Organon & Co. is a science based global pharmaceutical company, which develops and delivers innovative health solutions through a portfolio of prescription therapies within women’s health, biosimilars and established brands. The company was founded on March 11, 2020, and is headquartered in Jersey City, NJ.
Clinical Trials
505
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2020
Active, not recruiting
2
0.4%
Completed
473
93.7%
Terminated
21
4.2%
Withdrawn
9
1.8%
No approval data available
- Shionogi and Torii Pharmaceutical obtained Japanese manufacturing and marketing approval for VTAMA Cream 0.5% (tapinarof) in atopic dermatitis patients under 12 years of age. - The approval rests on a domestic Phase 3 trial in children aged 2 to under 12 in which once-daily tapinarof for 8 weeks beat vehicle cream on the primary endpoint. - Long-term safety was assessed for up to 60 weeks of treatment, with the companies reporting favorable tolerability in the pediatric population. - Shionogi said the financial impact on consolidated results for the fiscal year ending March 2027 is expected to be minimal.
- Health Canada authorized Imuldosa (ustekinumab) on 21 January 2026 as a Stelara biosimilar for Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. - Henlius and Organon received Canadian approval on 24 March 2026 for Bildyos and Tuzemty, denosumab biosimilars referencing Prolia and Xgeva respectively. - Apotex's Denoza and Biocon's Bosaya and Vevzuo added further Canadian denosumab approvals in early April 2026, deepening the competitive field. - As of September 2026, Europe had approved 14 ustekinumab and 15 denosumab biosimilars, while the US had approved 8 and 19 respectively.
- The FDA has accepted for review a supplemental New Drug Application seeking to extend MIUDELLA's approved contraceptive duration from three to six years. - A PDUFA action date is expected in the second quarter of 2027, with MIUDELLA anticipated to become commercially available in late 2026. - The hormone-free copper intrauterine device showed a first-year Pearl Index of 0.94 and a cumulative three-year Pearl Index of 1.05 in Phase 3. - Organon licensed global rights to MIUDELLA from Sebela Women's Health in June 2026, and the device remains subject to a REMS insertion-training program.
- The US Court of Appeals for the Third Circuit affirmed summary judgment in favor of Sun Pharma and its subsidiaries, substantially closing the decade-old Lipitor antitrust litigation. - The appellate court upheld the denial of class certification to plaintiffs, significantly limiting their future legal recourse and reducing financial risks. - The litigation centered on a 2008 patent settlement with Pfizer that plaintiffs alleged unlawfully delayed generic competition for Lipitor (atorvastatin). - The resolution removes a major legal overhang, allowing Sun Pharma to focus on its core business, including its US$11.75 billion acquisition of Organon.
- Shionogi and Torii Pharmaceutical obtained Japanese manufacturing and marketing approval for VTAMA Cream 0.5% (tapinarof) for atopic dermatitis in pediatric patients under 12 years of age. - The approval was based on a domestic Phase 3 trial in children aged 2 to under 12 in which the drug met its primary efficacy endpoint versus vehicle cream. - Pooled Phase 3 ADORING data showed consistent vIGA-AD and EASI75 improvements across pediatric age groups, with responses observed as early as week 2. - Tapinarof is a first-in-class nonsteroidal topical aryl hydrocarbon receptor agonist, offering a steroid-free option for a disease that frequently develops in childhood.
- Samsung Bioepis and Organon announced expansion of their commercialization agreement to bring a fourth biosimilar product to Australia via Organon ANZ, deepening a partnership now in its thirteenth year. - Australia's biosimilar market reached approximately USD $906 million in 2025 and is forecast to reach USD $6.7 billion by 2034, yet anti-TNF biosimilar uptake in retail pharmacy sits at just 36 percent, well below the OECD average of 67 percent. - The 2026–27 Federal Budget included a commitment to reviewing whether biosimilars should become the default for new prescriptions, a reform the GBMA estimates could free up to $1.5 billion in PBS headroom over five years. - Sun Pharma's pending $11.75 billion acquisition of Organon, expected to close in early 2027, would make the combined entity the seventh-largest seller of biosimilars globally.
- Organon received FDA approval for a supplemental Biologics License Application expanding TOFIDENCE (tocilizumab-bavi) indications to include CAR T-cell-induced CRS and COVID-19 in hospitalized patients aged 2 and older. - TOFIDENCE, the first tocilizumab biosimilar entrant in the US market, was originally launched in May 2024 for rheumatoid arthritis, giant cell arteritis, and juvenile idiopathic arthritis. - The expanded approval addresses critical unmet needs, including CRS, a serious side effect of CAR-T therapies, and may help reduce the affordability burden of high-cost brand biologics on the healthcare system. - TOFIDENCE carries a Boxed Warning for serious infections, and patients must be closely monitored for signs of infection, hepatotoxicity, neutropenia, and other laboratory abnormalities during treatment.
- The SPDR S&P Pharmaceuticals ETF (XPH) delivered a 38.00% one-year total return as of June 3, 2026, outperforming the First Trust NYSE Arca Biotech ETF (FBT) at 35.90%. - XPH carries a lower expense ratio of 0.35% compared to FBT's 0.55%, offering a cost advantage for long-term investors in the pharmaceutical space. - Both ETFs concentrate 42% of assets in their top 10 holdings, with Corcept Therapeutics appearing as a top-10 position in each fund. - The SPDR Biotech ETF (XBI) posted a 58.30% one-year return but experienced a 54.70% maximum drawdown over five years, highlighting the higher volatility of the biotech sub-sector.
- Sun Pharmaceutical Industries Limited announced a definitive agreement to acquire Organon & Co. for $14.00 per share in an all-cash transaction valued at $11.75 billion. - The acquisition will position Sun Pharma among the top 25 global pharmaceutical companies with combined revenues of $12.4 billion and establish it as the 7th largest global biosimilar player. - The deal creates a top 3 global women's health company and enables Sun Pharma's entry into biosimilars while expanding its presence to 150 countries across 18 major markets. - The transaction is expected to close in early 2027, subject to regulatory approvals and Organon stockholder approval, with financing through cash resources and committed bank funding.
- The FDA has approved Bayer's Lynkuet, a nonhormonal treatment for menopausal vasomotor symptoms including hot flashes and night sweats, marking the company's entry into women's health therapeutics. - Lynkuet offers an alternative for patients who cannot or prefer not to undergo classical hormone therapy, addressing an identified unmet medical need in menopause care. - Bayer has launched the product in the US market with a major direct-to-consumer marketing campaign aimed at capturing early market share in this expanding therapeutic segment. - The approval comes as Bayer faces patent pressures on older blockbuster drugs and maintains its 2026 revenue forecast of 45-47 billion euros despite ongoing legal settlements.
