Kailera Therapeutics (KLRA) FDA Approvals $11.53 +0.54 (+4.91%) As of 10:52 AM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsInsider TradesNews and TrendsOwnershipSEC FilingsShort Interest Kailera Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Kailera Therapeutics (KLRA). Over the past two years, Kailera Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as KAI-9531. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. KAI-9531 FDA Regulatory Events KAI-9531 is a drug developed by Kailera Therapeutics for the following indication: for the treatment of people living with obesity or overweight. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Enrollment Update - September 30,2026Enrollment Update Drug: KAI-9531Announced Date: September 30, 2026Indication: for the treatment of people living with obesity or overweight.AnnouncementKailera Therapeutics, Inc. announced the completion of enrollment in the KaiNETIC global Phase 3 clinical program. The KaiNETIC program, which encompasses three trials – KaiNETIC-1, KaiNETIC-2, and KaiNETIC-3 – is evaluating ribupatide injection (also known as KAI-9531), an investigational once-weekly dual GLP-1/GIP receptor agonist peptide, for the treatment of people living with obesity or overweight.Read Announcement Kailera Therapeutics FDA Events - Frequently Asked Questions Has Kailera Therapeutics received FDA approval? As of now, Kailera Therapeutics (KLRA) has not received any FDA approvals for its therapy in the last two years. What drugs has Kailera Therapeutics submitted to the FDA? In the past two years, Kailera Therapeutics (KLRA) has reported FDA regulatory activity for KAI-9531. What is the most recent FDA event for Kailera Therapeutics? The most recent FDA-related event for Kailera Therapeutics occurred on September 30, 2026, involving KAI-9531. The update was categorized as "Enrollment Update," with the company reporting: "Kailera Therapeutics, Inc. announced the completion of enrollment in the KaiNETIC global Phase 3 clinical program. The KaiNETIC program, which encompasses three trials – KaiNETIC-1, KaiNETIC-2, and KaiNETIC-3 – is evaluating ribupatide injection (also known as KAI-9531), an investigational once-weekly dual GLP-1/GIP receptor agonist peptide, for the treatment of people living with obesity or overweight." What conditions do Kailera Therapeutics' current drugs treat? Currently, Kailera Therapeutics has one therapy (KAI-9531) targeting the following condition: for the treatment of people living with obesity or overweight.. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events ANI Pharmaceuticals FDA EventsCandel Therapeutics FDA EventsCelcuity FDA EventsConnect Biopharma FDA EventsCytosorbents FDA EventsDiaMedica Therapeutics FDA EventsEupraxia Pharmaceuticals FDA EventsJade Biosciences FDA EventsKailera Therapeutics FDA EventsSatellos Bioscience FDA EventsQ32 Bio FDA EventsSol-Gel Technologies FDA EventsSilexion Therapeutics FDA EventsSarepta Therapeutics FDA EventsTiziana Life Sciences FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Cogent Biosciences FDA Events Travere Therapeutics FDA Events Oruka Therapeutics FDA Events CRISPR Therapeutics FDA Events PTC Therapeutics FDA Events Grifols FDA Events Erasca FDA Events Iovance Biotherapeutics FDA Events Edgewise Therapeutics FDA Events Tango Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:KLRA last updated on 9/30/2026 by MarketBeat.com Staff. 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Enrollment Update - September 30,2026Enrollment Update Drug: KAI-9531Announced Date: September 30, 2026Indication: for the treatment of people living with obesity or overweight.AnnouncementKailera Therapeutics, Inc. announced the completion of enrollment in the KaiNETIC global Phase 3 clinical program. The KaiNETIC program, which encompasses three trials – KaiNETIC-1, KaiNETIC-2, and KaiNETIC-3 – is evaluating ribupatide injection (also known as KAI-9531), an investigational once-weekly dual GLP-1/GIP receptor agonist peptide, for the treatment of people living with obesity or overweight.Read Announcement
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