This section highlights FDA-related milestones and regulatory updates for drugs developed by Evolus (EOLS).
Over the past two years, Evolus has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Evolysse™, Jeuveau, and Nuceiva®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Evolysse™ FDA Regulatory Timeline and Events
Evolysse™ is a drug developed by Evolus for the following indication: Evolus dermal filler.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Evolysse™
- Announced Date:
- August 25, 2025
- Indication:
- Evolus dermal filler,
Announcement
Evolus, Inc announced positive topline results from a U.S. pivotal study of Evolysse™ Sculpt, an injectable hyaluronic acid (HA) gel product designed to restore mid-face volume.
AI Summary
Evolus, Inc. announced positive topline results from its U.S. pivotal study of Evolysse™ Sculpt, an injectable hyaluronic acid gel designed to restore mid-face volume. The trial met its primary endpoint of non-inferiority and showed statistical superiority to Restylane®-Lyft at six months.
In the multi-center, double-blind study, 304 patients were randomized to receive either Evolysse™ Sculpt or Restylane®-Lyft. At the six-month mark, Evolysse™ Sculpt achieved a 90.9% responder rate versus 83.3% with Restylane®-Lyft, and the mean improvement in volume deficit was significantly greater (p < 0.001).
The safety profile of Evolysse™ Sculpt was similar to the control, with no treatment-related serious adverse events reported. Patients also noted high satisfaction and long-lasting, natural-looking results thanks to its Cold-X™ technology.
Evolus has submitted a Premarket Approval application to the U.S. Food and Drug Administration and expects approval in the second half of 2026.
Read Announcement- Drug:
- Evolysse™
- Announced Date:
- August 20, 2025
- Indication:
- Evolus dermal filler,
Announcement
Evolus, Inc. announced that it has submitted the final module of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Evolysse™ Sculpt, an injectable hyaluronic acid (HA) gel product designed to restore mid-face volume.
AI Summary
Evolus, Inc. announced it submitted the final module of its Premarket Approval application to the FDA for Evolysse™ Sculpt. Evolysse Sculpt is an injectable hyaluronic acid gel designed to restore mid-face volume. It is the most structured product in the Evolysse collection and uses a novel Cold-X™ technology to preserve the natural HA structure for long-lasting results. Sculpt is expected to become the flagship brand in the collection and will enter the highest-value segment of today’s dermal filler market. Evolus conducted a pivotal U.S. trial with 304 patients in a multicenter, double-blind, controlled study comparing Sculpt to a competitor. Patients were followed for 24 months to assess safety and effectiveness. The company expects the standard PMA review to conclude in the second half of 2026, pending FDA approval. This milestone highlights Evolus’s commitment to meeting rigorous regulatory requirements and expanding its aesthetic injectable portfolio.
Read Announcement- Drug:
- Evolysse™
- Announced Date:
- May 22, 2025
- Indication:
- Evolus dermal filler,
Announcement
Evolus, Inc. announced the publication of the U.S. pivotal study results for Evolysse™ Form and Evolysse™ Smooth in the Aesthetic Surgery Journal, a leading peer-reviewed journal focusing on advances in aesthetic medicine and surgery.
AI Summary
Evolus, Inc. announced that the U.S. pivotal study results for Evolysse™ Form and Evolysse™ Smooth have been published in the Aesthetic Surgery Journal, a respected peer-reviewed publication in aesthetic medicine and surgery. The study was a multicenter, randomized, controlled, double-blind trial including 140 patients over 12 months. It focused on the long-term safety and effectiveness of these Cold-X™ crosslinked injectable hyaluronic acid gels for correcting moderate to severe dynamic facial wrinkles and folds.
The published results demonstrated that both Evolysse™ products met the primary endpoint of non-inferiority and were statistically superior to a well-established control, Restylane®-L. Evolysse™ Form showed significant improvement at every time point, while Evolysse™ Smooth achieved statistically significant benefits at key intervals with a lower injection volume. These findings support the products’ durable aesthetic results and high patient satisfaction.
Read Announcement- Drug:
- Evolysse™
- Announced Date:
- February 13, 2025
- Indication:
- Evolus dermal filler,
Announcement
Evolus, Inc announced that the U.S. Food and Drug Administration (FDA) has approved Evolysse™ Form and Evolysse™ Smooth injectable hyaluronic acid (HA) gels, the first two products in the Evolysse™ collection.
AI Summary
Evolus, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Evolysse™ Form and Evolysse™ Smooth injectable hyaluronic acid (HA) gels. These products are the first in the Evolysse™ collection and mark a major breakthrough in HA dermal fillers, introducing a new standard in performance and innovation. The FDA approval confirms that both products are safe and effective, leveraging Cold-X™ technology to better preserve the natural structure of HA for long-lasting, natural-looking results. This development represents a key milestone in Evolus’ strategy to transition from a single-product company to a multi-product innovator in the aesthetic field. The company plans to launch these approved products in the U.S. in Q2 2025, providing healthcare practitioners with advanced options to address diverse patient needs in cosmetic treatments.
Read Announcement- Drug:
- Evolysse™
- Announced Date:
- June 24, 2024
- Indication:
- Evolus dermal filler,
Announcement
Evolus, Inc. announced that it has submitted the final module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Evolysse™ Lift and Evolysse™ Smooth dermal filler products for the nasolabial fold (NLF).
AI Summary
Evolus, Inc. has reached an important milestone by submitting the final module of its premarket approval (PMA) application to the U.S. Food and Drug Administration for its Evolysse™ Lift and Evolysse™ Smooth dermal filler products. These fillers are designed specifically to treat the nasolabial fold, a key area for facial rejuvenation. The submission marks a significant step forward for Evolus in meeting rigorous FDA regulatory requirements before the products can reach the market. The application includes data from a U.S. pivotal study that demonstrated the safety and efficacy of both products. During the study, patients received either Evolysse™ fillers or a control product in a split-face design to evaluate performance. This development underscores Evolus’ dedication to expanding its product portfolio and providing effective aesthetic solutions for consumers. The FDA review is expected to follow standard timelines with potential approval later in 2025.
Read Announcement- Drug:
- Evolysse™
- Announced Date:
- May 20, 2024
- Indication:
- Evolus dermal filler,
Announcement
Evolus, Inc. announced positive topline results from a U.S. pivotal nasolabial fold (NLF) study of dermal filler products Evolysse™ Lift and Smooth. Data were presented at the 2024 SCALE Meeting on May 17, 2024, in Nashville.
AI Summary
Evolus, Inc. announced positive topline results from a pivotal U.S. study evaluating its Evolysse™ Lift and Evolysse™ Smooth dermal fillers for improving nasolabial fold severity. The study was presented at the 2024 SCALE Meeting in Nashville on May 17, 2024, and used a blinded, split-face design comparing the new products to Restylane-L. Evolysse™ Lift met the primary endpoint of non-inferiority at six months and showed statistically significant superiority over Restylane-L at all assessment points from 6 weeks through 12 months. Similarly, Evolysse™ Smooth achieved non-inferiority and demonstrated superior performance at the 6- and 9-month marks compared to the control. Both products exhibited similar safety profiles with no treatment-related serious adverse events. These promising results support Evolus’ plan to submit FDA Premarket Approval applications for the Evolysse™ dermal fillers within the next 90 days, marking a significant step toward their U.S. launch.
Read Announcement
Jeuveau FDA Regulatory Events
Jeuveau is a drug developed by Evolus for the following indication: Aesthetics.
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:
- Jeuveau
- Announced Date:
- July 31, 2025
- Indication:
- Aesthetics
Announcement
Evolus, Inc. announced the publication of a landmark independent study in JAMA Dermatology directly comparing four leading botulinum toxin type A products for the treatment of glabellar lines: Jeuveau® (prabotulinumtoxinA-xvfs), Botox® (onabotulinumtoxinA), Dysport® (abobotulinumtoxinA), and Xeomin® (incobotulinumtoxinA).
AI Summary
Evolus, Inc. announced a landmark study published in JAMA Dermatology directly comparing four FDA-approved neurotoxins for glabellar lines: Jeuveau®, Botox®, Dysport®, and Xeomin®. In a double-blind, randomized trial at the University of Pennsylvania, 143 women aged 30–65 received standard doses of each product.
Using advanced 3D photogrammetry, researchers measured dynamic facial strain at days 3, 30, 90, and 180. Jeuveau® and Dysport® showed significantly faster visible effects at day 3 than Botox® and Xeomin®. At day 30, Jeuveau® achieved the strongest peak effect with a median 93% strain reduction. By day 180, Jeuveau® maintained a significant treatment effect from baseline and outperformed Botox® in duration.
The independently conducted study was funded by Evolus but designed and executed solely by investigators, eliminating potential bias. These results underscore Jeuveau®’s differentiated profile of fast onset, strong peak impact, and lasting benefits for aesthetic practice.
Read Announcement
Nuceiva® FDA Regulatory Events
Nuceiva® is a drug developed by Evolus for the following indication: For the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients2.
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:
- Nuceiva®
- Announced Date:
- July 9, 2025
- Indication:
- For the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients2.
Announcement
Evolus, Inc announced it has partnered with Symatese to commence distribution of Nuceiva® (botulinum toxin type A) in France.
AI Summary
Evolus, Inc. has announced a key expansion into France through a new partnership with Symatese to distribute its product Nuceiva® (botulinum toxin type A). Under this agreement, French medical aesthetics professionals can now order and receive Nuceiva®, a product approved by the European Commission for temporarily improving moderate to severe glabellar lines. This move marks an important step in Evolus’s strategy to grow its global presence and serve international markets. The partnership with Symatese, a well-established French company known for its strong relationships with local clinicians and expertise in medical devices, is expected to enhance the distribution and accessibility of Nuceiva® across France. With the product already recognized in the United States as Jeuveau®, this expansion positions Evolus to further tap into the growing demand for innovative, non-surgical aesthetic treatments.
Read Announcement- Drug:
- Nuceiva®
- Announced Date:
- July 30, 2024
- Indication:
- For the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients2.
Announcement
Evolus, Inc. a performance beauty company focused on building an aesthetic portfolio, has commenced operations in Australia with the launch of Nuceiva® (prabotulinumtoxinA).
AI Summary
Evolus, Inc., a performance beauty company focused on building an aesthetic portfolio, has kicked off operations in Australia with the launch of Nuceiva® (prabotulinumtoxinA). Nuceiva® is approved by Australia’s Therapeutic Goods Administration (TGA) for temporarily improving the appearance of moderate to severe glabellar lines in adults. This move marks an important step in Evolus’ strategy of geographic expansion and positions the firm to tap into a growing market for non-surgical cosmetic procedures.
The company has set up Evolus Australia to drive medical education, training, marketing, and sales among aesthetics healthcare professionals. Under the leadership of Daniel Henry, the dedicated local team will collaborate with practitioners to offer innovative treatments and continue Evolus’ global growth strategy in the competitive aesthetics industry.
Read Announcement
