Biofrontera (BFRA) FDA Approvals

Biofrontera's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Biofrontera (BFRA). Over the past two years, Biofrontera has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Ameluz. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Ameluz FDA Regulatory Timeline and Events

Ameluz is a drug developed by Biofrontera for the following indication: For treatment of actinic keratosis. 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.

evaluation - August 25,2025

Phase 2b

• Drug: Ameluz
• Announced Date: August 25, 2025
• Indication: For treatment of actinic keratosis

Biofrontera Inc. announced that the final patient in its Phase 2b clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris (AV) completed participation on August 22, 2025.

Biofrontera Inc. announced that the final patient in its Phase 2b clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for moderate to severe acne vulgaris completed participation on August 22, 2025. The company expects to report top-line results in the first quarter of 2026 and plans to meet with the U.S. Food and Drug Administration in the third quarter of 2026 to discuss a Phase 3 program and potential label expansion.

The multicenter, randomized, double-blind study compares Ameluz® gel to a vehicle gel using red-light photodynamic therapy. Participants applied one tube of gel to the entire face, waited one or three hours before illumination with the BF-RhodoLED® lamp, and received up to three monthly treatment sessions. They were monitored for two months after their final session to assess safety and effectiveness.

Acne vulgaris affects about 50 million people in the U.S. each year and can cause permanent scarring, low self-esteem, and depression. Current treatments—topical agents, oral antibiotics, hormonal therapies, and isotretinoin—often carry side effects, teratogenic risks, or antibiotic resistance concerns. A successful Phase 2b outcome could offer patients a safer, more effective alternative.

Provided Update - June 3,2025

• Drug: Ameluz
• Announced Date: June 3, 2025
• Indication: For treatment of actinic keratosis

Biofrontera announced the inclusion of the patent for its propylene glycol-free formulation of Ameluz® nanoemulsion gel in the US Food and Drug Administration's (FDA's) publication "Approved Drug Products with Therapeutic Equivalence Evaluations" (commonly known as the Orange Book).

Biofrontera announced that the US FDA has included the patent for its propylene glycol-free formulation of Ameluz® nanoemulsion gel in the Orange Book. This inclusion confirms that the revised formulation meets the FDA’s high standards for safety, effectiveness, and quality. By eliminating propylene glycol, a known allergen, the new formulation offers a promising option for patients who are sensitive to this ingredient. The listing in the Orange Book provides significant intellectual property protection until December 2043 and helps prevent generic competition. Healthcare providers, pharmacists, and payers can now refer to the Orange Book for detailed information on this FDA-approved drug, ensuring that its status and patented attributes are clear in the market. Biofrontera’s announcement highlights its commitment to innovative, patient-focused treatment options in photodynamic therapy while maintaining strict adherence to regulatory standards.

Enrollment Completion - May 15,2025

• Drug: Ameluz
• Announced Date: May 15, 2025
• Indication: For treatment of actinic keratosis

Biofrontera Inc. announced the successful enrollment of the final patient in its Phase 2b clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris.

Biofrontera Inc. has announced a significant milestone in expanding its treatment options for moderate to severe acne vulgaris. The company has successfully enrolled the final patient in its Phase 2b clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride). This multicenter, randomized, double-blind study aims to assess the safety and effectiveness of photodynamic therapy (PDT) using the BF-RhodoLED® lamp alongside Ameluz®. In the trial, 120 patients receive either Ameluz® or a placebo gel with two different incubation periods followed by a 10 minute illumination session. Each patient can receive up to three treatment sessions with subsequent follow-up consultations. The results of this study may pave the way for a new, effective treatment alternative for acne, offering hope to millions of Americans experiencing this common skin condition.

Enrollment Update - March 18,2025

Phase 3

• Drug: Ameluz
• Announced Date: March 18, 2025
• Indication: For treatment of actinic keratosis

Biofrontera Inc. announced the enrollment of the final patient in its Phase 3 clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck and trunk.

Biofrontera Inc. has announced that the final patient has been enrolled in its Phase 3 clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for treating mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk. This study is testing the use of photodynamic therapy (PDT) with Ameluz® compared to a vehicle gel. In the trial, patients receive one treatment and may receive a second treatment at 12 weeks if any AK lesions remain. The total product applied can range between 1 to 3 tubes over a surface area of up to 240 cm². This enrollment milestone is a key step as the company works toward offering a new treatment option for AKs beyond the face and scalp, potentially addressing a critical unmet need in dermatology.

Provided Update - October 7,2024

• Drug: Ameluz
• Announced Date: October 7, 2024
• Indication: For treatment of actinic keratosis

Biofrontera Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company's sNDA to increase the maximally approved dosage from one to three tubes of Ameluz® per treatment.

Biofrontera Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) to raise the maximum approved dosage for Ameluz® from one tube to three tubes per treatment. This update allows healthcare professionals to treat larger areas of actinic keratosis (AK) on the face and scalp with photodynamic therapy (PDT), offering enhanced flexibility when addressing patients with multiple or extensive lesions. The decision was based on two Phase 1 safety studies involving 116 patients, which confirmed that using three tubes did not increase the risk of side effects compared to the original single-tube regimen. This approval is expected to improve patient outcomes by providing a more comprehensive treatment option while maintaining the established safety and efficacy profile of Ameluz®.

Biofrontera FDA Events - Frequently Asked Questions

Has Biofrontera received FDA approval?

As of now, Biofrontera (BFRA) has not received any FDA approvals for its therapy in the last two years.

What drugs has Biofrontera submitted to the FDA?

In the past two years, Biofrontera (BFRA) has reported FDA regulatory activity for Ameluz.

What is the most recent FDA event for Biofrontera?

The most recent FDA-related event for Biofrontera occurred on August 25, 2025, involving Ameluz. The update was categorized as "evaluation," with the company reporting: "Biofrontera Inc. announced that the final patient in its Phase 2b clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris (AV) completed participation on August 22, 2025."

What conditions do Biofrontera's current drugs treat?

Currently, Biofrontera has one therapy (Ameluz) targeting the following condition: For treatment of actinic keratosis.