A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of 20-hydroxyecdysone (20E) in Reducing the Muscle Strength Loss From the GLP1 Agonist Semaglutide in Combination With Dieting in Obese and Overweight Adult Patients (OBA).

The goal of this clinical trial is to learn if BIO101 treatment can improve the muscle strength of participants males and females, aged 18 to 84 years old, suffering from obesity (BMI≥30) or overweight (BMI ≥ 27) with one or more sequelae (e.g., hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease, but excluding diabetes), and treated with semaglutide, a GLP1 agonist for 21 weeks. The main questions it aims to answer are:
* Is BIO101 administered orally improving muscle strength, as measured with knee extension strength (using isokinetic dynamometry)?
* Is BIO101 administration leading to additional medical problems for patients suffering from obesity or overweight with sequelae and treated with semaglutide? After the end of the study (after last patient did the last visit at the clinic), researchers will compare the BIO101-treated arm to the placebo control arm to see if the candidate drug has an effect on muscle strength, physical function, lean body mass and health related quality of life compared to placebo. BIO101 is the candidate drug and placebo is a look-alike substance that does not contain any active drug
Participants will be asked to:
* Take 2 pills every morning and every evening of BIO101 or placebo orally for 21 weeks.
* Simultaneously, take semaglutide for 21 weeks while being on caloric restriction, following the doctor recommendation and approved prescribing information for semaglutide, with dose increasing up to at least a dose level of 1.7 mg and a maximum dose level of 2.4 mg.
* Come to investigational site at screening, baseline, week 6, 13, 21 and week 33 (12 weeks after the end of treatment) for checkups and tests.
* Answer to phone calls at week 25 and 29 as well (4 and 8 weeks after the end of treatment) on global health status and quality of life.

Start Date01 Jul 2026

Sponsor / Collaborator

Biophytis SA

CTIS2022-502417-28-01

/ Not yet recruitingPhase 3

SARA-31: A phase 3 trial to evaluate the efficacy and safety of BIO-101 in elderly patients suffering from severe SARcopeniA: an interventional, randomized double-blind placebo- controlled, clinical trial.

Start Date01 Dec 2025

Sponsor / Collaborator

Biophytis SA

NCT04472728

/ TerminatedPhase 2/3

Adaptive Design, Phase 2-3, Randomized, Double-blind, Multicenter Study, Evaluating Safety, Efficacy, PK-PD of BIO101 in Prevention of Respiratory Deterioration in Hospitalized Patients With COVID-19 Pneumonia (Severe)

The COVA clinical study is a global multicentric, double-blind, placebo-controlled, group sequential and adaptive 2 parts phase 2-3 study targeting in participants with SARS-CoV-2 pneumonia. Part 1 is a Phase 2 exploratory Proof of Concept (PoC) study to provide preliminary data on the activity, safety and tolerability of BIO101 in the target population. Part 2 is a phase 3 pivotal randomized study to provide further evidence of safety and efficacy of BIO101 after 28 days of double-blind dosing. BIO101 is the investigational new drug that activates the Mas receptor (MasR) through the protective arm of the Renin Angiotensin System (RAS).

Start Date26 Aug 2020

Sponsor / Collaborator

Biophytis SA

100 Clinical Results associated with Ruvembri

100 Translational Medicine associated with Ruvembri

100 Patents (Medical) associated with Ruvembri

4,411

Literatures (Medical) associated with Ruvembri

01 Aug 2026·PEST MANAGEMENT SCIENCE

A novel cytochrome P450 gene, CYP12A2 , regulates reproduction of Mythimna separata by modulating 20E biosynthesis

Article

Author: Dai, Changgeng ; Liao, Jing ; Li, Wenmeng ; Li, Peiying ; Li, Lingling ; Li, Hongbo

Abstract:

BACKGROUND:

Several P450 genes in the 20‐hydroxyecdysone (20E) signaling pathway are known to critically regulate reproductive development in insects. However, the contribution of other P450 family members to insect reproduction remains poorly characterized.

RESULTS:

Here, we identified a novel P450 gene, CYP12A2 , from the highly polyphagous pest Mythimna separata . Quantitative real‐time polymerase chain reaction analysis revealed that CYP12A2 was upregulated during sexual maturation and predominantly enriched in the ovaries of 3‐day‐old female adults. RNA interference (RNAi)‐mediated knockdown of CYP12A2 severely disrupted ovarian development and downregulated the expression of vitellogenesis‐related genes ( Vg and VgR ) as well as eggshell formation‐related genes ( CB‐Ld329 and FCP3C ), ultimately leading to reduced fecundity. Moreover, silencing of CYP12A2 significantly decreased 20E titers and suppressed the expression of key 20E biosynthetic genes ( CYP307A1 , CYP306A1 , CYP302A1 and CYP315A1 ). Importantly, exogenous 20E injection substantially rescued the defects in ovarian development and restored the expression of reproduction‐related genes that were impaired by CYP12A2 depletion.

CONCLUSION:

These findings indicate that CYP12A2 regulates reproduction of M. separata by modulating 20E biosynthesis. Our study uncovers a novel reproductive role for CYP12A2 and highlights its potential as a target for RNAi‐based pest management strategies. © 2026 Society of Chemical Industry.

01 Jul 2026·INSECT BIOCHEMISTRY AND MOLECULAR BIOLOGY

EcR-JHAMT3 axis regulates reproductive plasticity in the predatory beetle Harmonia axyridis

Article

Author: Lu, Lian-Ming ; Xu, Shuo ; Lv, Jia ; Pu, Zhan-Xu ; Huang, Zhen-Dong ; Zhu, Li

Ecdysone (20-hydroxyecdysone, 20E) is a master regulator of insect development, but its function in adult reproduction-particularly in predatory species-remains poorly understood. We employed Harmonia axyridis to explore 20E signaling in reproduction regulation through RNAi, transcriptomic analysis, and hormone rescue assays. The results demonstrated that both JH and 20E biosynthesis were activated in aphid-fed females, whereas injection of 1.0 μg 20E effectively promoted ovarian development in artificial diet-fed individuals. Expression of the 20E receptor EcR was significantly upregulated in aphid-fed H. axyridis females. EcR silencing severely arrested ovarian development and reduced Vg expression. Transcriptomic analysis revealed that the insect hormone biosynthesis pathway (ko00981) serves as the crucial downstream pathway of EcR-mediated reproductive regulation, with JHAMT3 identified as the core effector. JHAMT3 silencing phenocopied the reproductive suppression observed in EcR-silenced beetles, while exogenous JHA and JH III treatment effectively rescued ovarian development in both cases. Furthermore, multiple high-confidence EcR binding motifs were predicted in the JHAMT3 promoter, and two binding sites (5'-AACTACACTGCCATC-3', 5'-AAGATCCTTGAATTT-3') were verified through EMSA and dual-luciferase reporter assays. These findings establish an EcR-JHAMT3-reproduction regulatory axis in H. axyridis, offering a mechanistic framework for understanding reproductive plasticity in predatory insects.

01 Jul 2026·INSECT BIOCHEMISTRY AND MOLECULAR BIOLOGY

Histone acetyltransferases and N-terminal acetyltransferases orchestrate development and metamorphosis in the yellow fever mosquito, Aedes aegypti

Article

Author: Palli, Subba Reddy ; Gaddelapati, Sharath Chandra

Mosquitoes, especially Aedes aegypti, transmit major human diseases such as dengue, Zika, and chikungunya. Epigenetic regulation, including histone acetylation, plays a key role in controlling Ae. aegypti development. However, the specific roles of histone acetyltransferases (HATs) and N-terminal acetyltransferases (NATs) in mosquito development remain poorly understood. In this study, we investigated 25 HAT/NAT genes functions by knocking them down via feeding Ae. aegypti larvae with dsRNA nanoformulations. Gene expression analysis confirmed that target gene expression was reduced by more than 50% in dsRNA-treated larvae. Knocking down 18 of these HATs/NATs resulted in over 50% mortality. Silencing KAT7, NATSCAN, NAT9, ATAT1, and TADA3 caused larval death, whereas knockdown of NAA80, NAA-Eco, GNPNAT1, HAT-B, and MCM3AP led to pupal mortality. Knockdown of NATSCAN, NF, TFIID, GNPNAT1, and NAA16 resulted in molting and metamorphic defects, characterized by untanned cuticles and failure to complete successful larval-pupal metamorphosis. Phylogenetic analysis of conserved domains of HATs and NATs revealed that evolutionarily conserved members cluster into distinct clades associated with larval- or pupal-specific functions. Developmental expression analysis showed stage-specific expression of these genes. Further, stage-specific expression analysis revealed that dynamic expression patterns of KAT7, RNACAT, NAT9, and NF are linked to larval growth and pupal metamorphosis. Treatment with 20-hydroxyecdysone (20E) or an ecdysone agonist increased mRNA levels of NAA30,NAA40,NAT9, and GNAT8, indicating hormonal control of histone acetylation. Ecdysone-induced HATs/NATs regulated the expression of primary ecdysone response genes: E75A and E93. These results demonstrate that HATs/NATs play key roles in Ae. aegypti development and therefore could serve as potential targets for mosquito control.

108

News (Medical) associated with Ruvembri

13 Jul 2026

·www.prnewswire.com

Boostimmune Secures Japanese Patent for Sequence-Independent TCTP Antibody Technology Targeting MDSC Accumulation

Japanese patent granted for technology that inhibits TCTP released from dead tumor cells using antibodies to suppress the accumulation of MDSCs in the tumor microenvironment Granted claims are not expressly limited to specific antibody CDRs or amino acid sequences, but are defined by function and therapeutic use Patent claims cover inhibition of PMN-MDSC accumulation as well as cancer therapeutics and therapeutic compositions containing the inhibitor Strengthens the core intellectual property portfolio supporting the development of BIO101 and the global commercialization of TCTP-targeting antibodies SEOUL, South Korea, July 13, 2026 /PRNewswire/ -- Boostimmune announced on July 13, 2026 that it has secured a Japanese patent covering technology that uses antibodies to inhibit the function of translationally controlled tumor protein (TCTP) released from dead tumor cells, thereby suppressing the accumulation of myeloid-derived suppressor cells (MDSCs) in the tumor microenvironment. The granted claims are not expressly limited to the individual complementarity-determining regions (CDRs) or amino acid sequences of a specific antibody. Instead, they functionally define an anti-TCTP antibody that inhibits the activity of TCTP released from dead tumor cells and suppresses MDSC accumulation in the tumor microenvironment. The claims also cover inhibition of polymorphonuclear MDSC (PMN-MDSC) accumulation and cancer therapeutics or therapeutic compositions containing the inhibitor as an active ingredient. Through this patent, Boostimmune has strengthened its intellectual property position in Japan not only for its proprietary BIO101 antibody candidate, but also for the development of therapeutics that modulate the immunosuppressive tumor microenvironment through the claimed TCTP-targeting mechanism. BIO101 is a novel immuno-oncology program designed to regulate MDSCs, one of the major immunosuppressive cell populations in the tumor microenvironment. Although TCTP has primarily been known for its intracellular functions, it can be released into the extracellular space during tumor cell death. Extracellular TCTP may act on immunosuppressive myeloid cells, promote the recruitment and accumulation of MDSCs within tumors, and contribute to the suppression of antitumor immune responses. Boostimmune is developing a therapeutic strategy that blocks extracellular TCTP with an antibody, with the aim of reducing MDSC accumulation in tumors and restoring antitumor immune activity. The company believes that the newly granted patent may represent an important intellectual property right to consider in connection with the clinical development, licensing, and commercialization in Japan of TCTP-targeting antibody therapeutics based on the same or a similar mechanism of action. BIO101 originated from research conducted by the laboratory of Tadatsugu Taniguchi, Professor Emeritus at the University of Tokyo and a globally recognized immunologist. The program was subsequently in-licensed by Boostimmune. Professor Taniguchi's research team demonstrated that extracellular TCTP released from tumor cells can act on immunosuppressive myeloid cells and promote the accumulation of MDSCs within tumors. The findings were published in Nature Immunology in 2021. Professor Taniguchi is also a co-founder of Boostimmune. Building on this research, Boostimmune has identified antibodies that block TCTP function and has advanced candidate optimization and preclinical development based on antibody binding properties, inhibition of MDSC accumulation, and activation of antitumor immune responses. "This Japanese patent is significant because it is not limited to the sequence of a single BIO101 antibody," said Gwanghee Lee, Ph.D., Chief Executive Officer of Boostimmune. "Rather, the granted claims are centered on the function of inhibiting TCTP released from dead tumor cells to suppress MDSC accumulation in tumors, as well as the related therapeutic uses and compositions." He added, "Because this patent may be relevant to the development and commercialization of therapeutics that use TCTP antibodies to regulate the immunosuppressive tumor microenvironment through the same or a similar mechanism, we intend to accelerate the development of BIO101 while actively pursuing strategic collaborations with global pharmaceutical and biotechnology companies." Boostimmune is an oncology-focused biotechnology company co-founded in 2021 by Gwanghee Lee and Professor Tadatsugu Taniguchi. The company is developing multiple biologics-based oncology programs, including BIO101, an immuno-oncology program targeting TCTP, as well as novel antibody-drug conjugate programs. CONTACT: [email protected] SOURCE Boostimmune 21% more press release views with Request a Demo

ImmunotherapyADC

13 Mar 2026

·www.prnewswire.com

Biophytis-LynxKite Alliance Expands to Turbocharge AI-driven drug discovery for next generation longevity therapeutics

Biophytis and LynxKite launch new modalities beyond MASSIVE: AI-driven drug discovery for next-generation longevity therapies This partnership will generate revenue through: A computational longevity platform, including unique curated datasets and accelerated computation methods relevant for longevity research Next-generation drug candidates against sarcopenia Next generation drug candidates for dry age-related macular degeneration SINGAPORE, PARIS and CAMBRIDGE, Mass., March 13, 2026 /PRNewswire/ -- Lynxkite is expanding its partnership with Biophytis SA (Euronext Growth Paris: ALBPS) ("Biophytis"), starting with the MASSIVE project (MAS Receptor Synthetic Innovation & Virtual Engineering for Sarcopenia therapy) and plans to expand the platform to other modalities. This strategic initiative, also supported by Singapore's Enterprise Singapore, is aligned with priority target areas in Singapore's Research, Innovation and Enterprise (RIE) 2030 plan. Continue Reading LynxKite Technologies, a leader in advanced analytics and artificial intelligence, known for its flagship open-source platform LynxKite, will integrate AI computational methods relevant for longevity research into its computational orchestration platform. With over a decade of experience, the founding team of LynxKite has supported more than 100 global enterprises — including major players such as Roche, AstraZeneca and Hummingbird Biosciences — in analyzing complex data using graph-based and generative AI approaches. The first MASSIVE project aims to identify and develop Mas receptor (MasR) activator drug candidates targeting sarcopenia, a degenerative muscle disease associated with aging that affects millions of elderly people worldwide. Biophytis contributes its deep expertise in age-related diseases, its preclinical experience in MasR-linked indications, and its expertise in Mas receptor pharmacology. LynxKite brings state-of-the-art AI technologies, chemoinformatics, and software engineering coupled with scaling GPU computation on the latest generation of NVIDIA toolkits and neoclouds such as Nebius. Together, the partners strengthen Biophytis' strategic drug discovery program, aligned with its longevity-focused strategy and positioning. The project's key objectives include: Modeling the Mas receptor for structure-based drug design using AI and protein prediction tools. Designing and prioritizing synthetic drug candidates through AI-guided molecule generation and predictive filtering. Synthesizing and testing promising MasR activators to assess biological activity, safety, and pharmacokinetics. Selecting and protecting the lead candidate through patent filings in preparation for preclinical development. Developing and validating the AI software via feedback loops from in vitro and in vivo validation of candidates. "The launch of MASSIVE marks a decisive step in our longevity strategy, combining our clinical expertise with LynxKite's innovative AI to accelerate the discovery of transformative therapies against sarcopenia," said Stanislas Veillet, CEO of Biophytis. Gyorgy Lajtai, CEO of LynxKite, added: "We are proud to collaborate with Biophytis on pioneering computational longevity through our LynxKite platfom, which demonstrates how LynxKite can revolutionize discovery by designing, integrating and orchestrating relevant computational tools in diverse modalities." About LynxKite LynxKite Technologies Pte Ltd, headquartered in Singapore with offices in the United States, Switzerland The LynxKite platform combines graph analytics, biological language models, while directly managing, optimizing, and autoscaling GPU resources to efficiently run complex pipelines such as NVIDIA NIM Microservices. Building on more than a decade of experience in graph and enterprise AI, LynxKite collaborates with research institutions, technology partners, and industry leaders to accelerate scientific discovery and advanced analytics. For more information, please visit . About BIOPHYTIS Biophytis SA is a clinical-stage biotechnology company focused on developing drug candidates for age-related diseases. BIO101 (20-hydroxyecdysone), our lead drug candidate, is a small molecule in development for muscular diseases (sarcopenia, Phase 3 ready to start) and metabolic disorders (obesity, Phase 2 ready to start). The company is headquartered in Paris, France, with subsidiaries in Cambridge, Massachusetts, USA, and Brazil. The Company's ordinary shares are listed on Euronext Growth Paris (ALBPS - FR001400OLP5) and its ADS (American Depositary Shares) are listed on the OTC market (BPTSY - US 09076G401). For more information, visit . About Nebius Nebius, the AI cloud company, is building the full-stack platform for developers and companies to take charge of their AI future — from data and model training to production deployment. Founded on deep in-house technological expertise and operating at scale with a rapidly expanding global footprint, Nebius serves startups and enterprises building AI products, agents, and services worldwide. Nebius is listed on Nasdaq (NASDAQ: NBIS) and headquartered in Amsterdam. For more information, please visit . SOURCE Biophytis; LynxKite Technologies 21% more press release views with Request a Demo

Phase 2Phase 3

13 Oct 2025

·endpoints.news

SystImmune’s $250M milestone; Teva’s Uzedy approved to treat bipolar disorder

Plus, news about Avidity, Biophytis, the Novo Nordisk Foundation, ADC Therapeutics and Apogee Therapeutics: 💸 SystImmune to get $250M from Bristol Myers Squibb: The milestone payment is the result of the first patient being dosed in a Phase 2/3 trial for izalontamab brengitecan in some patients with triple-negative breast cancer. The companies inked a deal in 2023 worth up to $7.1 billion to develop iza-bren outside of China. — Jaimy Lee 🏛 FDA approves Teva’s Uzedy for bipolar I disorder: The subcutaneous drug can now be marketed as a maintenance treatment for adults with the disorder. Uzedy, which was first approved in 2023 to treat schizophrenia, brought in $117 million in sales last year. — Jaimy Lee 🗂️ Avidity Biosciences pushes back FDA filing: The RNA medicines company now plans to submit a BLA for del-zota in the first quarter of 2026 and not before the end of this year, as it previously said. The decision is to “ ensure the FDA receives additional data” with regard to CMC. The San Diego biotech is developing an experimental medicine for Duchenne patients whose gene mutations are amenable to exon 44 skipping. The company last month raised $690 million in an offering. The Financial Times reported in August that Novartis was considering an acquisition of Avidity. — Kyle LaHucik 💼 Biophytis to start joint venture and sarcopenia trial: A consortium of investors, including the Chinese conglomerate Ronghui Renhe Life Technology, plans to form a Hong Kong-based joint venture with the company. The investors are expected to fork over up to $20 million over the next two years to fund the first late-stage trial of Biophytis’ MAS receptor activator, BIO101, in sarcopenia. The trial is expected to recruit up to 932 patients in Europe and Asia and is set to start next year. The joint venture will exclusively sell BIO101 in China, Japan, and Korea if it is approved. — Elizabeth Cairns 🦠 New AI platform for pathogen surveillance gets funding: The Novo Nordisk Foundation is giving up to DKK 200 million ($31 million) to help build new “infrastructure” at the Technical University of Denmark that’s called the Global Pathogen Analysis Platform. The platform will be used to track and analyse infectious diseases using bioinformatics and artificial intelligence. It will also have “partner nodes” at the University of Copenhagen, Statens Serum Institut in Copenhagen and Imperial College London. — Anna Brown 💰 ADC Therapeutics’ $60M PIPE: The company is selling 11.3 million shares at $4.00 apiece to support the commercialization of Zynlonta, which was approved by the FDA in 2021. The private placement was led by TCGX. — Jaimy Lee 💵 Apogee Therapeutics ended up raising $345 million in its public offering, up from the $300 million it targeted. — Jaimy Lee

Drug ApprovalAcquisition

100 Deals associated with Ruvembri

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Sarcopenia	Phase 3	United States	Biophytis SA	01 Dec 2025
Sarcopenia	Phase 3	Belgium	Biophytis SA	01 Dec 2025
Airway Obstruction	Phase 3	United States	Biophytis SA	26 Aug 2020
Airway Obstruction	Phase 3	Belgium	Biophytis SA	26 Aug 2020
Airway Obstruction	Phase 3	Brazil	Biophytis SA	26 Aug 2020
Airway Obstruction	Phase 3	France	Biophytis SA	26 Aug 2020
COVID-19	Phase 3	United States	Biophytis SA	26 Aug 2020
COVID-19	Phase 3	Belgium	Biophytis SA	26 Aug 2020
COVID-19	Phase 3	Brazil	Biophytis SA	26 Aug 2020
COVID-19	Phase 3	France	Biophytis SA	26 Aug 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03452488 (SARA-INT, CTgov)	Phase 2	Gait Disorders, Neurologic \| Obesity \| Mobility Limitation ... View more	233	Placebo (Placebo)	ibsmpacbki(dxvouoxzav) = vgdxckvsmf bohzwxyrvf (fszxjixava, tgjriknndo - fsjptvnyeq) View more	-	01 Oct 2024
NCT03452488 (SARA-INT, CTgov)	Phase 2		233	BIO101 (175mg BIO101)	ibsmpacbki(dxvouoxzav) = kgzlpbpwpd bohzwxyrvf (fszxjixava, xeochcapaj - jpjkihefsb) View more	-	01 Oct 2024
NCT04472728 (Biospace) Manual	Phase 2/3	COVID-19	-	BIO101BIO101 (20-hydroxyecdysone)	aqmsqphtks(wdjfvdrjxb) = pyekrgqgvq xewqkldlyx (kytrmooham ) View more	Positive	01 Jul 2024
NCT04472728 (SARA-INT \| COVA, MDA2024)	Phase 2/3	Muscular Dystrophy, Duchenne	-	BIO101 350 mg bid	ygzmgqyiff(fvlelybgwt) = ldbxcfwypm zmdreprtkm (yqcbqcekly )	Positive	03 Mar 2024
NCT04472728 (COVA, Accesswire) Manual	Phase 2/3	COVID-19	233	BIO-101	furwosbcet(awopmodxng) = wznluiszjm izmuyclnxw (bzlmiufplf ) View more	Positive	07 Sep 2022
NCT04472728 (COVA, Accesswire) Manual	Phase 2/3	COVID-19	233	Placebo	furwosbcet(awopmodxng) = krkswhfezo izmuyclnxw (bzlmiufplf ) View more	Positive	07 Sep 2022

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis