Is Profhilo FDA-Approved in the United States?

At a glance

Is Profhilo FDA-approved? No. No PMA, 510(k) or De Novo record for "Profhilo" (openFDA device data, last updated Sept. 28, 2026; FDA De Novo database, checked Oct. 12, 2026).

What does IBSA have approved in the U.S.? Only intra-articular hyaluronic acid knee products (SINOVIAL/GELSYN-3, PMA P110005) in FDA's PMA data, plus one 2002 510(k) for a wound dressing; nothing named Profhilo.

Is approval pending? No FDA decision is public. Evolus licensed U.S. rights on July 7, 2026, and forecasts U.S. commercialization in 2030 (Evolus, Aug. 5, 2026).

Is there a U.S. clinical trial? None listed with a U.S. site on ClinicalTrials.gov as of Oct. 12, 2026; listed Profhilo studies are in Italy, France and Poland.

What is Profhilo? Per IBSA, an injectable made from high- and low-molecular-weight hyaluronic acid using a patented heat process instead of chemical cross-linkers (manufacturer description).

Is any HA "skin booster" FDA-approved? Yes, at least one: FDA approved SKINVIVE by JUVÉDERM (Allergan) on May 11, 2023, to improve facial skin smoothness of the cheeks in adults over 21 (PMA P110033/S059).

What should I ask? The product's exact name, whether it is FDA-approved for the area being treated, and to see the packaging and patient labeling.

What FDA's records show

FDA regulates injectable hyaluronic acid (HA) fillers as medical devices. Its dermal filler page describes them as "medical device implants approved by the FDA" for specific uses. For high-risk (Class III) devices, FDA says "the applicant must receive FDA approval of its PMA application prior to marketing the device." Here is what we found on October 12, 2026:

Premarket approval (PMA): no record with "Profhilo" in any field in FDA's PMA data (via openFDA, FDA's public data API; data last updated September 28, 2026). IBSA Institut Biochimique SA's PMA records are all for P110005, intra-articular hyaluronic acid products sold as SINOVIAL and GELSYN-3 (orthopedic use, first approved May 9, 2014; latest supplement July 24, 2026).

510(k) clearance: no record with "Profhilo." IBSA's one 510(k), K020041 (March 14, 2002), is a hydrocolloid dressing.

De Novo: FDA's De Novo database returned "No records were found with Device Name: profhilo."

Dermal fillers for the face: FDA says approved facial fillers can be found in its PMA database under product code LMH. In FDA's data, the LMH applicants include Allergan, Q-Med, Merz, Teoxane, Prollenium, Croma-Pharma and others, but not IBSA or Evolus.

Registration, listing and device identifiers: no "Profhilo" entry in FDA's establishment registration and listing data or its GUDID device-identifier data.

Note on method: FDA's interactive PMA and 510(k) search pages on accessdata.fda.gov returned a bot-check page to our automated request, so we read the same FDA device data through openFDA. FDA's databases can change. We will re-check on any update.

Is approval coming?

Evolus, Inc. and IBSA signed a License, Supply and Distribution Agreement on July 7, 2026 (Evolus Form 8-K). Under it, Evolus is responsible "for U.S. development, clinical and regulatory activities intended to support U.S. Food and Drug Administration ('FDA') approval" and "will hold any resulting U.S. regulatory approval." The agreement's initial term is 15 years "from the first FDA approval."

In its August 5, 2026 second-quarter results, Evolus cited "Anticipated U.S. Commercialization in 2030." That is the company's forecast, not an FDA timeline.

IBSA's own July 28, 2026 announcement says Evolus "will complete the product's clinical development in accordance with current US regulations, which are necessary for ... the FDA ... to grant authorisation." These are company statements about plans. FDA has published no approval, and none of these documents names a U.S. study start date.

U.S. trials: On ClinicalTrials.gov (searched October 12, 2026), the Profhilo studies list sites only in Italy, France and Poland. The newest, NCT06719154 (Profhilo Structura, sponsored by IBSA Farmaceutici Italia), lists sites in France and Poland. FDA does not publish investigational device exemptions (IDEs), which FDA says allow an investigational device "to be used in a clinical study in order to collect safety and effectiveness data." So no listed U.S. trial doesn't mean none is planned.

What is Profhilo?

These are the maker's and its U.S. licensee's descriptions, not FDA findings:

IBSA says that in 2015 it patented "a thermal process that combines high and low molecular weight hyaluronic acid chains, without using chemical reagents," which it calls NAHYCO Hybrid Technology, and that the resulting complexes are "100% free from cross-linking chemical agents." IBSA markets Profhilo for what it calls "bioremodeling."

Evolus describes Profhilo as "an injectable hyaluronic acid product for skin-quality applications" (8-K) with "availability in more than 70 countries" and "more than 4.8 million treatments administered worldwide since its launch in 2015" (July 8, 2026 release). It says Profhilo is "intended for superficial application to improve overall skin quality" rather than "to restore volume, contour, or facial structure."

How well it works is a separate question from FDA status, and this page doesn't cover it. FDA has not reviewed Profhilo's safety or effectiveness for U.S. approval.

What "not FDA-approved" means for you

From FDA's dermal filler pages (current as of July 6, 2023 and November 9, 2020):

FDA says "the risks associated with unapproved uses of dermal fillers, or with the use of unapproved products are not known."

FDA tells patients: "Do not purchase dermal filler products online, because they could be counterfeit products or products that are not approved for use in the U.S." and "Do not inject yourself with dermal fillers."

FDA has warned about unapproved versions of a well-known filler brand being "sold and distributed in the U.S., including by online retailers," saying "the safety and effectiveness of these products cannot be assured." That warning was about specific Juvéderm products, not Profhilo, but it shows how FDA treats unapproved versions of products sold elsewhere.

FDA says approved fillers are approved "for use in specific areas of the face and hands," and lists injecting the neck among filler uses "not approved by the FDA." Ask what area a product is approved for.

FDA says the most serious filler risk is accidental injection into a blood vessel, which can cause tissue death, vision problems including blindness, and stroke. It says to seek immediate care for unusual pain, vision changes, or white, gray or blue skin near the injection site.

Questions to ask before any "skin booster"

From FDA's patient guidance:

1. What is the exact product, and is it FDA-approved for this area? FDA says to "read and discuss the patient labeling for the specific filler you are receiving." 2. What training and experience do you have? FDA recommends "a licensed health care provider with experience in the fields of dermatology or plastic surgery" and says to ask about training and experience injecting fillers. 3. What are the risks at this injection site? FDA says to talk about "injection sites and the risks associated with the procedure at each site."

Other questions to ask (ours, not FDA's): Can I see the box and lot number? Where was the product bought? If I'm told it's "Profhilo," how is it being used in the U.S. without FDA approval? Who do I call if I have a reaction?

If something goes wrong

FDA asks patients and health care providers to report problems with FDA-regulated products to MedWatch, FDA's safety information and adverse event reporting program, online or at 1-800-FDA-1088.

Find a physician

Find a Doctor

Dermatology doctors

Dr. Dhaval Bhanusali — board-certified dermatologist, New York; founder of Hudson Dermatology & Laser Surgery in Hudson Yards; medical dermatology, cosmetic dermatology, laser surgery and hair restoration per his profile

Dr. Lisa Airan — board-certified cosmetic dermatologist in Manhattan; per her profile, injectables including Botox and dermal fillers (Restylane, Radiesse, JUVÉDERM), laser treatments and skin-tightening technologies, plus medical dermatology

Neither profile lists Profhilo or skin boosters. We link them as board-certified dermatologists you can ask about FDA-approved options for skin quality. Ask any physician what product they use, and ask the questions above.

Related Haute MD pages

Are Exosomes FDA-Approved for Aesthetic Use?

What Are Dermal Fillers?

How Long Do Fillers Last?

Questions to Ask an Aesthetic Physician

What Questions Should I Ask Before Botox or Fillers?

Dermal Fillers — Medical Questions Answered

Aesthetics & Wellness Guides

Sources

openFDA device PMA data, FDA public data API (data last updated September 28, 2026): searches for "profhilo" (all fields), applicant "IBSA," applicant "Evolus," product code LMH

openFDA device endpoints (510(k), registration & listing, UDI, classification, enforcement): "profhilo" (no matches); 510(k) applicant IBSA (K020041, March 14, 2002)

openFDA PMA record P110033/S059 (Allergan, SKINVIVE by JUVÉDERM, decision May 11, 2023, product code LMH)

FDA De Novo database, device name "profhilo": no records (page updated October 12, 2026)

Dermal Fillers (Soft Tissue Fillers), FDA (content current as of July 6, 2023)

FDA-Approved Dermal Fillers, FDA (content current as of November 9, 2020)

Premarket Approval (PMA), FDA (content current as of May 16, 2019)

Investigational Device Exemption (IDE), FDA (content current as of August 22, 2024)

ClinicalTrials.gov search: Profhilo and NCT06719154, searched October 12, 2026

Evolus, Inc. Form 8-K, agreement dated July 7, 2026 (company filing)

Evolus press release, July 8, 2026 (company statement)

Evolus Q2 2026 results, Exhibit 99.1, August 5, 2026 (company statement; "Anticipated U.S. Commercialization in 2030")

IBSA announcement of Evolus agreement, July 28, 2026 (manufacturer statement)

Nahyco Hybrid Technology, IBSA Derma (manufacturer description)

All accessed October 12, 2026. FDA pages and databases can change. This article is general information, not medical advice. Haute MD is an editorial directory and does not provide medical advice. Consult a qualified physician for medical decisions.