Organization (Industry)
Lupin Pharmaceuticals (United States)
ClinicalTrials.gov lists Lupin Pharmaceuticals (United States) as lead sponsor of 18 trials. It has 5 active development programs and 6 approved assets.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 1 registered with a 2026 start date. The dashed outline is the pace from the 1 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 1.2 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Lupin Pharmaceuticals (United States): 18 lead-sponsored trials and 2 legal-entity registrations.
Disease areas (7)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Myotonic Dystrophy | 6 |
| Breast Neoplasms | 1 |
| HIV Infections | 1 |
| Hepatitis B | 1 |
| Myotonia | 1 |
Showing 5 of 7 disease areas.
Trials by start year as sponsor or collaborator (10)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2026 (partial year) | 1 |
| 2025 | 4 |
| 2021 | 4 |
| 2020 | 3 |
| 2018 | 1 |
| 2017 | 1 |
| 2016 | 1 |
| 2014 | 1 |
| 2010 | 1 |
| 2008 | 3 |
Recruitment duration, a model prediction: 3 trials still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (5)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Mexiletine granules for prolonged-release oral suspension | Myotonic Dystrophy | Phase 3 | 2 |
| Oral Capsule Mexiletine (IR) | Myotonia | Phase 3 | 1 |
| Granular powder in unit dose foil-lined sachet Mexiletine (PR) | Myotonia | Phase 3 | 1 |
| Mexiletine | Myotonic Dystrophy | Phase 3 | 2 |
| Mexiletine 167 mg | Myotonic Dystrophy | Phase 3 | 1 |
Approved assets (6)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Lupin's Pegfilgrastim | 1 |
| PEGFILGRASTIM | 1 |
| Mexiletine | 4 |
| ProAir HFA | 1 |
| Methacholine | 1 |
Showing 5 of 6 approved assets.
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 33% hit target (n=6) | 17% on time (n=6) |
Journals published in (3)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| BJOG : an international journal of obstetrics and gynaecology | 1 |
| European journal of obstetrics, gynecology, and reproductive biology | 1 |
| The New England journal of medicine | 1 |
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 157 | 27 | 2025-11-25 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| VAI | 4 |
FDA recalls (122)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01 | Class II | 2026-06-23 |
| prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA | Class II | 2026-06-04 |
| Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03. | Class II | 2026-04-24 |
| Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01 | Class II | 2025-11-13 |
| Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09. | Class II | 2025-11-05 |
Showing 5 of 122 recalls.
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 9 | 2025-02-07 |
Organization relationships (17)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Lupin Atlantis Holdings S.A. | Co sponsors trial with | 3 |
| Cipla (India) | Co sponsors trial with | 1 |
| Alvogen (South Korea) | Co sponsors trial with | 1 |
| Janssen Scientific Affairs (United States) | Co sponsors trial with | 1 |
| Merck & Co., Inc., Rahway, NJ, USA (United States) | Co sponsors trial with | 1 |
Showing 5 of 17 relationships.
Latest dated events (313)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-08-03 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-06-23 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-06-04 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-04-24 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-11-25 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 313 events.
Biomarker capability evidence (38)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| EPO | Trial sponsor | Named in trial inclusion criteria |
| KRAS | Trial sponsor | Named in trial inclusion criteria |
| NRAS | Trial sponsor | Named in trial inclusion criteria |
| PIP | Trial sponsor | Named in trial inclusion criteria |
| APOH | Trial sponsor | Named in trial exclusion criteria |
Showing 5 of 38 evidence rows.
On Scientist.com
Lupin Pharmaceuticals (United States) is listed as a research supplier in the Scientist.com network.
Service areas
Lupin Pharmaceuticals offers API synthesis, fermentation products, and manufacturing services.
- Website
- www.lupinpharmaceuticals.com
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, manufacturing and distribution sites, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.
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