Alaunos Therapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Alaunos Therapeutics (TCRT).
Over the past two years, Alaunos Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ALN1003. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ALN1003 FDA Regulatory Timeline and Events
ALN1003 is a drug developed by Alaunos Therapeutics for the following indication: Non-Hormonal Oral Treatment for Obesity and Related Metabolic Disorders.
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.
- Drug:
- ALN1003
- Announced Date:
- May 26, 2026
- Indication:
- Non-Hormonal Oral Treatment for Obesity and Related Metabolic Disorders
Announcement
Alaunos Therapeutics, Inc. today reported an integrated preclinical readout for ALN1003, the Company's investigational oral, non-hormonal, non-incretin small-molecule candidate for obesity and related metabolic disorders.
AI Summary
Alaunos Therapeutics said its preclinical studies of ALN1003, an oral non-hormonal, non-incretin small-molecule candidate for obesity and related metabolic disorders, showed encouraging effects across several signs of metabolic disease. In diet-induced obesity mouse studies, the drug was linked to lower body weight and food intake, improved body composition, and better insulin-resistance markers. One study also found lower fasting insulin and HOMA-IR, plus healthier adipose signals, including higher adiponectin and a better adiponectin-to-leptin ratio.
In a second study, the high-dose group showed lower blood glucose and lower total cholesterol than obese controls. The company said these results suggest ALN1003 may affect several drivers of metabolic dysfunction, including insulin resistance, fat tissue signaling, and liver fat buildup. Alaunos plans more preclinical work, manufacturing activities, and formulation studies to better define dosing, safety, and how the drug works.
Read Announcement- Drug:
- ALN1003
- Announced Date:
- May 18, 2026
- Indication:
- Non-Hormonal Oral Treatment for Obesity and Related Metabolic Disorders
Announcement
Alaunos Therapeutics, Inc. announced updated preclinical data from non-GLP diet-induced obesity (DIO) mouse studies evaluating ALN1003, the Company's investigational oral metabolic therapeutic candidate.
AI Summary
Alaunos Therapeutics said its updated preclinical data from non-GLP diet-induced obesity (DIO) mouse studies support further development of ALN1003, an oral metabolic drug candidate. The results suggest the compound may affect several key drivers of metabolic dysfunction, including insulin resistance, fat tissue signaling, and liver lipid metabolism. The company said ALN1003 could have potential use in metabolic syndrome and related disorders.
To build on these findings, Alaunos plans more preclinical testing focused on finding the best dose, understanding exposure-response relationships, expanding metabolic measurements, and studying liver damage and the biological pathways involved. The company also noted that it has limited cash and expects its current runway to last into the second quarter of 2026, so it plans to seek additional financing to continue its obesity and metabolic disorders program.
Read Announcement- Drug:
- ALN1003
- Announced Date:
- March 2, 2026
- Indication:
- Non-Hormonal Oral Treatment for Obesity and Related Metabolic Disorders
Announcement
Alaunos Therapeutics, Inc. announced early data from two non-Good Laboratory Practice (non-GLP) diet-induced obesity (DIO) mouse studies evaluating ALN1003, the Company's lead small-molecule drug candidate for treating obesity and related conditions, such as metabolic dysfunction-associated steatotic liver disease (MASLD, a type of fatty liver disease).
AI Summary
Alaunos Therapeutics reported early, non‑GLP data from two diet‑induced obesity (DIO) mouse studies of ALN1003, its oral small‑molecule candidate for obesity and related metabolic disease. In Study 1, ALN1003-treated mice showed peak mean weight loss of –12.9% (p<0.0001) on Day 34 and –10.3% (p<0.0001) at Day 48 versus DIO controls. Treated mice ate less overall (347.5 g vs 425.0 g per cage; nominal p<0.05). Study 2 body-composition analysis showed dose-related losses driven mainly by fat but also by lean and fluid mass. At the highest dose, mice had lower blood glucose (197 vs 320 mg/dL; p<0.0001) and lower total cholesterol (162 vs 209 mg/dL; nominal p<0.05); HDL also fell (nominal p<0.05).
Tolerability was generally acceptable, with transient, mild hypolocomotion after dosing in Study 1 and two slightly dehydrated high‑dose mice in Study 2. The company noted that drug‑related loss of appetite and thirst may have reduced drinking of medicated water, which can confound weight‑loss attribution. These early results will guide ongoing preclinical work and CMC development.Read Announcement
Alaunos Therapeutics FDA Events - Frequently Asked Questions
As of now, Alaunos Therapeutics (TCRT) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Alaunos Therapeutics (TCRT) has reported FDA regulatory activity for ALN1003.
The most recent FDA-related event for Alaunos Therapeutics occurred on May 26, 2026, involving ALN1003. The update was categorized as "Provided Update," with the company reporting: "Alaunos Therapeutics, Inc. today reported an integrated preclinical readout for ALN1003, the Company's investigational oral, non-hormonal, non-incretin small-molecule candidate for obesity and related metabolic disorders."
Currently, Alaunos Therapeutics has one therapy (ALN1003) targeting the following condition: Non-Hormonal Oral Treatment for Obesity and Related Metabolic Disorders.
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Companies With Recent 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
FDA progress for NASDAQ:TCRT last updated on 5/27/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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