Innovent Receives U.S. FDA Approval for IND Application of Oral GLP-1R Agonist IBI3032
Innovent Biologics (IVBIY) has received FDA approval for its Investigational New Drug (IND) application for IBI3032, a novel oral GLP-1 receptor agonist. The company plans to initiate Phase 1 clinical trials in both China and the U.S. during the second half of 2025.
IBI3032 demonstrated superior preclinical results, achieving 5-10 times higher oral exposure at equivalent doses compared to peer compounds. The drug showed improved efficacy and good tolerability in both GLP-1R KI DIO mice and obese monkey models, achieving comparable therapeutic effects at lower doses.
The upcoming trials will include both healthy volunteers and overweight/obese participants, targeting applications in diabetes, weight management, hypertension, and obstructive sleep apnea (OSA).
Innovent Biologics (IVBIY) ha ottenuto l'approvazione della FDA per la sua domanda di Nuovo Farmaco Sperimentale (IND) relativa a IBI3032, un nuovo agonista orale del recettore GLP-1. L'azienda prevede di avviare le prove cliniche di Fase 1 sia in Cina che negli Stati Uniti nella seconda met脿 del 2025.
IBI3032 ha mostrato risultati preclinici superiori, raggiungendo un'esposizione orale 5-10 volte maggiore a dosi equivalenti rispetto ai composti concorrenti. Il farmaco ha evidenziato una migliore efficacia e buona tollerabilit脿 sia nei modelli murini GLP-1R KI DIO sia nei modelli di scimmie obese, ottenendo effetti terapeutici comparabili a dosi inferiori.
Le prossime sperimentazioni coinvolgeranno volontari sani e partecipanti sovrappeso/obesi, con l'obiettivo di trattare diabete, gestione del peso, ipertensione e apnea ostruttiva del sonno (OSA).
Innovent Biologics (IVBIY) ha recibido la aprobaci贸n de la FDA para su solicitud de Nuevo F谩rmaco en Investigaci贸n (IND) para IBI3032, un nuevo agonista oral del receptor GLP-1. La compa帽铆a planea iniciar los ensayos cl铆nicos de Fase 1 tanto en China como en EE. UU. durante la segunda mitad de 2025.
IBI3032 demostr贸 resultados precl铆nicos superiores, logrando una exposici贸n oral 5-10 veces mayor a dosis equivalentes en comparaci贸n con compuestos similares. El medicamento mostr贸 mejor eficacia y buena tolerabilidad en modelos de ratones GLP-1R KI DIO y monos obesos, alcanzando efectos terap茅uticos comparables con dosis m谩s bajas.
Los pr贸ximos ensayos incluir谩n tanto voluntarios sanos como participantes con sobrepeso/obesidad, enfoc谩ndose en aplicaciones para diabetes, control de peso, hipertensi贸n y apnea obstructiva del sue帽o (AOS).
Innovent Biologics (IVBIY)臧赌 IBI3032鞐� 雽�頃� 鞛勳儊鞁滍棙鞖� 鞁犾暯(IND) 鞁犾箔鞐� 雽�頃� FDA 鞀轨澑鞚� 氚涭晿鞀惦媹雼�. IBI3032電� 靸堧鞖� 瓴疥惮鞖� GLP-1 靾橃毄觳� 鞛戩毄鞝滌瀰雼堧嫟. 須岇偓電� 2025雲� 頃橂皹旮办棎 欷戧淡瓿� 氙戈淡鞐愳劀 1靸� 鞛勳儊鞁滍棙鞚� 鞁滌瀾頃� 瓿勴殟鞛呺媹雼�.
IBI3032電� 霃欕摫 鞖╇焿 雽�牍� 瓴届焷 鞎诫氤措嫟 5~10氚� 雴掛潃 瓴疥惮 雲胳稖鞚� 雼劚頃橂┌ 鞖办垬頃� 鞝勳瀯靸� 瓴瓣臣毳� 氤挫榾鞀惦媹雼�. 鞚� 鞎诫鞚� GLP-1R KI DIO 靸濎鞕� 牍勲 鞗愳埈鞚� 氇嵏鞐愳劀 頄レ儊霅� 須姤瓿� 鞖办垬頃� 雮挫暯靹膘潉 雮橅儉雮措┌, 雿� 雮潃 鞖╇焿鞐愳劀霃� 鞙犾偓頃� 旃橂 須臣毳� 氤挫榾鞀惦媹雼�.
頄ロ泟 鞛勳儊鞁滍棙鞚� 瓯搓皶頃� 歆�鞗愳瀽鞕� 瓿检泊欷�/牍勲 彀戈岸撵瀽毳� 韽暔頃橂┌, 雼闺嚚氤�, 觳挫 甏�毽�, 瓿犿槇鞎� 氚� 韽愳噭靹� 靾橂┐ 氍错樃頋§(OSA) 旃橂毳� 氇╉憸搿� 頃╇媹雼�.
Innovent Biologics (IVBIY) a obtenu l'approbation de la FDA pour sa demande de nouveau m茅dicament exp茅rimental (IND) concernant IBI3032, un nouvel agoniste oral du r茅cepteur GLP-1. La soci茅t茅 pr茅voit de lancer des essais cliniques de phase 1 en Chine et aux 脡tats-Unis au cours du second semestre 2025.
IBI3032 a d茅montr茅 des r茅sultats pr茅cliniques sup茅rieurs, atteignant une exposition orale 5 脿 10 fois plus 茅lev茅e 脿 doses 茅quivalentes par rapport aux compos茅s concurrents. Le m茅dicament a montr茅 une meilleure efficacit茅 et une bonne tol茅rance chez des souris GLP-1R KI DIO et des mod猫les de singes ob猫ses, obtenant des effets th茅rapeutiques comparables 脿 des doses plus faibles.
Les prochains essais incluront des volontaires sains ainsi que des participants en surpoids/ob猫ses, ciblant des applications dans le diab猫te, la gestion du poids, l'hypertension et l'apn茅e obstructive du sommeil (AOS).
Innovent Biologics (IVBIY) hat die FDA-Zulassung f眉r seinen Antrag auf ein Investigational New Drug (IND) f眉r IBI3032, einen neuartigen oralen GLP-1-Rezeptoragonisten, erhalten. Das Unternehmen plant, in der zweiten H盲lfte des Jahres 2025 Phase-1-Studien sowohl in China als auch in den USA zu starten.
IBI3032 zeigte 眉berlegene pr盲klinische Ergebnisse mit 5- bis 10-fach h枚herer oraler Bioverf眉gbarkeit bei vergleichbaren Dosen im Vergleich zu Konkurrenzpr盲paraten. Das Medikament zeigte verbesserte Wirksamkeit und gute Vertr盲glichkeit in GLP-1R KI DIO-M盲usen und adip枚sen Affenmodellen und erzielte vergleichbare therapeutische Effekte bei niedrigeren Dosen.
Die kommenden Studien werden sowohl gesunde Freiwillige als auch 眉bergewichtige/adip枚se Teilnehmer einschlie脽en und zielen auf Anwendungen bei Diabetes, Gewichtsmanagement, Bluthochdruck und obstruktiver Schlafapnoe (OSA) ab.
- Achieved 5-10x higher oral exposure compared to peer compounds in preclinical studies
- Demonstrated improved efficacy and good tolerability in animal models
- Potential applications beyond diabetes/weight management, including hypertension and OSA
- Concurrent Phase 1 trials planned in both U.S. and China markets
- Early-stage development (Phase 1) with significant clinical trials still ahead
- Will face competition from established GLP-1 treatments in the market
IBI3032 is an orally administered small-molecule GLP-1 receptor agonist with bias for cAMP signaling pathway, discovered and developed by Innovent Biologics with proprietary rights. Preclinical data demonstrate its superior pharmacokinetic (PK) and physicochemical properties compared to peer compounds. In animal models, IBI3032 achieved 5 to 10 times higher oral exposure at equivalent doses, with improved efficacy and good tolerability in both GLP-1R KI DIO mice and obese monkey models, achieving comparable therapeutic effects at lower doses.
The Phase 1 clinical trials of IBI3032 are planned to be conducted concurrently in
Dr. Lei Qian, Chief R&D Officer for General Biomedicines Pipeline at Innovent Biologics, 蝉补颈诲,听"GLP-1 has emerged as a blockbuster target over the past decade. Its oral form, with its convenience, flexibility, and unique advantage in combination treatment strategies, holds promise as a differentiated complement to GLP-1R-targeting biologicals. Beyond traditional applications in diabetes and weight management, oral GLP-1 possess potential in treating related diseases such as hypertension and OSA (obstructive sleep apnea). IBI3032 has demonstrated its promising efficacy profiles in animal models, where IBI3032 exhibited a longer elimination half-life and higher drug exposure levels than its competitors at the same dose. We are excited to advance this candidate into clinical development. This IND approval reflects Innovent's strong R&D capabilities and, most importantly, our commitment to global innovation. We hope that in the near future, IBI3032 can offer more effective and convenient treatment options to benefit patients around the world. "
About IBI3032
IBI3032 is a novel oral small molecule glucagon-like peptide-1 receptor agonist (GLP-1RA). By efficiently and selectively targeting GLP-1R, it activates downstream signal transduction, thereby delaying gastric emptying, inhibiting appetite, and promoting insulin secretion, and ultimately supporting the treatment of insulin-related metabolic diseases such as obesity and T2DB. Discovered through a structure-based drug design (SBDD) strategy combined with systematic physicochemical property optimization, IBI3032 has shown better PK and physicochemical properties compared to similar compounds.
The IND application of IBI3032 was accepted by
About Innovent Biologics
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 16 products in the market. It has 2 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center.
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow聽Innovent on Facebook and LinkedIn.
Statement: |
锛�1锛�Innovent does not recommend the use of any unapproved drug (s)/indication (s). |
锛�2锛�Ramucirumab (Cyramza)锛�Selpercatinib (Retsevmo) and Jaypirca (pirtobrutinib) were developed by Eli Lilly and Company. |
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FAQ
What is the significance of Innovent's FDA IND approval for IBI3032?
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