This section highlights FDA-related milestones and regulatory updates for drugs developed by Ligand Pharmaceuticals (LGND).
Over the past two years, Ligand Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Lasix®, ZELSUVMI, QTORIN, and FCX-007. 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.
Lasix® ONYU FDA Regulatory Events
Lasix® ONYU is a drug developed by Ligand Pharmaceuticals for the following indication: Home Treatment for Edema in Heart Failure Patients.
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:
- Lasix® ONYU
- Announced Date:
- October 9, 2025
- Indication:
- Home Treatment for Edema in Heart Failure Patients
Announcement
Ligand Pharmaceuticals nnounced that its partner SQ Innovation Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Lasix® ONYU (furosemide injection), a novel drug-device combination for the treatment of edema (due to fluid overload) in adult patients with chronic heart failure.
AI Summary
Ligand Pharmaceuticals’ partner SQ Innovation Inc. has won FDA approval for Lasix® ONYU, a new drug-device combo to treat edema from fluid overload in adults with chronic heart failure. Lasix ONYU delivers a high-concentration furosemide injection (80 mg/2.67 mL) under the skin, so selected patients can receive treatment at home without a nurse or doctor present. The system uses a small, reusable Infusor unit good for 48 doses and a single-use sterile cartridge.
This product is the 17th to use Ligand’s Captisol® technology, which improves drug solubility, stability, and bioavailability. Lasix ONYU aims to match hospital IV diuresis while lowering costs and reducing the need for hospital stays. SQ Innovation expects to launch Lasix ONYU in the fourth quarter of 2025, offering a more convenient, cost-effective option for heart failure patients, healthcare providers, and payors.
Read Announcement
ZELSUVMI FDA Regulatory Events
ZELSUVMI is a drug developed by Ligand Pharmaceuticals for the following indication: For the Treatment of Molluscum Contagiosum.
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:
- ZELSUVMI
- Announced Date:
- July 10, 2025
- Indication:
- For the Treatment of Molluscum Contagiosum
Announcement
Pelthos Therapeutics Inc. announced the launch of ZELSUVMI™ (berdazimer) topical gel, 10.3%, for the treatment of molluscum contagiosum (molluscum) in adults and pediatric patients one year of age and older.i,ii
AI Summary
Pelthos Therapeutics Inc. has launched ZELSUVMI™ (berdazimer) topical gel, 10.3% for treating molluscum contagiosum in adults and pediatric patients aged one year and older. This prescription medication offers a once-daily, at-home option that allows patients, parents, and caregivers to manage the condition without frequent office visits. Molluscum contagiosum is a highly contagious viral skin infection that affects millions each year, making this new treatment a welcome option for many.
In clinical trials, ZELSUVMI showed effective results, with nearly one-third of patients achieving complete clearance of lesions. The product is now available at retail pharmacies, ASPN pharmacy services, and through mail-order pharmacies, aiming to ease the burden of this common pediatric and adult skin condition and provide a convenient treatment option outside of traditional clinical settings.
Read Announcement
QTORIN FDA Regulatory Events
QTORIN is a drug developed by Ligand Pharmaceuticals for the following indication: For the treatment of Microcystic Lymphatic Malformations (Microcystic LMs).
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:
- QTORIN
- Announced Date:
- April 2, 2025
- Indication:
- For the treatment of Microcystic Lymphatic Malformations (Microcystic LMs).
Announcement
Palvella Therapeutics, Inc announced a late-breaking oral presentation at the upcoming 15th World Congress of Pediatric Dermatology, taking place April 8-11, 2025, in Buenos Aires, Argentina..
AI Summary
Palvella Therapeutics, Inc. announced a late-breaking oral presentation at the upcoming 15th World Congress of Pediatric Dermatology in Buenos Aires, Argentina, from April 8-11, 2025. The company will share findings from the SELVA Phase 3 clinical trial, which evaluates QTORIN™ rapamycin 3.9% anhydrous gel for the treatment of microcystic lymphatic malformations in patients aged 3 years and older. The study, being presented by Dr. Amy Paller, focuses on a fit-for-purpose primary endpoint that measures the gel’s effectiveness against this rare condition, characterized by malformed lymphatic vessels that cause persistent leakage, bleeding, and related complications. This innovative approach is particularly important because there are currently no approved treatments for this lifelong, debilitating genetic disease. The presentation is expected to provide crucial insights into a potential new therapeutic option for affected patients.
Read Announcement- Drug:
- QTORIN
- Announced Date:
- October 3, 2024
- Indication:
- For the treatment of Microcystic Lymphatic Malformations (Microcystic LMs).
Announcement
Palvella Therapeutics, Inc announced the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has awarded the company a grant of up to $2.6 million to support the ongoing Phase 3 SELVA trial of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs).
Read Announcement
FCX-007 FDA Regulatory Events
FCX-007 is a drug developed by Ligand Pharmaceuticals for the following indication: In patients with dystrophic epidermolysis bullosa (DEB).
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:
- FCX-007
- Announced Date:
- February 25, 2025
- Indication:
- In patients with dystrophic epidermolysis bullosa (DEB).
Announcement
Ligand Pharmaceuticals announced it has closed a royalty financing agreement with Castle Creek Biosciences, Inc. to support the Phase 3 clinical study of D-Fi (FCX-007), Castle Creek's lead candidate, in patients with dystrophic epidermolysis bullosa (DEB).
AI Summary
Ligand Pharmaceuticals recently closed a royalty financing agreement with Castle Creek Biosciences to support the Phase 3 clinical trial of D-Fi (FCX-007), the company’s leading candidate for treating dystrophic epidermolysis bullosa (DEB). Under this agreement, Ligand invested $50 million and led a syndicate of co-investors who contributed an additional $25 million. In return, they will receive a high-single-digit royalty on the worldwide sales of D-Fi.
Dystrophic epidermolysis bullosa is a severe, rare genetic skin disorder, and D-Fi is an innovative gene therapy that uses a patient’s own modified cells. Both companies expressed confidence that this funding will drive the trial’s progress and help bring a much-needed treatment closer to patients. This strategic collaboration underlines Ligand’s commitment to backing promising therapies while expanding its portfolio of revenue-generating assets.
Read Announcement
Free LGND Stock Alerts