaluate the potential side effects (good and bad) of the study treatment in patients with newly diagnosed high-grade glioma(s) that cannot be removed surgically.

Start Date15 Apr 2025

Sponsor / Collaborator

University of Miami

[+1]

CTRI/2025/04/083819

/ Not yet recruitingNot ApplicableIIT

A clinical study to evaluate the Skin Irritation Potential of Foam Tech UPBC and ABC (Dry Chemical Powder) on healthy human volunteers - NIL

Start Date02 Apr 2025

Sponsor / Collaborator-

100 Clinical Results associated with Abacavir Sulfate

100 Translational Medicine associated with Abacavir Sulfate

100 Patents (Medical) associated with Abacavir Sulfate

3,113

Literatures (Medical) associated with Abacavir Sulfate

01 Jan 2027·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Application of an intracellular LC-MS/MS assay for the determination of carbovir-triphosphate and remdesivir-triphosphate in peripheral blood mononuclear cells and dried blood spots

Article

Author: Bushman, Lane R ; Anderson, Peter L ; Brooks, Kristina M ; Coyle, Ryan P ; Ellison, Lucas A ; Johnson, Bethany M ; Roon, Laura E ; Schwab, Stefanie K

Intracellular concentrations of antiviral nucleos(t)ide analogs are associated with a variety of clinical outcomes and toxicities, underscoring the need for novel quantification methods for commonly used antivirals in cellular matrices. Here, we extend a previously validated intracellular LC-MS/MS method to carbovir-triphosphate (CBV-TP) and remdesivir-TP (RDV-TP), the active anabolites of abacavir (ABC) and remdesivir (RDV), respectively, in peripheral blood mononuclear cells (PBMC) and dried blood spots (DBS). CBV-TP and RDV-TP concentrations in DBS were quantified using two 7 mm punches of spotted, dried whole blood extracted in 50:50 methanol:water solution (lysed intracellular matrix). Lysed PBMC samples were prepared in a 70:30 methanol:water solution. Phosphorylated intracellular analyte fractions were isolated from the lysed matrix using strong anion‑exchange solid‑phase extraction (SPE), enzymatically dephosphorylated to the parent drug, then desalted/concentrated with reversed phase SPE and quantified utilizing stable isotope labeled internal standards by LC‑MS/MS methods adapted from prior validated assays. Accuracy was within ±15% difference from nominal and precision was ≤ 15% coefficient of variation for all validation assessments for both CBV-TP and RDV-TP. The validated quantifiable range for CBV-TP was 5-2000 fmol/sample and 0.1-100 pmol/sample for RDV-TP. The methods were successfully applied to clinical research PBMC and DBS samples with reproducible results. Both analytes demonstrated accuracy and precision across tested concentration ranges and matrices, meeting regulatory criteria outlined in current bioanalytical guidance. These methods support novel intracellular data for CBV-TP and RDV-TP in PBMC and DBS, which will facilitate wider use in antiviral pharmacology research.

31 Dec 2026·ANNALS OF MEDICINE

Efficacy and metabolic outcomes of switching from an INSTI-based triple-drug regimen to dolutegravir/lamivudine in treatment-experienced HIV-1-infected patients: a 48-week real-world study

Article

Author: Li, Qisui ; Zhang, Wei ; Yuan, Jing ; Deng, Changgang

BACKGROUND:

Real-world data on switching from INSTI-based triple therapy to DTG/3TC in the Chinese population are lacking.

METHODS:

This retrospective study included 214 treatment-experienced patients with HIV from Chongqing Public Health Medical Center (2021-2022) on an INSTI-based triple-drug regimen for ≥6 months who switched to DTG/3TC for >12 months. Patients with pre-existing metabolic diseases were excluded. Participants were categorized: INSTI+TAF-free (n = 100, prior TDF/AZT/ABC), INSTI+TAF (n = 56, prior BIC/FTC/TAF), and INSTI+TAF+COBI (n = 58, prior EVG/c/FTC/TAF). Virological, immunological, and metabolic parameters were assessed at weeks 24 and 48.

RESULTS:

The INSTI+TAF+COBI group was significantly older (p=0.000). Virological suppression rates (<50 copies/mL) were high at switch (93%, 85.7%, 91.4%). The INSTI+TAF+COBI group had lower eGFR and higher TG, TC, HDL, and LDL at baseline (p < 0.05). After switching, virological suppression remained high (≥90%) at weeks 24 and 48. CD4+ T-cell increases showed no significant intergroup differences. Metabolic changes differed: TC changes were 0.57 mmol/L (IQR: -0.19-0.91) in INSTI+TAF-free, -0.09 mmol/L (-0.47-0.71) in INSTI+TAF, and -0.25 mmol/L (-0.99-0.33) in INSTI+TAF+COBI. LDL changes were 0.23 mmol/L (-0.23-0.67), -0.15 mmol/L (-0.39-0.01), and -0.18 mmol/L (-0.71-0.10), respectively. TC and LDL changes differed significantly among groups (p < 0.05).

CONCLUSION:

Switching to DTG/3TC maintained virological suppression and stable immunological outcomes. Patients previously on TAF-containing regimens demonstrated greater metabolic benefits than those on TAF-free regimens, possibly related to baseline TDF effects, requiring further confirmation.

31 Dec 2026·ASN Neuro

Exposure to Frontline Antiretroviral Dolutegravir Disrupts Oligodendrocyte Development Across Differentiation Stages

Article

Author: Cruz-Berríos, Melanie ; Grinspan, Judith B. ; Putatunda, Raj ; Romer, Micah A. ; Jeffries, Marisa A. ; Jordan-Sciutto, Kelly L. ; Singhal, Anushka

The use of antiretroviral (ART) treatment during pregnancy has dramatically reduced rates of perinatally-acquired human immunodeficiency virus 1 (HIV-1) infection to <1% in the United States. Despite this success, we have limited knowledge of how ART drugs that cross the placental barrier affect fetal development, particularly in the central nervous system (CNS). During gestation, large populations of oligodendroglia are produced that are responsible for critical postnatal CNS myelination enabling appropriate neurological function. Previous studies have shown that antiretrovirals impair oligodendrocyte (OL) differentiation leading us to hypothesize that OL maturation might be inhibited by exposure to a frontline ART drug cocktail (Triumeq®) prescribed during pregnancy containing dolutegravir (DTG), abacavir (ABC), and lamivudine (3TC). In this study, we demonstrated that exposing primary rat oligodendrocyte precursor cells (OPCs) and OLs to the Triumeq drug combination decreased OL maturation and myelin protein production in a concentration-dependent manner, and that DTG was solely responsible. Regardless of the timing of exposure during OL development, a high concentration of DTG inhibited OL maturation. Bulk RNA sequencing revealed transcriptional changes after DTG exposure related to a variety of cellular mechanisms, including cellular responses to stress pathways, amino acid starvation, and mitochondrial dysfunction. Although we found that DTG robustly activated the integrated stress response (ISR), attempted rescue experiments showed that DTG primarily inhibits OL maturation independently of the ISR. Collectively, our novel data on DTG underscore the necessity of investigating how ART drugs that are administered during pregnancy and cross the placental barrier can affect fetal CNS development.

News (Medical) associated with Abacavir Sulfate

01 Jun 2025

·www.x-chemrx.com

Flow Chemistry for Contemporary Isotope Labeling

By Mounir Raji, Senior Scientist Isotope-labeled compounds have emerged as important tools in drug discovery and development. The incorporated isotopes, particularly deuterium, in pharmaceuticals, have been shown to improve ADME properties compared to their non-isotopically labeled counterparts. Since 2006, the FDA has approved >10 drugs labeled with stable isotopes such as deutetrabenazine (deuterated), deucravacitinib (deuterated) and lubiprostone (C13-labeled). Traditionally, isotope-labeled compounds are generated by different methods, e.g., organic chemistry routes in batches using isotopically enriched starting materials. At X-Chem, we took two synthetic directions to improve the cost-effectiveness, regioselectivity, versatility and the yield of isotope-labeling reactions. We specifically developed two methodologies to address current challenges in deuterium- and C13-labeling: Using late-stage direct hydrogen isotopic exchange (HIE) instead of isotopically enriched starting materials: Direct isotopic exchange allows us to perform the labeling without the need for prefunctionalization. It’s also cost-efficient, due to the availability of reagents, such as D2O or 13CO2. Atom-economy-wise, the labeling can be introduced at a specific position without constructing the entire molecule, which adds to another advantage — more applicable to synthesizing complex natural products or pharmaceuticals. Using flow synthesis instead of batch synthesis: Flow chemistry can offer numerous advantages compared to traditional batch chemistry, such as precise control of reactions parameters (e.g., temperature, reaction time), improved mixing and enhanced safety. We surmised that isotope labeling can also benefit from flow conditions. Highly selective deuterium labeling Inspired by Sajiki’s work using Pd/C, D2O and catalytic amount of D2 gas to label nucleobases, we screened different substrates with several readily available heterogenous catalysts under flow conditions. Of all the tests, Raney nickel had shown superior deuterium incorporation and could be fine-tuned by pretreatment with caffeine. From those results, we then optimized the reactions to develop a continuous flow Raney nickel-catalyzed HIE process, which was published in Advanced Synthesis & Catalysis. The process is compatible with nitrogen-containing heterocycles and pharmaceutical compounds, as we successfully labeled various purine bases, imidazole, pyridine as well as complex pharmaceuticals such as abacavir and remdesivir at high yields. Controlled ¹³CO2 gas generation The most common source of ¹³C is ¹³CO₂ gas, which is typically available in cylinders. Achieving sufficient mixing and controlling the stoichiometry of multiphase (e.g., gas-liquid) reactions can be challenging. Moreover, these cylinders often necessitate excess pressure and are costly. As a solution, we developed an on-demand ¹³CO₂ flow chamber. The chamber is based on a “tube-in-tube” flow reactor. This gas-liquid reactor comprises of a Teflon membrane encased in a PTFE tube. This design leverages the principle of diffusion to facilitate the transfer of the reactive gas into the solution stream during the synthesis. The use of Na213CO3 as a precursor allows for greater control over reaction stoichiometry, yielding a series of C13-labeled products such as bioactive ureas and 13C-carboxylic acids with high efficiency. Applications Beyond Pharmaceuticals Deuterated and C13-labeled compounds are used in various fields even beyond pharmaceuticals or metabolic studies. For example, in mass spectrometry, labeled compounds serve as internal standards for quantification. In kinetic isotope effect studies, labeled compounds are used to interrogate reaction mechanisms and transition state structures. We envision that with our improved synthetic methods, isotopically labeled compounds could be generated more efficiently and cost-effectively. Accelerate Your Small Molecule Drug Discovery With X-Chem. United States X-Chem Global HQ 100 Beaver Street Waltham, MA 02453 United States Map Canada X-Chem Canada 4800 Rue Levy Montreal, QC H4R 2P1 Canada Map Hungary X-Chem Europe Graphisoft Park (Building D) 1031 Budapest, Záhony u. 7. Hungary Map Terms & Conditions © 2026 X-Chem, Inc. • All Rights Reserved X-Chem may contact you with relevant updates. Unsubscribe anytime. See our Privacy Policy. © 2026 X-Chem, Inc. • All Rights Reserved

Drug Approval

26 Feb 2025

·investors.alector.com

Alector Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

Topline data from the pivotal INFRONT-3 Phase 3 clinical trial of latozinemab in FTD-GRN expected by Q4 2025 Anticipate completing enrollment in the PROGRESS-AD Phase 2 clinical trial of AL101/GSK4527226 in participants with early Alzheimer’s disease by mid-2025 Applying Alector Brain Carrier to advance therapeutic candidates, including those targeting amyloid beta and replacing GCase $413.4 million in cash, cash equivalents and investments provide runway through 2026 Management to host conference call and webcast today at 4:30 p.m. ET/1:30 p.m. PT SOUTH SAN FRANCISCO, Calif., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a late-stage clinical biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, today reported fourth quarter and full year 2024 financial results and recent portfolio and business updates. As of December 31, 2024, Alector’s cash, cash equivalents and investments totaled $413.4 million. “Alector is entering a potentially transformative period for the company, as we continue to advance our clinical programs toward key milestones while also driving the development of our wholly owned, early-stage pipeline,” said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. “We look forward to reporting topline data from the pivotal INFRONT-3 Phase 3 trial of latozinemab targeting frontotemporal dementia with a granulin gene mutation by the fourth quarter. Additionally, we expect to complete enrollment in the PROGRESS-AD Phase 2 trial of AL101/GSK4527226 in participants with early Alzheimer’s disease by mid-2025. With our broad and diverse portfolio of genetically validated drug candidates for the treatment of neurodegenerative diseases, backed by a strong financial position that will fund operations through 2026, Alector is well-positioned to advance our mission to deliver transformative therapies for patients with neurodegenerative brain disorders.” Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development at Alector, added, “We are making significant progress in advancing Alector’s preclinical and research pipeline. By leveraging our expertise in neuroscience and drug discovery, and selectively applying our proprietary Alector Brain Carrier technology platform, we are able to enhance brain delivery and biodistribution of therapeutic cargo to potentially improve safety and efficacy. We are currently selecting lead candidates for two programs, ADP037-ABC, targeting amyloid beta, and ADP050-ABC, replacing GCase. We aim to advance these programs toward IND-enabling studies later this year, with plans to enter the clinic in 2026.” Recent Clinical Updates Progranulin Programs (latozinemab (AL001) and AL101/GSK4527226) Being Developed in Collaboration with GSK Latozinemab The pivotal, randomized, double-blind, placebo-controlled INFRONT-3 Phase 3 clinical trial of latozinemab targeting frontotemporal dementia with a granulin gene mutation (FTD-GRN) is ongoing. Topline data are anticipated by the fourth quarter of 2025. Latozinemab is a novel investigational human monoclonal antibody (mAb) designed to block and downregulate the sortilin receptor to elevate the level of progranulin (PGRN) in the brain. It has been granted Orphan Drug, Breakthrough Therapy and Fast Track designations, and the company believes it is the most advanced PGRN-elevating candidate in development for this condition. AL101/GSK4527226 PROGRESS-AD, a global, randomized, double-blind, placebo-controlled Phase 2 clinical trial evaluating AL101/GSK4527226 in early Alzheimer’s disease (AD) continues to enroll well, with substantial progress toward its target enrollment of 282 participants. Alector and GSK plan to complete trial enrollment by mid-2025. AL101/GSK4527226 is an investigational human mAb designed to block and downregulate the sortilin receptor to elevate the level of PGRN in the brain in a manner that is similar to investigational latozinemab but with different pharmacokinetic and pharmacodynamic properties, making it suitable for the potential treatment of more prevalent neurodegenerative diseases. Preclinical and Research Pipeline Alector is advancing a preclinical and early research pipeline focused on removing toxic proteins, replacing deficient proteins, and restoring immune and nerve cell function. Leveraging its deep expertise in drug development and proprietary technologies, including protein engineering, antibody discovery, and its Alector Brain Carrier (ABC) platform for blood-brain barrier transport, the company is progressing a curated portfolio of programs targeting genetically validated disease mechanisms. This approach has led to a suite of innovative programs with the potential to make a significant impact on neurodegeneration. ADP037-ABC is a proprietary anti-amyloid beta (Aβ) antibody paired with the company’s ABC for the treatment of AD. It is designed to remove brain Aβ plaques, with the potential to reduce the incidence and/or severity of amyloid-related imaging abnormalities (ARIA) and enable subcutaneous delivery. It targets a validated epitope, specific to brain Aβ plaques, combined with an optimized antibody constant region to enhance phagocytosis of Aβ plaques. By leveraging ABC technology, ADP037-ABC aims to clear Aβ efficiently, thereby reducing plaque accumulation and potentially slowing disease progression while minimizing ARIA. ADP050-ABC is a GCase replacement therapy paired with the company’s proprietary ABC for GBA gene mutation carriers with Parkinson’s disease (PD) and Lewy body dementia. In these patients, mutations in the GBA gene lead to deficient GCase activity. ADP050-ABC uses Alector-engineered GCase, which is proprietary and has been designed to have a longer half-life and to break down glucocerebroside, a lipid that accumulates in neurons and contributes to neurodegeneration. This mechanism aims to reduce cellular dysfunction and slow disease progression. ADP056 is a Reelin modulator designed to block tau pathology and promote synaptic function in AD. Reelin, a large, secreted protein, regulates neuronal function and tau accumulation. Gain-of-function Reelin variants protect against familial AD through a mechanism that appears to uncouple amyloid and tau pathology. ADP056 is designed to mimic these protective effects of the Reelin mutation. ADP063-ABC and ADP064-ABC are therapeutic candidates paired with the company’s proprietary ABC that target tau pathology in AD through distinct approaches. First, ADP063-ABC will focus on combining a proprietary anti-tau antibody directed to a validated tau epitope with ABC and an optimized antibody constant region. It is designed to block the spread of tau aggregates and has the potential for subcutaneous delivery. Second, ADP064-ABC will focus on using an anti-tau siRNA combined with ABC, which aims to prevent the synthesis of the tau mRNA and protein. Both approaches seek to leverage a highly brain-penetrant approach to remove toxic tau and potentially slow cognitive decline in AD. In December 2024, Alector and co-recipient University of Luxembourg were awarded a $1.7 million grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) for collaborative research on glycoprotein nonmetastatic melanoma protein B (GPNMB), a PD target. Alector plans to hold an educational webinar in the second quarter of 2025 to present additional preclinical data on the company’s anti-amyloid beta and GCase programs, as well as advancements in ABC. TREM2 Program (AL002) On April 5, 2025, Alector plans to present the results from the INVOKE-2 Phase 2 clinical trial, which evaluated the safety and efficacy of AL002, a TREM2 agonist, in individuals with early AD, during an oral presentation at the AD/PD™ 2025 International Conference on Alzheimer’s and Parkinson’s Diseases, taking place in Vienna, Austria. While the trial did not meet its primary endpoint, Alector remains committed to advancing the understanding of AD pathophysiology and the development of effective therapeutics for the disease. Fourth Quarter 2024 Financial Results Revenue. Collaboration revenue for the quarter ended December 31, 2024, was $54.2 million, compared to $15.2 million for the same period in 2023. Collaboration revenue for the year ended December 31, 2024, was $100.6 million, compared to $97.1 million for the same period in 2023. The increase in year-over-year collaborative revenue was primarily due to an increase in revenue recognized for the AL002 and latozinemab programs. Collaboration revenue under the AbbVie Agreement was fully recognized as of December 31, 2024. R&D Expenses. Total research and development expenses for the quarter ended December 31, 2024, were $46.5 million, compared to $47.7 million for the quarter ended December 31, 2023. Total research and development expenses for the year ended December 31, 2024, were $185.9 million compared to $192.1 million for the same period in 2023. The decrease in year-over-year R&D expenses was mainly due to the Company’s strategy to prioritize selected programs. G&A Expenses. Total general and administrative expenses for the quarter ended December 31, 2024, were $15.0 million compared to $14.9 million for the quarter ended December 31, 2023. Total general and administrative expenses for the year ended December 31, 2024, were $59.6 million compared to $56.7 million for the year ended December 31, 2023. The increase in year-over-year G&A expenses is primarily due to the impairment of the right-of-use asset and the leasehold improvements as the Company approved a plan to transition operations from our laboratory and offices in Newark, California to our South San Francisco Headquarters. Net Loss. For the quarter ended December 31, 2024, Alector reported a net loss of $2.1 million, or $0.02 net loss per share, compared to a net loss of $41.4 million, or $0.49 net loss per share, for the same period in 2023. For the year ended December 31, 2024, Alector reported a net loss of $119.0 million or $1.23 net loss per share, compared to a net loss of $130.4 million or $1.56 net loss per share, for the same period in 2023. Cash Position. Cash, cash equivalents, and investments were $413.4 million as of December 31, 2024. Management expects that this will be sufficient to fund current operations through 2026. 2025 Guidance. Management anticipates, for the year ending 2025, collaboration revenue to be between $5 million and $15 million, total research and development expenses to be between $175 million and $185 million, and total general and administrative expenses to be between $55 million and $65 million. Fourth Quarter and Full Year 2024 Conference Call Alector’s management team will host a conference call to discuss Alector’s results for the fourth quarter and full year 2024, as well as provide a business update. The conference call will be webcast and accessible via the investor relations section of Alector’s website at www.alector.com. To access the call, please use the following information: Date: Wednesday, February 26, 2025 Time: 4:30 p.m. ET, 1:30 p.m. PT The event will be webcast live under the investor relations section of Alector’s website at https://investors.alector.com/events-and-presentations/events and following the event a replay will be archived there for 30 days. Interested parties participating by phone will need to register using this online form. After registering for dial-in details, all phone participants will receive an auto-generated e-mail containing a link to the dial-in number along with a personal PIN number to use to access the event by phone. About Alector Alector is a late-stage clinical biotechnology company focused on developing therapies to counteract the devastating progression of neurodegenerative diseases. Leveraging the principles of genetics, immunology and neuroscience, the company is advancing a portfolio of genetically validated programs that aim to remove toxic proteins, replace missing proteins, and restore immune and nerve cell function. Supported by biomarkers, Alector’s product candidates seek to treat a range of indications, including frontotemporal dementia, Alzheimer’s disease, Parkinson's disease, and Lewy body dementia. The company is also developing Alector Brain Carrier (ABC), a proprietary blood-brain barrier platform, which is being selectively applied to its next-generation product candidates and research pipeline. ABC aims to enhance the delivery of therapeutics, achieve deeper brain penetration and efficacy at lower doses, and ultimately improve patient outcomes while reducing costs. Alector is headquartered in South San Francisco, California. For more information, please visit www.alector.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding our business plans, business strategy, product candidates, blood-brain barrier technology platform, research and preclinical pipeline, planned and ongoing preclinical studies and clinical trials, anticipated timing of and detail regarding release of data for INFRONT-3, expected milestones, expectations of our collaborations, expectations of our interactions with regulatory authorities, and financial and cash guidance. Such statements are subject to numerous risks and uncertainties, including but not limited to risks and uncertainties as set forth in Alector’s Quarterly Report on Form 10-K filed for 2024, with the Securities and Exchange Commission (“SEC”), as well as the other documents Alector files from time to time with the SEC. These documents contain and identify important factors that could cause the actual results for Alector to differ materially from those contained in Alector’s forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alector specifically disclaims any obligation to update any forward-looking statement, except as required by law. Alector Contacts: Alector Katie Hogan 202-549-0557 katie.hogan@alector.com Argot Partners (media) David Rosen (212) 600-1494 alector@argotpartners.com Argot Partners (investors) Laura Perry 212-600-1902 alector@argotpartners.com Source: Alector, Inc.

Phase 2Phase 3Financial StatementBreakthrough TherapyOrphan Drug

24 Jan 2025

·pharma.economictimes.indiatimes.com

Biggies to face new contender in HIV as Lupin generics secures tentative approval from FDA

Mumbai: Generics drug maker Lupin Limited announced that it has received tentative approval from the FDA under the US President’s Emergency Plan for AIDS Relief for its Abacavir, Dolutegravir and Lamivudine tablets for oral suspension. Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen, indicated for the treatment of HIV-1 infection in pediatric patients aged at least 3 months and weighing at least 6 kg. This product would be manufactured at the company's Nagpur facility in India and will be supplied to low-and middle-income countries, the release stated. Ramesh Swaminathan, Executive Director, Global CFO & Head -API Plus SBU, Lupin said, “We are committed to providing affordable and high-quality treatments for patients worldwide. The tentative approval from the U.S. FDA for our Abacavir, Dolutegravir and Lamivudine Tablets enables us to improve the well-being of pediatric patients with HIV-1, thereby significantly boosting our HIV medication portfolio.” The generic version is equivalent to Triumeq PD Tablets for Oral Suspension, of ViiV Healthcare Company owned by GSK, with Pfizer and Shionogi as minority shareholders around 15 per cent and 5 per cent respectively. As of September 2024, Triumeq has an annual sales of $1.3 million in the US drug market and the novel drug had pediatric exclusivity till December 2026. By Online Bureau ,

Drug Approval

100 Deals associated with Abacavir Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
D00891	Abacavir Sulfate	J05AF06	DB01048

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
HIV Infections	United States	ViiV Healthcare Co.	17 Dec 1998

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hypersensitivity	Phase 3	Japan	GlaxoSmithKline KK	01 Nov 2009
AIDS Dementia Complex	Phase 3	United States	Glaxo Wellcome SA	31 Aug 2001
AIDS Dementia Complex	Phase 3	Canada	Glaxo Wellcome SA	31 Aug 2001
Acidosis, Lactic	Phase 3	Canada	GSK Plc	01 Aug 2001
Hyperlactatemia	Phase 3	Canada	GSK Plc	01 Aug 2001
Hepatitis C	Phase 1	United States	GSK Plc	01 Dec 2009

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


IAS2025	Not Applicable	HIV Infections	370	Abacavir-based regimen (HIV)	tctdthlyqx(yvvebnumsz) = ddigjnfskk jqqxcniugc (otpeqiuevz ) View more	Positive	13 Jul 2025
NCT02384395 (PHI-05, CTgov)	Not Applicable	HIV Infections	40	Dolutegravir 50 mg+Abacavir 600 mg+Lamivudine 300 mg	blhaqfpxgl = ayqbzbchnd mqelqcgmfb (mxguwebays, ardajtikxn - voeceahyee) View more	-	22 Nov 2021
NCT00214890 (CCTG584, CTgov)	Phase 2	HIV Infections	21	Tenofovir (Tenofovir)	emgpdjvbhg(udilqjnhaq) = jlllpsyuxo riuzofgryt (jipqhrsngo, axuguzextt - lmrtrzlxpo) View more	-	09 Mar 2021
				Abacavir (Abacavir)	emgpdjvbhg(udilqjnhaq) = ojsbirzvva riuzofgryt (jipqhrsngo, ezkwmafpxy - uypbitabpe) View more
IAS2021	Not Applicable	HIV Infections	-	Immediate-release (IR) ABC/DTG/3TC FDC	axvqgxgtae(idyfkajxlu) = urikxvnxza iyckupyofy (emrsbhyyoa, 15.6%) View more	-	01 Jan 2021
				Dispersible tablet (DT) ABC/DTG/3TC FDC	axvqgxgtae(idyfkajxlu) = ibuwibauew iyckupyofy (emrsbhyyoa, 16.5%) View more
NCT00102960 (CHER, CTgov)	Phase 3	HIV Infections	377	Zidovudine+Abacavir sulfate+Didanosine+Efavirenz+Lamivudine+Nevirapine+Lopinavir/Ritonavir	jlfjasprtd = qguxhrjeuj buymkggrdf (odzvrhcerg, wgpfbqerde - pvrxiefjcg)	-	30 Nov 2018
NCT01052701 (CTgov)	Phase 1	HIV Infections \| Hepatitis C	26	Abacavir+Ribavirin (Ribavirin Plus Abacavir)	qxhuruvvdg(mhsbkmcwri) = jrtwurhvgo osdlzxnuak (nalghsefbt, 12.82) View more	-	27 Apr 2017
				Ribavirin (Ribavirin Alone)	qxhuruvvdg(mhsbkmcwri) = gexwpcnpxb osdlzxnuak (nalghsefbt, 12.69) View more
NCT00928187 (2LADY, CTgov)	Phase 3	HIV Infections	454	emtricitabine/tenofovir+lopinavir/ritonavir (Arm A)	iujqwjegib = nacojqlsub hcazjpofys (bddmfzeaql, zoldvxaguf - nxjnujxyqk) View more	-	08 Nov 2016
				abacavir+didanosine+lopinavir/ritonavir (Arm B)	iujqwjegib = bfwiwbjoih hcazjpofys (bddmfzeaql, nuzfygkkpa - phbatfictm) View more
NCT01146873 (NEVEREST-III, CTgov)	Phase 3	Acquired Immunodeficiency Syndrome	300	Lopinavir/ritonavir (LPV/r) (Group 1: Lopinavir/Ritonavir (LPV/r))	lxjeazsrde(zgjjbuqwpv) = xlfwdotrtn gaeifvtvxf (vsdffkapfa, gbourxniko - sljoobuntx) View more	-	04 May 2016
				Efavirenz (EFV) (Group 2: Efavirenz (EFV))	lxjeazsrde(zgjjbuqwpv) = xmykvyeuae gaeifvtvxf (vsdffkapfa, odvwavkmby - hszootswim) View more
NCT01352715 (A5273 \| SELECT, CTgov)	Phase 3	HIV Infections	515	Lopinavir/ritonavir+raltegravir (Arm A: LPV/r Plus RAL)	jzuvemnlbv = nbkuwfdzzn kyauatjpvn (yxjcsuyocf, qfivwbqjco - bvnujnhnox) View more	-	06 Jan 2016
				Abacavir/lamivudine+Zidovudine+Abacavir+Lamivudine/zidovudine+Abacavir/lamivudine/zidovudine+Emtricitabine/tenofovir disoproxil fumarate+Lamivudine+Lopinavir/ritonavir (Arm B: LPV/r Plus Best Available NRTIs)	jzuvemnlbv = xqiiqlnqop kyauatjpvn (yxjcsuyocf, phyekerbdp - ogegrwfyto) View more
NCT01153217 (OsteoTDF study, Pubmed \| J Antimicrob Chemother)	Phase 3	Bone Diseases, Metabolic	54	Switch from tenofovir to abacavir	ysdvrxbsde(xamxldsjbd) = izlojtnrvd gvfvxalwip (nibkkeakos, -3.8 to 3.3) View more	-	01 Dec 2014
				Continue with tenofovir	ysdvrxbsde(xamxldsjbd) = ycpieklkrk gvfvxalwip (nibkkeakos, -3.8 to 0.4) View more

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