Sumitomo Pharma America Holdings
Sumitomo Pharma America Holdings is the U.S. subsidiary of Sumitomo Pharma Co., Ltd., commercializing GEMTESA and ORGOVYX while developing PEGylated liposome and iPS cell-based therapies across oncology, urology, rare disease, and CNS.
- Company typePrivate
- Founded2009
- HeadquartersMarlborough, United States
- Headcount1,001–5,000
- GTM typeB2B
- OfferingHardware or Manufacturing
What Sumitomo Pharma America Holdings does
Sumitomo Pharma America Holdings is the U.S. operating subsidiary of Japanese pharmaceutical company Sumitomo Pharma Co., Ltd., headquartered in Marlborough, Massachusetts, and focused on oncology, women's health, urology, rare disease, CNS, and cell & gene therapies. The company markets two approved prescription drugs in the United States — GEMTESA (vibegron), a beta-3 adrenergic receptor agonist for overactive bladder, and ORGOVYX (relugolix), an oral GnRH receptor antagonist for advanced prostate cancer — generating revenue through traditional pharmaceutical distribution and field sales to U.S. healthcare providers and institutions.
The company's clinical pipeline rests on two proprietary technology platforms: PEGylated liposome drug delivery systems, exemplified by the investigational CHK1 inhibitor SMP-3124LP (currently in Phase 1 for heavily pretreated advanced solid tumors, reporting a 48.2% disease control rate at ASCO 2026), and iPS cell-derived regenerative cell therapy, exemplified by DSP-3077, a retinal sheet implant for retinitis pigmentosa that received FDA orphan drug designation in March 2026. Additional pipeline assets include the menin inhibitor enzomenib (relapsed/refractory AML) and nuvisertib (myelofibrosis), both with data presented at ASH 2025.
As a wholly-owned subsidiary of Sumitomo Pharma Co., Ltd., the company does not have independent public funding or shareholders; capital allocation, strategic direction, and global R&D prioritization flow from the Japanese parent. The U.S. entity operates with a focused 51–100 employee footprint concentrated on clinical development, regulatory affairs, and commercialization of its two marketed products, with growth oriented around pipeline progression, label expansion (e.g., GEMTESA in men 75+ with BPH, ORGOVYX in OPTYX), and entry into adjacent rare disease and regenerative medicine indications.
Sumitomo Pharma America Holdings firmographics
Firmographics- Name
- Sumitomo Pharma America Holdings
- Legal name
- Sumitomo Pharma America, Inc.
- Website
- https://us.sumitomo-pharma.com
- Company type
- Private
- Founded year
- 2009
- Operating status
- Operating
- Headcount range
- 1,001–5,000 employees
- Short description
- Sumitomo Pharma America Holdings is the U.S. subsidiary of Sumitomo Pharma Co., Ltd., commercializing GEMTESA and ORGOVYX while developing PEGylated liposome and iPS cell-based therapies across oncology, urology, rare disease, and CNS.
- Ownership category
- akta.pro rank
Sumitomo Pharma America Holdings industry classification
Industry- Product category
- Specialty Pharmaceuticals
- NAICS
- Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254)
- SIC
- Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Specialty Care Pharmaceuticals (HLAIAAAB)
- akta.pro secondary industries
- Nephrology & Urology Specialty Pharmaceuticals (HLAIACAH), Endocrinology & Reproductive Health Pharmaceuticals (incl. Women’s Health) (HLAIAAAJ)
Keywords
Where Sumitomo Pharma America Holdings is headquartered
LocationHeadquarters
- HQ city
- Marlborough
- HQ country
- United States
- HQ region
- North America
Markets served
Sumitomo Pharma America Holdings business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Marketing or Sales, Operations, Supply Chain
Distribution channels1 record
Marketing channels3 records
Sumitomo Pharma America Holdings product offering
Product offeringCore offering
Sumitomo Pharma America Holdings is a U.S. biopharmaceutical company that discovers, develops, and commercializes prescription drugs and investigational therapies across oncology, women's health, urology, rare disease, CNS, and cell & gene therapies. Its marketed products include GEMTESA (vibegron) for overactive bladder and ORGOVYX (relugolix) for advanced prostate cancer, supported by a clinical pipeline spanning liposomal cancer therapies, iPS cell-derived regenerative medicines, and menin inhibitors.
Product overview
Sumitomo Pharma America Holdings operates as a biopharmaceutical company with a portfolio of marketed prescription drugs and a diverse pipeline of investigational therapies. Marketed products include GEMTESA (vibegron) for overactive bladder and ORGOVYX (relugolix) for advanced prostate cancer. The clinical pipeline includes SMP-3124LP (PEGylated liposome CHK1 inhibitor for solid tumors), DSP-3077 (regenerative cell therapy for retinitis pigmentosa), enzomenib (for acute myeloid leukemia), and nuvisertib (for myelofibrosis). The company focuses on therapeutic areas including oncology, women's health, urology, rare disease, CNS, and cell & gene therapies.
Differentiator
Problem solved
Functional benefit
Products and services
- GEMTESA (vibegron)
Quantifiable outcome
- 48.2% disease control rate with five partial responses in Phase 1 trial of SMP-3124LP in heavily pretreated advanced solid tumors (61 patients enrolled)
- +1 more outcomes
Companies that use Sumitomo Pharma America Holdings
Customer profileSegments5 records
Ideal customer profiles1 record
Sumitomo Pharma America Holdings technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
Sumitomo Pharma America Holdings partnerships and signals
Strategic signalRecent moves5 records
Expansion highlights5 records
Sumitomo Pharma America Holdings competitors and assessment
Company assessmentEmerging players
- UroGen Pharma: Specialty urology-focused biopharmaceutical company working on uro-oncology and urologic conditions. Comparable as a smaller specialist addressing underserved urology patients, including elderly populations relevant to vibegron's positioning.
- Jazz Pharmaceuticals: Specialty biopharmaceutical company with oncology and CNS franchises, including myelofibrosis and AML adjacencies. Comparable mid-cap specialty pharma focused on differentiated therapies in defined patient populations.
Broad incumbents
- Pfizer: One of the largest global pharmaceutical companies with broad oncology, urology, and rare disease portfolios. Competes across multiple Sumitomo Pharma America therapeutic areas and serves as a benchmark for U.S. commercial scale.
- AbbVie: Large-cap biopharmaceutical incumbent with major oncology, urology, and neuroscience franchises. Competes broadly across Sumitomo Pharma America's therapeutic areas with deeper resources and established U.S. infrastructure.
- Bristol-Myers Squibb: Major oncology incumbent with a menin inhibitor (Revumenib) competing with enzomenib in AML, plus established hematology and solid tumor franchises. Direct competitor in leukemias and myeloproliferative neoplasms.
Direct peers
- Incyte Corporation: Specialty hematology/oncology company with the dominant myelofibrosis franchise (Jakafi/ruxolitinib) directly competing with nuvisertib. Also has menin inhibitor and AML programs overlapping enzomenib.
- Daiichi Sankyo: Japanese global pharmaceutical company with significant oncology pipeline (DXd ADC platform) and U.S. commercial operations. Comparable as another Japanese parent operating a U.S. specialty pharma subsidiary with innovative oncology assets.
- Kyowa Kirin: Japanese-headquartered specialty pharmaceutical company with U.S. operations focused on rare diseases, oncology, and cell therapy. Highly comparable business model as a Japanese parent with a U.S. specialty pharma subsidiary.
- Myovant Sciences: Originally developed relugolix (ORGOVYX) and is now part of Sumitomo Pharma — directly comparable for prostate cancer and women's health assets, and illustrates the value Sumitomo Pharma America captures in urology and reproductive health.
- Astellas Pharma: Japanese-headquartered global pharmaceutical company with significant urology and oncology franchises (Xtandi for prostate cancer, VESIcare for OAB). Directly comparable as a Japanese parent with a U.S. specialty pharma subsidiary operating in overlapping therapeutic areas.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
Sumitomo Pharma America Holdings social profiles
Digital presenceSumitomo Pharma America Holdings financial estimates
Financial estimateRevenue estimate
Valuation estimate
Sumitomo Pharma America Holdings leadership team
Management profileNumber of profiles
Profiles2 records
Sumitomo Pharma America Holdings funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Sumitomo Pharma America Holdings M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Sumitomo Pharma America Holdings
What does Sumitomo Pharma America Holdings do?
Sumitomo Pharma America Holdings is a U.S. biopharmaceutical company that discovers, develops, and commercializes prescription drugs and investigational therapies across oncology, women's health, urology, rare disease, CNS, and cell & gene therapies. Its marketed products include GEMTESA (vibegron) for overactive bladder and ORGOVYX (relugolix) for advanced prostate cancer, supported by a clinical pipeline spanning liposomal cancer therapies, iPS cell-derived regenerative medicines, and menin inhibitors.
Is Sumitomo Pharma America Holdings a public or private company?
Sumitomo Pharma America Holdings is a private company. It is classified as corporate owned and is currently operating.
When was Sumitomo Pharma America Holdings founded?
Sumitomo Pharma America Holdings was founded in 2009. It employs 1,001 to 5,000 people.
Where is Sumitomo Pharma America Holdings based?
Sumitomo Pharma America Holdings is headquartered in Marlborough, United States, in the North America region.
Who are Sumitomo Pharma America Holdings's main competitors?
Emerging players on record are UroGen Pharma and Jazz Pharmaceuticals. Broad incumbents are Pfizer, AbbVie and Bristol-Myers Squibb. Direct peers are Incyte Corporation, Daiichi Sankyo, Kyowa Kirin, Myovant Sciences and Astellas Pharma.
Does Sumitomo Pharma America Holdings have an API?
No public API is recorded for Sumitomo Pharma America Holdings.
What industry is Sumitomo Pharma America Holdings in?
Sumitomo Pharma America Holdings's product category is Specialty Pharmaceuticals. Its primary akta.pro industry code is HLAIAAAB, Specialty Care Pharmaceuticals, with a secondary code of HLAIACAH, Nephrology & Urology Specialty Pharmaceuticals. Its NAICS code is 325412 and its SIC code is 2834.