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
TOFIDENCE, VTAMA, NEXPLANON, BILDYOS®, OG-6219, and Perjeta. 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.
TOFIDENCE FDA Regulatory Events
TOFIDENCE is a drug developed by Organon & Co. for the following indication: in Cytokine Release Syndrome (CRS) and Pediatric COVID-19.
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:
- TOFIDENCE
- Announced Date:
- June 10, 2026
- Indication:
- in Cytokine Release Syndrome (CRS) and Pediatric COVID-19
Announcement
Organon announced the US Food and Drug Administration (FDA) approval of the supplemental Biologics License Application (sBLA) for TOFIDENCE® (tocilizumab-bavi) injection, for intravenous use, a biosimilar to ACTEMRA (tocilizumab).
AI Summary
Organon announced that the U.S. Food and Drug Administration approved its supplemental Biologics License Application for TOFIDENCE® (tocilizumab-bavi) injection, an intravenous biosimilar to ACTEMRA® (tocilizumab). TOFIDENCE is an interleukin-6 receptor blocker used to treat several inflammatory conditions. The company said the approval supports wider use of the medicine in the U.S. market, where Organon holds the regulatory and commercial rights. Bio-Thera Solutions, the product developer, will keep manufacturing rights for the U.S.
As with other tocilizumab products, TOFIDENCE can cause serious side effects, including severe infections, liver problems, low blood cell counts, and rare allergic reactions. Patients need close medical monitoring during treatment, and doctors should check for infection risk, liver tests, and other lab changes. Live vaccines should be avoided while taking TOFIDENCE.
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VTAMA (tapinarof) cream FDA Regulatory Timeline and 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:
- March 27, 2026
- Indication:
- Plaque psoriasis
Announcement
Organon will present results from a post-hoc sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials evaluating the efficacy and safety of VTAMA cream versus vehicle in an oral session at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, Colorado, on Saturday, March 28, 2026.
AI Summary
Organon will present a post-hoc sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials evaluating the efficacy and safety of VTAMA cream versus vehicle in an oral session at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, Colorado, on Saturday, March 28, 2026.
The pooled analysis included 813 adults and children aged 2 years and older who were randomized to VTAMA cream or vehicle once daily for 8 weeks. Results showed early and consistent improvement in disease severity (vIGA-AD and EASI) and in itch (PP-NRS) for patients with moderate to severe atopic dermatitis down to age 2. VTAMA was generally well tolerated; the most common treatment-emergent adverse events reported in ≥3% of patients were folliculitis, headache, upper respiratory tract infection, and nasopharyngitis.
Read Announcement- Drug:
- VTAMA (tapinarof) cream
- Announced Date:
- February 27, 2026
- Indication:
- Plaque psoriasis
Announcement
Organon will present results from a sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials evaluating VTAMA cream versus vehicle at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia, Pennsylvania, on February 27, 2026.
AI Summary
Organon will present results from a sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials evaluating VTAMA cream versus vehicle at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia on February 27, 2026. The analysis combines data from the two 8‑week trials to better assess effects across participants.
The pooled sub-analysis showed clinically meaningful improvements in sleep scores based on Patient‑Oriented Eczema Measure (POEM) subdomains and Dermatitis Family Impact (DFI) assessments as early as week 1, with benefits continuing through week 8. The most frequently reported treatment‑emergent adverse events (≥5% in any group) were folliculitis, headache, and nasopharyngitis.
The ADORING program also includes ADORING 3, a 48‑week open‑label extension. Organon’s presentation aims to give clinicians more detailed safety and symptom‑improvement data from the pooled trials.
Read Announcement- Drug:
- VTAMA (tapinarof) cream
- Announced Date:
- November 8, 2025
- Indication:
- Plaque psoriasis
Announcement
Organon will present results from a sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials evaluating VTAMA cream versus vehicle at the 2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Orlando, Florida, on November 8, 2025.
AI Summary
Organon will present a sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 trials evaluating VTAMA (tapinarof) cream versus vehicle at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting in Orlando on November 8, 2025. The analysis focused on 654 children aged 2–17 and examined outcomes through 8 weeks, comparing results for those with and without common atopic comorbidities like asthma, allergic rhinitis and food allergy.
Results showed early, clinically meaningful improvements across measures. vIGA-AD response rates were higher with VTAMA by week 1 (with comorbidities: 42.3% vs 11.8%; without: 49.5% vs 14.8%). EASI improvements appeared by week 2 and continued to week 8 (with: 54.5% vs 21.8%; without: 63.1% vs 20.4%). Patient-reported POEM scores and sleep improved by week 1, and itch (≥4‑point PP‑NRS) improved by week 2. Common adverse events included folliculitis (7.8%), upper respiratory infection (4.6%) and headache (3.7%).
Read Announcement- 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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NEXPLANON FDA Regulatory Events
NEXPLANON is a drug developed by Organon & Co. for the following indication: for use by women of reproductive potential to prevent pregnancy.
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:
- NEXPLANON
- Announced Date:
- January 16, 2026
- Indication:
- for use by women of reproductive potential to prevent pregnancy.
Announcement
Organon announced today that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for NEXPLANON® (etonogestrel implant), which is indicated for use by women of reproductive potential to prevent pregnancy.
AI Summary
Organon announced that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for NEXPLANON® (etonogestrel implant). The approval extends the implant’s indicated duration from three to five years for preventing pregnancy in women of reproductive potential.
In a U.S. clinical study of extended use during years 4 and 5, no pregnancies were reported and there were no new safety findings. The trial included 399 women with a wide range of body mass index (BMI) values; 38.1% had a BMI ≥30 kg/m2, supporting effectiveness across varied body sizes.
The approval requires a Risk Evaluation and Mitigation Strategy (REMS) to reduce complications from improper insertion and removal. NEXPLANON will be distributed only through the NEXPLANON REMS program, which strengthens provider training and certification. The REMS is planned to be available starting February 23, 2026, and providers will have six months to enroll to maintain access for insertions.
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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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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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