This section highlights FDA-related milestones and regulatory updates for drugs developed by Organon & Co. (OGN).
Over the past two years, Organon & Co. has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BILDYOS®, VTAMA, OG-6219, Perjeta, and HLX14. 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.
BILDYOS® FDA Regulatory Events
BILDYOS® is a drug developed by Organon & Co. for the following indication: for treatment of postmenopausal women with osteoporosis at high.
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:
- BILDYOS®
- Announced Date:
- September 2, 2025
- Indication:
- for treatment of postmenopausal women with osteoporosis at high
Announcement
Shanghai Henlius Biotech, Inc and Organon announced the US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA® (denosumab-nxxp) injection 120 mg/1.7 mL,biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.1,2
AI Summary
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VTAMA (tapinarof) cream FDA Regulatory Events
VTAMA (tapinarof) cream is a drug developed by Organon & Co. for the following indication: Plaque psoriasis.
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:
- VTAMA (tapinarof) cream
- Announced Date:
- July 7, 2025
- Indication:
- Plaque psoriasis
Announcement
Organon announced that VTAMA® (tapinarof) cream, 1%,was granted a strong recommendation by the American Academy of Dermatology (AAD) in their 2025 focused guideline update for the management of adults with moderate to severe atopic dermatitis (AD).
AI Summary
Organon announced that VTAMA® (tapinarof) cream, 1%, received a strong recommendation from the American Academy of Dermatology (AAD) in their 2025 focused guideline update for managing adults with moderate to severe atopic dermatitis (AD). The guideline highlights VTAMA cream as a highly effective, steroid-free option that is proven to be safe and tolerable. Clinical trials ADORING 1 and ADORING 2 played a key role in confirming its benefits, while long-term data from ADORING 3 also supported its positive safety profile. Unlike many treatments, VTAMA cream comes with no label warnings, contraindications, or restrictions on its use, making it a flexible daily treatment option.
This recommendation is particularly important for the 6.6 million US adults living with moderate to severe AD who need reliable treatment options. The strong endorsement by the AAD reinforces VTAMA cream’s potential to reshape the management of AD and offer lasting relief to patients.
Read Announcement- Drug:
- VTAMA (tapinarof) cream
- Announced Date:
- March 8, 2025
- Indication:
- Plaque psoriasis
Announcement
Organon announced results from an analysis of the Phase 3 ADORING 3 open-label, long-term extension study evaluating VTAMA® (tapinarof) cream, 1% once daily in adults and children 2 years of age and older with atopic dermatitis (AD), also known as eczema.
AI Summary
Organon recently shared positive results from the Phase 3 ADORING 3 study, which evaluated VTAMA® (tapinarof) cream, 1% used once daily in adults and children aged 2 years and older with atopic dermatitis (AD). The study showed that after patients achieved clear skin, they took an average break of about 80 days from using VTAMA cream. During this treatment-free period, most patients maintained a low level of disease activity, with 84% of them reaching a mild level of AD. Additionally, the mean weekly Peak Pruritus Numerical Rating Scale (PP-NRS) score, which measures itch severity, stayed low at 2.9, suggesting sustained relief from itch symptoms. These findings indicate that VTAMA cream may offer long-lasting benefits in managing AD, providing patients with extended periods of relief even after stopping treatment temporarily.
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OG-6219 FDA Regulatory Events
OG-6219 is a drug developed by Organon & Co. for the following indication: In Patients with Endometriosis-Related Pain.
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:
- OG-6219
- Announced Date:
- July 2, 2025
- Indication:
- In Patients with Endometriosis-Related Pain
Announcement
Organon announced that the Phase 2 ELENA proof-of-concept study evaluating the investigational candidate OG-6219 in endometriosis-related pain did not meet its primary efficacy endpoint.
AI Summary
Organon announced that its Phase 2 ELENA proof-of-concept study for OG-6219 did not meet its primary endpoint. The investigational drug, an oral HSD17B1 inhibitor acquired from Forendo Pharma in 2021, was tested to assess its ability to lessen moderate-to-severe endometriosis-related pelvic pain. In the randomized, double-blind study, pre-menopausal women with surgically confirmed endometriosis received one of three doses of OG-6219 or a placebo. The results showed that patients taking OG-6219 did not experience significant improvement in overall pelvic pain compared to those on placebo.
After reviewing the data, Organon has decided to discontinue the clinical development program for OG-6219. Despite this setback, the company remains committed to advancing treatments for women’s health and will continue to seek new solutions for conditions like endometriosis.
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Perjeta FDA Regulatory Events
Perjeta is a drug developed by Organon & Co. for the following indication: A neoadjuvant therapy in patients with HER2-positive, HR-negative early, or locally advanced breast cancer as part of a complete treatment regimen.
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:
- Perjeta
- Announced Date:
- September 30, 2024
- Indication:
- A neoadjuvant therapy in patients with HER2-positive, HR-negative early, or locally advanced breast cancer as part of a complete treatment regimen.
Announcement
Organon and Shanghai Henlius Biotech, Inc announced that the phase 3 comparative clinical trial for the investigational Perjeta® (pertuzumab) biosimilar HLX11 met the primary endpoint.
AI Summary
Organon and Shanghai Henlius Biotech, Inc. announced that their phase 3 clinical trial for the investigational biosimilar HLX11, a candidate for Perjeta® (pertuzumab), met its primary endpoint. The randomized, double-blind study compared HLX11 with the reference Perjeta® in patients diagnosed with HER2-positive, HR-negative early or locally advanced breast cancer. Patients in the trial received either HLX11 or Perjeta® along with trastuzumab and docetaxel every three weeks over four cycles. The primary endpoint was the total pathological complete response rate as determined by an independent review committee, and achieving this goal indicates that HLX11 shows comparable efficacy and safety to the established treatment.
This positive outcome supports further development of HLX11 as a potential alternative in breast cancer treatment and highlights the progressing role of biosimilars in oncology, offering promise for expanded treatment options in the future.
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HLX14 FDA Regulatory Events
HLX14 is a drug developed by Organon & Co. for the following indication: (denosumab) Biosimilar Candidate.
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:
- HLX14
- Announced Date:
- April 6, 2024
- Indication:
- (denosumab) Biosimilar Candidate
Announcement
Shanghai Henlius Biotech, Inc. (2696.HK) and Organon announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints.
AI Summary
Shanghai Henlius Biotech, Inc. (2696.HK) and Organon have announced that their phase 3 clinical trial for HLX14, a biosimilar to denosumab marketed as Prolia® and Xgeva®, met its primary endpoints. The randomized, double-blind, international study compared HLX14 with an EU-sourced reference denosumab in postmenopausal women with osteoporosis who are at high risk for fractures.
The trial focused on key measures such as changes in bone mineral density at the lumbar spine at 52 weeks and serum type I collagen C-telopeptide levels at 26 weeks. Achieving these primary endpoints marks an important milestone for HLX14, supporting its potential as a safe and effective biosimilar treatment. This success sets the stage for future development and commercialization under the exclusive agreement covering the U.S., European Union, and Canada.
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