Achieve Life Science
Achieve Life Sciences is a late-stage specialty pharmaceutical company developing cytisinicline, a plant-based alkaloid partial agonist at nicotinic receptors, for adult smoking and vaping cessation in the United States.
- Company typePublic
- Founded1991
- HeadquartersMill Valley, United States
- Headcount11–50
- GTM typeB2C
- OfferingHardware or Manufacturing
What Achieve Life Science does
Achieve Life Sciences (NASDAQ: ACHV) is a late-stage specialty pharmaceutical company developing cytisinicline, a plant-derived alkaloid that acts as a partial agonist at α4β2 nicotinic acetylcholine receptors, for the treatment of nicotine dependence. The drug candidate reduces both the withdrawal symptoms and the reward/satisfaction associated with smoking and vaping by binding to the same receptors targeted by nicotine. The clinical development program spans five trials with 1,500+ exposed participants, including the positive Phase 3 ORCA-2 (810 subjects) and ORCA-3 (792 subjects) trials in adult smokers, where 12-week cytisinicline treatment demonstrated 30.3% continuous abstinence versus 9.4% on placebo (4.4x higher odds, p<0.0001) and a favorable tolerability profile with only 2.5% nausea over 52 weeks of continuous exposure. The Phase 2 ORCA-V1 trial in 160 adult e-cigarette users showed 2.6x higher odds of quitting vaping versus placebo (31.8% vs 15.1%, p=0.035), supporting a vaping cessation indication that has received FDA Breakthrough Therapy Designation and a Commissioner's National Priority Voucher.
The company submitted its cytisinicline NDA for smoking cessation in June 2025, which the FDA accepted in September 2025 with a PDUFA date of June 20, 2026. In June 2026, the FDA issued a Complete Response Letter citing third-party manufacturing facility deficiencies (no clinical efficacy or safety deficiencies identified); Achieve plans to resubmit in Q4 2026 using Adare Pharma Solutions as its new U.S. commercial manufacturer, with potential approval targeted for H1 2027. The company is pre-revenue, with FY2025 net loss of $54.6M and Q1 2026 net loss of $10.2M against $29.3M cash, and is funded to commercial launch primarily through an April 2026 private placement of up to $354M ($180M upfront) led by Frazier Life Sciences, TPG Life Sciences Innovations, venBio Partners, Paradigm BioCapital, and Marshall Wace.
Achieve Life Science firmographics
Firmographics- Name
- Achieve Life Science
- Legal name
- Achieve Life Sciences, Inc.
- Website
- https://achievelifesciences.com
- Company type
- Public
- Founded year
- 1991
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Achieve Life Sciences is a late-stage specialty pharmaceutical company developing cytisinicline, a plant-based alkaloid partial agonist at nicotinic receptors, for adult smoking and vaping cessation in the United States.
- Ownership category
- akta.pro rank
Achieve Life Science industry classification
Industry- Product category
- Smoking Cessation Pharmaceuticals
- NAICS
- Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)
- akta.pro secondary industries
- Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH), Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE)
Keywords
Where Achieve Life Science is headquartered
LocationHeadquarters
- HQ city
- Mill Valley
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Achieve Life Science business model
Business model- GTM type
- B2C
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Others
Revenue model
- Cytisinicline Commercialization: Achieve Life Sciences is a late-stage specialty pharmaceutical company developing cytisinicline for nicotine dependence. The company is preparing for commercial launch following FDA approval, which is expected in the first half of 2027. The company is pre-revenue as of 2026.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels5 records
Achieve Life Science product offering
Product offeringCore offering
Achieve Life Sciences is a late-stage specialty pharmaceutical company developing cytisinicline, a plant-based alkaloid that acts as a partial agonist at nicotinic acetylcholine receptors to treat nicotine dependence in adult smokers and e-cigarette users. The company's primary value is the drug candidate itself, supported by a five-trial clinical development program (ORCA-1, ORCA-2, ORCA-3, ORCA-V1, ORCA-OL) and an NDA currently pending resubmission with the FDA. Once approved, cytisinicline is intended to be prescribed by healthcare providers and dispensed through specialty pharmacies as the first new FDA-approved smoking cessation therapy in over two decades.
Product overview
Achieve Life Sciences is a late-stage specialty pharmaceutical company developing a single drug candidate, cytisinicline, for the treatment of nicotine dependence. Cytisinicline is supported by an extensive clinical development program consisting of five trials: the Phase 3 ORCA-2 and ORCA-3 trials for smoking cessation, the Phase 2b ORCA-1 dose-finding study, the Phase 2 ORCA-V1 trial for vaping cessation, and an open-label long-term safety study (ORCA-OL). The company's NDA for smoking cessation is under FDA review, and the vaping cessation indication has received Breakthrough Therapy Designation.
Differentiator
Problem solved
Functional benefit
Products and services
- Cytisinicline A plant-based alkaloid drug candidate with high binding affinity to nicotinic acetylcholine receptors, acting as a partial agonist to reduce nicotine withdrawal symptoms, cravings, and the reward/satisfaction associated with smoking and vaping. Developed for adult smoking cessation and e-cigarette cessation indications, supported by the ORCA clinical program with over 1,500 participants exposed to date.
Quantifiable outcome
- 12-week cytisinicline treatment showed 4.4 times higher odds of quitting smoking (30.3% abstinence rate vs 9.4% placebo, p<0.0001)
- +3 more outcomes
Companies that use Achieve Life Science
Customer profileSegments2 records
Ideal customer profiles2 records
Achieve Life Science technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Achieve Life Science partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core and major.
- Adare Pharma SolutionscoreU.S.-based manufacturing partner for cytisinicline drug product commercial supply. Achieve completed analytical method technology transfer to Adare's Vandalia, Ohio facility and successfully manufactured first engineering batch. This partnership addresses supply chain resilience and potential pharmaceutical import tariff concerns.
- OmnicommajorPartnership across multiple cross-functional agencies to create a data-driven commercial model designed to execute with precision, scale efficiently, and accelerate meaningful engagement for patients and providers.
Scale indicators7 records
Recent moves6 records
Expansion highlights6 records
Achieve Life Science competitors and assessment
Company assessmentMarket position
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
Achieve Life Science social profiles
Digital presenceAchieve Life Science financial estimates
Financial estimateRevenue estimate
Valuation estimate
Achieve Life Science leadership team
Management profileNumber of profiles
Profiles18 records
Achieve Life Science funding detail
Funding detailFunding overview
Funding rounds11 records
Investors20 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Achieve Life Science M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Achieve Life Science
What does Achieve Life Science do?
Achieve Life Sciences is a late-stage specialty pharmaceutical company developing cytisinicline, a plant-based alkaloid that acts as a partial agonist at nicotinic acetylcholine receptors to treat nicotine dependence in adult smokers and e-cigarette users. The company's primary value is the drug candidate itself, supported by a five-trial clinical development program (ORCA-1, ORCA-2, ORCA-3, ORCA-V1, ORCA-OL) and an NDA currently pending resubmission with the FDA. Once approved, cytisinicline is intended to be prescribed by healthcare providers and dispensed through specialty pharmacies as the first new FDA-approved smoking cessation therapy in over two decades.
Is Achieve Life Science a public or private company?
Achieve Life Science is a public company. It is classified as public and is currently operating.
When was Achieve Life Science founded?
Achieve Life Science was founded in 1991. It employs 11 to 50 people.
Where is Achieve Life Science based?
Achieve Life Science is headquartered in Mill Valley, United States, in the North America region.
How does Achieve Life Science make money?
One revenue line is on record: cytisinicline Commercialization.
Does Achieve Life Science have an API?
No public API is recorded for Achieve Life Science.
What industry is Achieve Life Science in?
Achieve Life Science's product category is Smoking Cessation Pharmaceuticals. Its primary akta.pro industry code is HLAIACAC, Neurology & CNS Specialty Pharmaceuticals, with a secondary code of HLAIALAH, Regulatory Strategy & IND/NDA/BLA Submissions Support. Its NAICS code is 325412 and its SIC code is 2834.