This section highlights FDA-related milestones and regulatory updates for drugs developed by PMGC (ELAB).
Over the past two years, PMGC has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
EL-22, Elevai, Elevai, and Y100™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
EL-22 - FDA Regulatory Timeline and Events
EL-22 is a drug developed by PMGC for the following indication: In the treatment of obesity and muscle loss preservation.
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:
- EL-22
- Announced Date:
- May 22, 2025
- Indication:
- In the treatment of obesity and muscle loss preservation.
Announcement
Northstrive Biosciences Inc announced the completion of a Phase I strategic research and literature synthesis for EL-22 (formerly BLS-M22), its first-in-class oral myostatin-engineered probiotic.
AI Summary
Northstrive Biosciences Inc., a subsidiary of PMGC Holdings Inc., announced the successful completion of a Phase I strategic research and literature synthesis for EL-22 (formerly BLS-M22). EL-22 is a first-in-class oral myostatin‐engineered probiotic that targets muscle-wasting conditions.
The study, conducted in collaboration with Yuva Biosciences and supported by their AI-based MitoNova™ technology, provided key insights into EL-22’s mechanism of action. This unique oral vaccine uses genetically engineered Lactobacillus casei to stimulate both mucosal and systemic immunity by inducing an immune response against myostatin, a protein that limits muscle growth.
The findings lay the groundwork for further exploration into how EL-22 can potentially help address critical muscle loss issues, such as those associated with GLP-1 receptor agonist treatments and age-related sarcopenia.
Read Announcement- Drug:
- EL-22
- Announced Date:
- April 29, 2025
- Indication:
- In the treatment of obesity and muscle loss preservation.
Announcement
Northstrive Biiary of PMGC Hosciences Inc. ("Northstrive"), a subsidoldings Inc. announced the filing of four novel patent applications for its two candidates EL-22 and EL-32.
AI Summary
Northstrive Biosciences Inc., a subsidiary of PMGC Holdings Inc., recently filed four new patent applications for its two promising drug candidates, EL-22 and EL-32. These filings cover innovative uses in both human and animal health. The patents for EL-22 focus on a fusion protein of Myo-2 designed to promote muscle growth in animals and potentially treat muscle loss in obese patients.
For EL-32, Northstrive has submitted applications that detail its use as a standalone treatment and in combination with GLP-1 receptor agonists to address muscle loss during obesity treatments. Additionally, one of the EL-32 patents explores its application as an animal feed additive to encourage muscle growth. These filings aim to secure a strong intellectual property portfolio while supporting Northstrive’s efforts to advance its engineered probiotic platform for obesity care and animal health solutions.
Read Announcement- Drug:
- EL-22
- Announced Date:
- April 24, 2025
- Indication:
- In the treatment of obesity and muscle loss preservation.
Announcement
Northstrive Biosciences Inc. a subsidiary of PMGC Holdings Inc. announced that it has received preliminary responses and commentary from the U.S. Food and Drug Administration ("FDA") regarding its scheduled Type B pre-Investigational New Drug ("pre-IND") meeting.
AI Summary
Northstrive Biosciences Inc., a subsidiary of PMGC Holdings Inc., recently received preliminary responses from the U.S. Food and Drug Administration (FDA) regarding its scheduled Type B pre-Investigational New Drug (pre-IND) meeting. During this meeting, the company planned to discuss its nonclinical studies and clinical development plans for EL-22, a novel drug used in combination with GLP-1 receptor agonists to help maintain muscle mass in overweight or obese patients.
The FDA’s initial feedback was positive, indicating that the nonclinical studies provided adequate evidence of the safety and activity of EL-22 in the target population. Based on this favorable response, Northstrive believes the current data supports the next steps and intends to move forward by filing an IND application to begin a Phase 2 clinical trial later this year.
Read Announcement- Drug:
- EL-22
- Announced Date:
- March 10, 2025
- Indication:
- In the treatment of obesity and muscle loss preservation.
Announcement
Northstrive Biosciences Inc announced that it has scheduled a pre-Investigational New Drug ("pre-IND") meeting with the U.S. Food and Drug Administration ("FDA") for Wednesday, April 23, 2025.
AI Summary
Northstrive Biosciences Inc. has set a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for Wednesday, April 23, 2025. This Type B meeting will focus on the future development and regulatory path for EL-22, an engineered probiotic designed to display myostatin on its surface. The company aims to file an IND for using EL-22 in combination with GLP-1 receptor agonists, a treatment approach intended to preserve muscle during weight loss for individuals with obesity.
The pre-IND meeting is considered a key step in advancing EL-22 towards human trials. Northstrive expects that the discussion with the FDA will provide a clear roadmap for further clinical development of this innovative therapy. The company is committed to addressing one of obesity’s major challenges by offering a potential new option to help maintain muscle health while supporting weight loss efforts.
Read Announcement- Drug:
- EL-22
- Announced Date:
- February 18, 2025
- Indication:
- In the treatment of obesity and muscle loss preservation.
Announcement
Northstrive Biosciences, a subsidiary of PMGC Holdings Inc. announced the submission of a pre-IND meeting request to the FDA.
AI Summary
Northstrive Biosciences, a subsidiary of PMGC Holdings Inc., has taken a key step by submitting a pre-Investigational New Drug (pre‑IND) meeting request to the U.S. FDA for its novel asset, EL‑22. The asset is designed to preserve muscle during weight loss treatments and is intended to be used in combination with GLP‑1 receptor agonists for overweight or obese patients. The company is seeking the FDA’s guidance on the acceptability of its nonclinical studies and its overall clinical development plans. If the FDA’s response is favorable, a Type B pre‑IND meeting is expected to take place in the second quarter of 2025. This meeting will help outline the regulatory path forward for EL‑22 and set the stage for filing an Investigational New Drug application later in the year.
Read Announcement- Drug:
- EL-22
- Announced Date:
- February 18, 2025
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 - 2025
- Indication:
- In the treatment of obesity and muscle loss preservation.
Announcement
Northstrive anticipates having a Type B pre-IND meeting with the FDA in the second fiscal quarter of 2025.
AI Summary
Northstrive Biosciences has filed a pre-Investigational New Drug meeting request with the FDA for its novel myostatin asset, EL-22. The company plans to use the meeting to discuss its nonclinical studies and clinical development strategy for EL-22, which is intended to help maintain muscle mass during weight loss treatments that include GLP-1 receptor agonists.
Northstrive anticipates having a Type B pre-IND meeting with the FDA in the second fiscal quarter of 2025. The FDA is expected to respond to the meeting request in the first fiscal quarter of 2025, which would allow Northstrive to schedule the meeting in Q2 2025. This meeting is seen as a key step in finalizing the regulatory plans and coordinating necessary manufacturing preparations for the upcoming Investigational New Drug application.
Read Announcement- Drug:
- EL-22
- Announced Date:
- December 9, 2024
- Indication:
- In the treatment of obesity and muscle loss preservation.
Announcement
Elevai Labs announced the next steps in its regulatory strategy for EL-22, aimed at treating obesity and preserving muscle mass.
AI Summary
Elevai Labs has outlined its new regulatory strategy for EL-22, a first-in-class myostatin asset developed to treat obesity while preserving muscle mass. The company is preparing for a pre-Investigational New Drug (IND) meeting with the FDA, scheduled for the first quarter of 2025. This meeting will help clarify any extra preclinical requirements and adjustments needed for Chemistry, Manufacturing, and Controls before they officially file the IND application.
EL-22 is designed to work in combination with GLP-1 receptor agonists to address a common issue found in rapid weight loss treatments—muscle loss. Using an engineered probiotic that expresses myostatin, EL-22 aims to support muscle health during weight reduction. The promising preclinical results and safety data from a Phase 1 trial in South Korea provide a strong foundation for the next phase of clinical development in the United States.
Read Announcement
Elevai Enfinity™ - FDA Regulatory Timeline and Events
Elevai Enfinity™ is a drug developed by PMGC for the following indication: Topical Exosome Serum.
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:
- Elevai Enfinity™
- Announced Date:
- August 26, 2024
- Indication:
- Topical Exosome Serum
Announcement
Elevai Labs, Inc. announces the completion of a clinical study examining the effectiveness of Elevai exosomes on facial appearance.
AI Summary
Elevai Labs, Inc. announced that it has completed a clinical study on its Elevai enfinity™ topical exosome serum, which focuses on facial appearance. The study involved 29 participants aged 40 to 70 who had mild to moderate facial photoaging and sensitive skin. Over a 12‐week period, participants applied the serum twice daily. The study measured improvements in facial firmness, skin tone, wrinkle reduction, and overall smoothness. Results from the internal review show that the treatment is safe, tolerable, and produces significant improvements in various skin appearance aspects. Guided by board-certified dermatologist Dr. Zoe Draelos, the study highlights the potential of next-generation stem cell exosome technology in enhancing skin appearance. Elevai plans to publish the full findings in the near future after the study data undergoes peer review, marking a key step in validating this innovative approach to skincare.
Read Announcement
Elevai Exosomes™ - FDA Regulatory Timeline and Events
Elevai Exosomes™ is a drug developed by PMGC for the following indication: In hair restoration.
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:
- Elevai Exosomes™
- Announced Date:
- October 2, 2024
- Indication:
- In hair restoration
Announcement
Elevai Labs, Inc. announced the initiation of a clinical study to assess the efficacy of a topical exosome product in conjunction with an energy device treatment on facial skin appearance.
AI Summary
Elevai Labs, Inc. has launched a clinical study to evaluate the effectiveness of a new topical exosome product when paired with energy device treatments for facial skin rejuvenation. The study will test two formulations—Elevai empower™ for in-office use and Elevai enfinity™ for daily at-home application—to see if they improve the appearance of facial skin when used on their own and with energy-based treatments. Participants, aged 35 to 75 with mild to moderate signs of aging and various skin sensitivities, will apply the product daily over a 12-week period. The trial aims to assess safety, tolerability, and overall enhancement of facial appearance by comparing baseline data to results at the end of the study. Elevai is collaborating with renowned aesthetic medicine expert Dr. Jennifer Pearlman, and initial data is expected by Q1 2025.
Read Announcement- Drug:
- Elevai Exosomes™
- Announced Date:
- September 3, 2024
- Indication:
- In hair restoration
Announcement
Elevai Labs, Inc. announced data results from an on-going research study conducted in partnership with Carly Klein, President of the National Hair Loss Medical Aesthetics ("NHLMA"), demonstrating the potential of its proprietary Elevai Exosomes™ in hair restoration.
AI Summary
Elevai Labs, Inc. has shared promising data from an ongoing research study conducted with Carly Klein, President of the National Hair Loss Medical Aesthetics (NHLMA). This study explored the effects of Elevai’s proprietary Elevai Exosomes™ on individuals experiencing hair loss and thinning. Participants received an in-office treatment that included scalp microneedling followed by the application of an exosome serum, with subsequent at-home use of a complementary exosome product. The imaging analysis over up to 12 months showed that the treatment helped reduce inflammation on the crown, reversed the miniaturization of hairs, and reactivated dormant hair follicles. These results suggest that Elevai Exosomes™ may play a significant role in restoring hair and promoting scalp vitality. The study supports further research into combining exosome and mitochondrial technologies as part of the new Elevai S-Series Root Renewal System™, advancing options for hair restoration treatments.
Read Announcement
Y100™ - FDA Regulatory Timeline and Events
Y100™ is a drug developed by PMGC for the following indication: In Hair and Scalp Care Technology.
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:
- Y100™
- Announced Date:
- August 28, 2024
- Indication:
- In Hair and Scalp Care Technology
Announcement
Elevai Labs, Inc. announces the filing of two innovative patents in collaboration with Yuva Biosciences.
AI Summary
Elevai Labs, Inc. recently announced the filing of two new patents in collaboration with Yuva Biosciences. The first patent, titled “COMPOSITIONS AND METHODS FOR THE TREATMENT OF SKIN, SCALP, AND HAIR IMPROVEMENT,” covers a unique blend of Elevai’s exosomes and Yuva’s Y100 mitochondrial technology. This combination aims to give better results for hair and scalp health by delivering a synergistic effect. The second patent, “PREPARATIONS INCLUDING LIPID BILAYER NANOPARTICLES,” focuses on using exosomes and similar nanovesicles as a protective delivery system for key molecules.
This collaboration supports the development of Elevai’s new S-Series Root Renewal System™, designed to address hair thinning and aging at the cellular level. Leaders in the field, including BosleyMD®, have recognized the Y100 technology as a significant innovation in hair loss treatment, marking a promising step forward in medical aesthetics.
Read Announcement
