Cycle Pharmaceuticals
Cycle Pharmaceuticals is a UK-headquartered rare disease pharmaceutical company founded in 2012 that develops and commercializes 10 FDA-approved treatments across oncology, neurology, metabolics, and immunology, distributed via US specialty pharmacy networks and supported by the Cycle Vita patient hub.
- Company typePrivate
- Founded2012
- HeadquartersCambridge, United States
- Headcount101–250
- GTM typeB2B
- OfferingHardware or Manufacturing
What Cycle Pharmaceuticals does
Cycle Pharmaceuticals is a UK-headquartered, privately-held specialty pharmaceutical company founded in 2012 by James Harrison to develop and commercialize treatments for rare and ultra-rare diseases. The company operates from Cambridge, UK, with US offices in Detroit and Boston, and employs over 100 people across multiple nationalities. Cycle has assembled a portfolio of 10 FDA-approved products spanning oncology (PHYRAGO/dasatinib, CAVHANZA/nilotinib ODT), neurology (TASCENSO ODT/fingolimod, BAFIERTAM/monomethyl fumarate), metabolics (NITYR/nitisinone, HARLIKU/nitisinone, JAVYGTOR/sapropterin), immunology (SAJAZIR/icatibant), and urology/nephrology (VENXXIVA/tiopronin, ORMALVI/dichlorphenamide).
Cycle's core technical capability is drug reformulation — applying technologies including orally disintegrating tablet (ODT) formulations via Catalent's ZYDIS platform and Flex Pharma's ElectroNanoSpray (ENS) platform to improve form factor, swallowability, and co-medication compatibility (notably acid-reducing agent compatibility for TKIs). The company's commercial model relies on US specialty pharmacy distribution through exclusive partners (Onco360, LeMed, Anovo) and the three major US pharmaceutical distributors (McKesson, Cencora, Cardinal Health). Patient engagement is anchored by the Cycle Vita support hub providing financial, clinical, and adherence services, supplemented by the AI-enabled Cycle Vita PKU app. Internationally, Cycle operates a Free Goods Programme in 15 countries via partner Inceptua, embedding patient access in the company's constitutional documents. Recent M&A (Banner Life Sciences in January 2025, Applied Therapeutics in February 2026) has expanded the neurology and CNS rare metabolic disease franchises respectively.
Cycle Pharmaceuticals firmographics
Firmographics- Name
- Cycle Pharmaceuticals
- Legal name
- Cycle Pharmaceuticals Limited
- Website
- https://cyclepharma.com
- Company type
- Private
- Founded year
- 2012
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- Cycle Pharmaceuticals is a UK-headquartered rare disease pharmaceutical company founded in 2012 that develops and commercializes 10 FDA-approved treatments across oncology, neurology, metabolics, and immunology, distributed via US specialty pharmacy networks and supported by the Cycle Vita patient hub.
- Ownership category
- akta.pro rank
Cycle Pharmaceuticals industry classification
Industry- Product category
- Specialty Pharmaceuticals (Rare Disease)
- NAICS
- Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254)
- SIC
- Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Specialty Care Pharmaceuticals (HLAIAAAB)
- akta.pro secondary industries
- Small-Molecule Generics (Branded/Unbranded) (HLAIABAA), Generic ANDA/Regulatory Affairs & Submissions (HLAIABAJ)
Keywords
Where Cycle Pharmaceuticals is headquartered
LocationHeadquarters
- HQ city
- Cambridge
- HQ country
- United States
- HQ region
- North America
Offices4 records
Markets served
Cycle Pharmaceuticals business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Supply Chain, Technology or R&D, Personnel, Marketing or Sales, Operations
Revenue model
- Pharmaceutical Product Sales: Cycle Pharmaceuticals generates revenue through the sale of FDA-approved pharmaceutical products for rare diseases and oncology. The company commercializes branded drugs across multiple therapeutic areas (metabolic, immunological, neurological, oncology) through specialty pharmacy distribution networks in the US market, complemented by patient support programs.
- Free Goods Programme: Cycle operates a Free Goods Programme (Special Access Scheme/Compassionate Use Programme) providing nitisinone to patients with HT-1 and AKU in countries where they are unlikely to have means to pay, at no cost to patients. This is embedded in the company's constitutional documents and represents a non-revenue charitable program.
Go-to-market motion2 records
Distribution channels5 records
Marketing channels5 records
Cycle Pharmaceuticals product offering
Product offeringCore offering
Cycle Pharmaceuticals develops, reformulates, and commercializes FDA-approved pharmaceutical products for rare and ultra-rare diseases across oncology, neurology, metabolics, and immunology. The company distributes branded therapies (e.g., NITYR, HARLIKU, PHYRAGO, CAVHANZA, TASCENSO ODT, BAFIERTAM, SAJAZIR, JAVYGTOR, ORMALVI, VENXXIVA) through specialty pharmacy networks in the US and supplements its commercial offering with the Cycle Vita patient support programme and an international Free Goods Programme.
Product overview
Cycle Pharmaceuticals is a rare disease-focused pharmaceutical company offering a portfolio of treatments across oncology, neurology/metabolics, immunology, and urology. The company operates as a single-brand pharmaceutical manufacturer with patient support services. Core products include NITYR (nitisinone) for HT-1, SAJAZIR (icatibant) for HAE, JAVYGTOR (sapropterin) for PKU, TASCENSO ODT (fingolimod) for MS, BAFIERTAM (monomethyl fumarate) for MS, ORMALVI (dichlorphenamide) for periodic paralysis, VENXXIVA (tiopronin) for cystinuria, and HARLIKU (nitisinone) for AKU. In oncology, the portfolio includes PHYRAGO (dasatinib) for Ph+ leukemias and CAVHANZA (nilotinib) for Ph+ CML. The company also provides the Cycle Vita™ patient support platform including a PKU management app. Following the 2026 acquisition of Applied Therapeutics, the pipeline expanded to include govorestat for CNS rare metabolic diseases.
Differentiator
Problem solved
Functional benefit
Brands
- Cycle Vita: Patient support programme for patients in the US providing individualized emotional, financial, and product support.
- Cycle Vita PKU
Products and services
- PHYRAGO (dasatinib) Tablets Tyrosine kinase inhibitor tablet for adults and pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and acute lymphoblastic leukemia (Ph+ ALL). Bioequivalent to Sprycel with the unique clinical benefit of allowing co-administration with proton pump inhibitors and H2 receptor antagonists.
- CAVHANZA (nilotinib) Orally Disintegrating Tablets Orally disintegrating kinase inhibitor tablet for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in newly diagnosed adults in chronic phase and adults with chronic and accelerated phase Ph+ CML resistant or intolerant to prior therapy including imatinib. First nilotinib formulation allowing co-administration with acid-reducing agents without timing restrictions, using Flex Pharma's ElectroNanoSpray technology for improved solubility and dissolution.
- HARLIKU (nitisinone) Tablets First and only FDA-approved treatment for reducing urinary homogentisic acid (HGA) in adult patients with alkaptonuria (AKU/Black Bone Disease). Reduces urinary HGA production by up to 97% through enzyme inhibition.
- BAFIERTAM (monomethyl fumarate) Delayed-Release Capsules Disease-modifying therapy for relapsing forms of multiple sclerosis. A unique fumarate agent requiring no dietary restrictions and no metabolic conversion, acquired from Banner Life Sciences.
- TASCENSO ODT (fingolimod) Sphingosine 1-phosphate receptor modulator for relapsing forms of MS including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. First orally disintegrating tablet for MS patients, using Catalent ZYDIS technology.
- VENXXIVA (tiopronin) Delayed-Release Tablets Reducing and complexing thiol for prevention of cystine stone formation in patients with severe homozygous cystinuria. Available in 100mg and 300mg doses, to be taken without food.
- ORMALVI (dichlorphenamide) Tablets Oral carbonic anhydrase inhibitor for treatment of primary hyperkalemic periodic paralysis (HyperPP), hypokalemic periodic paralysis (HypoPP), and related variants.
- SAJAZIR (icatibant) Injection Bradykinin B2 receptor antagonist for treatment of acute attacks of hereditary angioedema (HAE) in adults 18+. Self-administered subcutaneous injection delivering 30mg icatibant.
- JAVYGTOR (sapropterin dihydrochloride) Treatment to reduce blood phenylalanine levels in patients with tetrahydrobiopterin-responsive Phenylketonuria (PKU). Available as 100mg tablets and 100mg/500mg powder for oral solution, used in conjunction with a Phe-restricted diet.
- NITYR (nitisinone) Tablets Treatment for Hereditary Tyrosinemia Type 1 (HT-1), Cycle's original commercial product launched in 2017 and updated in 2018 for infant administration dosing.
- Cycle Vita Patient Support Program Comprehensive patient support hub providing individualized emotional, financial, and product support for patients on Cycle medications, including co-pay assistance, bridge programs, registered dietitian nutrition support, and the Cycle Vita PKU mobile app.
- Cycle Vita PKU Mobile App Smartphone application for PKU management featuring medication and lab result tracking, diet management tools, and an AI-powered meal scanner for food identification and nutritional analysis. Available on iOS App Store and Google Play.
Quantifiable outcome
- HARLIKU (nitisinone) reduces urinary homogentisic acid (HGA) production by up to 97% in AKU patients
- +3 more outcomes
Companies that use Cycle Pharmaceuticals
Customer profileNamed customers6 records
Segments5 records
Ideal customer profiles3 records
Cycle Pharmaceuticals technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability2 records
Feature4 records
Cycle Pharmaceuticals partnerships and signals
Strategic signalPartnerships
Twelve partnerships are on record, tiered core.
- Flex PharmacoreCycle partnered with Flex Pharma for CAVHANZA (nilotinib) ODT formulation. Flex contributed its proprietary ElectroNanoSpray (ENS) platform technology to develop an improved nilotinib formulation with maintained bioavailability when taken with acid-reducing agents, addressing a significant unmet need in CML treatment.
- Applied Therapeutics, Inc.coreCycle completed the acquisition of Applied Therapeutics, a NASDAQ-listed clinical-stage biopharma focused on rare metabolic diseases. Applied's lead drug candidate govorestat (CNS-penetrant Aldose Reductase Inhibitor) targets Classic Galactosemia, CMT-SORD, and PMM2-CDG. The all-cash transaction was funded from Cycle's existing cash reserves.
- Handa Therapeutics, LLCcoreCycle launched PHYRAGO (dasatinib) tablets in partnership with Handa Therapeutics, LLC. Handa developed the product and granted Cycle an exclusive U.S. sales license. PHYRAGO is a tyrosine kinase inhibitor for Ph+ CML and Ph+ ALL, bioequivalent to Sprycel with improved PPI/H2RA compatibility.
- Onco360coreOnco360 selected as the exclusive specialty pharmacy partner for PHYRAGO (dasatinib). Onco360 is the nation's largest independent Oncology Pharmacy and dispenses nationally through its URAC- and ACHC-accredited network.
- McKesson, Cencora, Cardinal HealthcoreCycle established a specialty distribution network from McKesson, Cencora, and Cardinal Health for PHYRAGO, ensuring broad access through major pharmaceutical distributors.
- LeMed Specialty PharmacycoreCycle awarded LeMed Specialty Pharmacy an exclusive contract for distributing HARLIKU (nitisinone) Tablets in the US, the first FDA-approved treatment for AKU. LeMed manages commercial and non-commercial dispensing.
- Banner Life Sciences, LLCcoreCycle acquired Banner Life Sciences, a U.S. company offering BAFIERTAM (monomethyl fumarate) for relapsing forms of multiple sclerosis, strengthening Cycle's neurological disorder portfolio in the U.S. market. BAFIERTAM became part of Cycle's product portfolio.
- Torrent Pharma Inc.corePartnership between Cycle and Torrent Pharma for tiopronin delayed-release tablets (VENXXIVA) and ORMALVI (dichlorphenamide). Torrent supplies the products while Cycle handles US commercialization and patient support via Cycle Vita.
- Anovo Specialty PharmacycoreAnovo serves as the exclusive specialty pharmacy for tiopronin delayed-release tablets, providing end-to-end services including specialty wholesale/distribution, specialty pharmacy services, and patient support hub programs.
- Inceptua GroupcoreCycle partnered with Inceptua to provide its Free Goods Programme for patients with HT-1 and AKU in 15 countries where rare disease medication is unaffordable. Inceptua handles the logistics and compliance of making nitisinone available under the Special Access Scheme.
- Dr Reddy's Laboratories LtdcoreEstablished partnership between Cycle and Dr Reddy's for JAVYGTOR (sapropterin dihydrochloride) for PKU treatment. Cycle commercializes the product in the US while Dr Reddy's manufactures and supplies. Both companies are committed to providing affordable medicines to rare disease patients.
- AKU SocietycoreCycle works collaboratively with the AKU Society, a global patient advocacy group supporting patients and families with Alkaptonuria, funding research, and helping patients access HARLIKU treatment.
Scale indicators6 records
Recent moves8 records
Expansion highlights6 records
Cycle Pharmaceuticals competitors and assessment
Company assessmentBroad incumbents
- BioMarin Pharmaceutical: Established rare disease biopharma with a broader portfolio of branded therapeutics for rare conditions. Comparable as a larger incumbent in the rare disease space with similar commercial and patient support infrastructure.
- Alexion (AstraZeneca Rare Disease): Larger rare disease franchise within AstraZeneca focused on rare neurological, metabolic, and immunological conditions. Comparable as a broad incumbent operating in overlapping rare disease therapeutic areas with Cycle's immunology and metabolic portfolio.
- Swedish Orphan Biovitrum (Sobi): Specialty biopharma with significant focus on rare diseases across immunology, hematology, and metabolic indications. Comparable to Cycle's strategy of addressing rare disease patient communities through specialized products and support services.
- Jazz Pharmaceuticals: Specialty pharmaceutical company with franchises in neurology and oncology rare diseases. Comparable to Cycle's specialty pharmacy distribution model and focus on conditions with limited treatment options.
- Horizon Therapeutics (Amgen): Rare disease specialty pharma (now part of Amgen) with focus on rare inflammatory, autoimmune, and metabolic diseases. Comparable to Cycle's specialty distribution model and therapeutic diversity across rare conditions.
Direct peers
- Recordati Rare Diseases: Specialty pharmaceutical company focused on rare diseases across metabolic, endocrine, and oncology indications. Directly comparable to Cycle in its strategy of acquiring, reformulating, and commercializing treatments for rare disease patients through specialty channels.
- Ultragenyx Pharmaceutical: Rare disease biopharma developing and commercializing therapies for rare and ultra-rare genetic diseases. Directly comparable to Cycle's rare metabolic and neurological disease focus areas and orphan drug commercialization approach.
- Amryt Pharma (acquired by Chiesi): Rare disease specialty pharma that developed and commercialized treatments for rare and ultra-rare conditions, including metabolic diseases. Comparable to Cycle's rare metabolic disease focus and reformulation approach before its acquisition.
Others
- Dr Reddy's Laboratories: Major generics manufacturer and Cycle's manufacturing partner for JAVYGTOR. Comparable to Cycle as a partnership counterparty in the rare disease generic/specialty space and as a relevant scale reference for global pharmaceutical supply.
Emerging players
- Eton Pharmaceuticals: Emerging specialty pharma focused on rare disease product development and commercialization. Comparable to Cycle as a smaller, growth-oriented rare disease player pursuing commercial launches in underserved indications.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key risks5 records
Key highlights7 records
Customer concentration
Cycle Pharmaceuticals social profiles
Digital presenceCycle Pharmaceuticals financial estimates
Financial estimateRevenue estimate
Valuation estimate
Cycle Pharmaceuticals leadership team
Management profileNumber of profiles
Profiles9 records
Cycle Pharmaceuticals subsidiaries and ownership
Company hierarchySubsidiaries3 records
Cycle Pharmaceuticals funding detail
Funding detailFunding overview
Funding rounds1 record
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Cycle Pharmaceuticals M&A and investment
M&A and investmentM&A2 records
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Cycle Pharmaceuticals
What does Cycle Pharmaceuticals do?
Cycle Pharmaceuticals develops, reformulates, and commercializes FDA-approved pharmaceutical products for rare and ultra-rare diseases across oncology, neurology, metabolics, and immunology. The company distributes branded therapies (e.g., NITYR, HARLIKU, PHYRAGO, CAVHANZA, TASCENSO ODT, BAFIERTAM, SAJAZIR, JAVYGTOR, ORMALVI, VENXXIVA) through specialty pharmacy networks in the US and supplements its commercial offering with the Cycle Vita patient support programme and an international Free Goods Programme.
Is Cycle Pharmaceuticals a public or private company?
Cycle Pharmaceuticals is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Cycle Pharmaceuticals founded?
Cycle Pharmaceuticals was founded in 2012. It employs 101 to 250 people.
Where is Cycle Pharmaceuticals based?
Cycle Pharmaceuticals is headquartered in Cambridge, United States, in the North America region.
How does Cycle Pharmaceuticals make money?
Two revenue lines are on record. Pharmaceutical Product Sales are the primary driver. The others are free Goods Programme.
Who are Cycle Pharmaceuticals's main competitors?
Broad incumbents on record are BioMarin Pharmaceutical, Alexion (AstraZeneca Rare Disease), Swedish Orphan Biovitrum (Sobi), Jazz Pharmaceuticals and Horizon Therapeutics (Amgen). Direct peers are Recordati Rare Diseases, Ultragenyx Pharmaceutical and Amryt Pharma (acquired by Chiesi). Dr Reddy's Laboratories is listed as an others. Eton Pharmaceuticals is listed as an emerging player.
Does Cycle Pharmaceuticals have an API?
No public API is recorded for Cycle Pharmaceuticals.
What industry is Cycle Pharmaceuticals in?
Cycle Pharmaceuticals's product category is Specialty Pharmaceuticals (Rare Disease). Its primary akta.pro industry code is HLAIAAAB, Specialty Care Pharmaceuticals, with a secondary code of HLAIABAA, Small-Molecule Generics (Branded/Unbranded). Its NAICS code is 325412 and its SIC code is 2834.