Pulmonary fibrosis (PF) can lead to respiratory distress, persistent dry cough, and a decline in quality of life, and may be life-threatening in severe cases. The aim is to mine and analyze drug-related PF signals, summarize potential risk medications, and provide references for clinical medication safety. This research accessed data from the US Food and Drug Administration Adverse Event Reporting System covering reports from January 2004 to September 2024. Proportional disproportionality methods were utilized to explore the relationship between drugs and PF, and to assess demographic information, drug-related PF risks, and the timing of PF onset. The Food and Drug Administration Adverse Event Reporting System database contained reports of 830 drugs associated with PF. Through disproportionality analysis and subsequent filtering, 33 drugs were identified as having significant risks. Fifteen antitumor and immunomodulatory drugs (45.45%) were noted, including bleomycin (reporting odds ratio [ROR] = 41.68), interferon gamma-1B (ROR = 12.11), and anagrelide (ROR = 6.63). Four cardiovascular system drugs (12.12%) included amiodarone (ROR = 41.92), dronedarone (ROR = 10.25), and simvastatin (ROR = 6.94). Four respiratory system drugs (12.12%) included indacaterol (ROR = 6.87), salmeterol/fluticasone (ROR = 4.30), and olodaterol (ROR = 3.76). Four antipathogenic microbial drugs (12.12%) included nitrofurantoin (ROR = 22.92), sulfasalazine (ROR = 5.69), and hydroxychloroquine (ROR = 3.51). Six other drugs (18.18%) included iodine-131 (ROR = 19.72), calcium carbonate (ROR = 8.59), and tamsulosin (ROR = 7.48). Amiodarone (Bayesian confidence propagation neural network [BCPNN] = 5.26), bleomycin (BCPNN = 4.95), and nitrofurantoin (BCPNN = 4.40) were the 3 drugs characterized by the greatest associated PF risk. The time to PF onset from antitumor and immunomodulatory drugs was significantly shorter than that from other drug types ( P = .0082). The study identified 33 drugs showing disproportionality signals suggestive of potential associations with PF, most notably among antitumor and immunomodulatory agents, which exhibited a significantly shorter time to PF onset compared with other drug classes. The 3 drugs associated with the greatest PF risk were amiodarone, bleomycin, and nitrofurantoin. These findings highlight potential pharmacovigilance signals that warrant clinical vigilance and further validation through prospective studies.

25 May 2026·Journal of neurosurgery. Case lessons

Recurrent multilevel postoperative spinal epidural hematoma in a patient with essential thrombocythemia: failure of repeated decompression and hematological correction. Illustrative case

Article

Author: Lai, Jen-Chieh

BACKGROUND:

Postoperative spinal epidural hematoma (SEH) is an uncommon but serious complication after lumbar endoscopic surgery, with an incidence of 0.1%–0.2%. Although percutaneous endoscopic lumbar discectomy (PELD) minimizes tissue disruption, SEH may still occur, particularly in patients with hematological disorders. Essential thrombocythemia (ET) presents a hemostatic paradox of simultaneous bleeding tendency and hypercoagulability, increasing postoperative hematoma risk. Massive multilevel SEH after PELD is rare.

OBSERVATIONS:

A patient developed severe left leg pain immediately after PELD. A second endoscopic reexploration was performed without MRI, removing clotted blood, but symptoms rapidly recurred, prompting open decompression at L2–4. MRI performed afterward revealed a massive posterior epidural hematoma from L1 to S1, similar to previously reported multilevel SEHs. Rapid hematoma reaccumulation was attributed to uncontrolled ET following discontinuation of cytoreductive therapy. Neurological symptoms stabilized only after the resumption of hydroxyurea and anagrelide, with MRI showing near-complete resolution.

LESSONS:

This case illustrates the hemostatic paradox of ET in spine surgery, in which excessive bleeding and rapid clot formation coexist. When hematological instability drives SEH, repeated decompression may fail, and hematological correction becomes essential. Surgeons should recognize the limitations of endoscopic hemostasis and consider early hematological optimization when postoperative symptoms recur.https://thejns-org.libproxy1.nus.edu.sg/doi/10.3171/CASE25962

01 Jan 2026·[Rinsho ketsueki] The Japanese journal of clinical hematology

[Gastric intramural hematoma during treatment with aspirin and anagrelide in a patient with essential thrombocythemia].

Article

Author: Umakoshi, Akihiro ; Nakamura, Masahisa ; Rikitake, Junpei ; Nakai, Ritsuko ; Takagi, Atsuhiro ; Mukai, Satoru ; Hatanaka, Kazuo

A 62-year-old man was diagnosed with JAK2 mutation positive essential thrombocythemia (ET) after developing cerebral infarction. He was treated with anagrelide and aspirin, with anagrelide increased to 5.5 mg/day, but platelet count remained around 700,000/µl. In July 2024, he presented to the emergency department with abdominal pain and vomiting. CT angiography showed a large gastric intramural hematoma as well as pseudoaneurysm from the right gastroepiploic artery. Following transcatheter arterial embolization, his symptoms improved, the hematoma decreased in size, and his condition stabilized. Gastric intramural hematoma is an extremely rare condition, often secondary to factors like anticoagulant therapy. Reports of cases diagnosed after resection of a suspected tumor highlight the importance of accurate diagnosis. Although thrombosis prevention is crucial in ET, anagrelide is associated with a higher risk of bleeding events than other therapies. To our knowledge, this is the first reported case of gastric intramural hematoma associated with ET and anagrelide.

News (Medical) associated with Anagrelide Hydrochloride

09 Sep 2026

·www.biospace.com

PharmaEssentia to Present at the Society of Hematologic Oncology (SOHO) 2026 Annual Meeting

Presentations highlight two-year Phase 3 data and real-world evidence for BESREMi® (ropeginterferon alfa-2b) in essential thrombocythemia (ET) BESREMi was recently FDA-approved for the treatment of adults with ET, regardless of genotype or disease status BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced two poster presentations at the 2026 Society of Hematologic Oncology (SOHO) Annual Meeting, which will be held September 9-12 in Houston, Texas. PharmaEssentia will present two-year results from the Phase 3 SURPASS-ET study (NCT04285086) and its ongoing extension in adults with high-risk essential thrombocythemia (ET) who were resistant to or intolerant of hydroxyurea. In the extension, it was observed that study participants who continued BESREMi ® (ropeginterferon alfa-2b-njft) maintained modified ELN response rates and platelet and white blood cell control through two years, with continued reduction in JAK2V617F variant allele burden and a safety pro with prior reports. Patients followed in the extension study who transitioned from anagrelide to BESREMi after the 52-week core study showed improved hematologic control and reduced JAK2V617F allele burden relative to their prior anagrelide therapy. Long-term efficacy and safety analyses are ongoing. Two-year results were presented in part as an oral presentation at the European Hematology Association (EHA) 2026 Congress. Additionally, PharmaEssentia will present real-world evidence from a retrospective cohort study of 55 patients with ET evaluating the use of BESREMi in community oncology settings. The analysis found that BESREMi was most commonly initiated after first-line therapy, while first-line use was also observed, predominantly in younger patients. Platelet counts and response rates trended toward optimal levels regardless of prior cytoreductive therapy history. Poster Presentation Details Title: Efficacy and Molecular Dynamics of Ropeginterferon Alfa-2b in High-risk Essential Thrombocythemia: Two-year Results from the Phase 3 SURPASS-ET Trial Abstract Number: 944 Poster Number: MPN-944 Presenter: Dr. Lucia Masarova, University of Texas MD Anderson Cancer Center Date: 9/9/26 Time: 6:25-7:55 PM Title: Real-world Patient Characteristics, Treatment Patterns and Blood Counts of Patients with Essential Thrombocythemia Treated with Ropeginterferon Alfa-2b in the US Community Oncology Setting Abstract Number: 1090 Poster Number: MPN-1090 Presenter: Dr. Solly Chedid, Singing River Cancer Center Date: 9/9/26 Time: 6:25-7:55 PM About PharmaEssentia PharmaEssentia USA Corporation, located in Burlington, Massachusetts, is a subsidiary of PharmaEssentia Corporation (TWSE: 6446). PharmaEssentia Corporation, headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung, Taiwan. For more information about PharmaEssentia USA, visit the website , LinkedIn or X (formerly Twitter) . About Essential Thrombocythemia (ET) Essential thrombocythemia (ET) is a rare blood disorder and type of myeloproliferative neoplasm (MPN). It is characterized by the bone marrow overproducing platelets. Patients with ET are at an increased risk of blood clots, abnormal bleeding and enlarged spleens. ET is often caused by genetic mutations such as a JAK2 genetic mutation. About BESREMi® (ropeginterferon alfa-2b-njft) Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi® for the treatment of adults with polycythemia vera (PV) and essential thrombocythemia (ET). BESREMi® holds orphan drug designation in the United States for the treatment of polycythemia vera and essential thrombocythemia in adults. The product was developed by PharmaEssentia. PharmaEssentia retains full global intellectual property rights across all indications. INDICATION BESREMi® is indicated for the treatment of adults with polycythemia vera and for the treatment of adults with essential thrombocythemia. IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS DISORDERS Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw therapy with persistently severe or worsening signs or symptoms of the above disorders. CONTRAINDICATIONS Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation or suicide attempt Hypersensitivity to interferons or to any of the inactive ingredients in BESREMi Hepatic impairment (Child-Pugh B or C) History or presence of active serious or untreated autoimmune disease Immunosuppressed transplant recipients WARNINGS AND PRECAUTIONS Depression and Suicide: Monitor for symptoms and need for treatment. Endocrine Toxicity: Discontinue if endocrine disorders occur that cannot be medically managed. Cardiovascular Toxicity: Avoid use in patients with severe or unstable cardiovascular disease. Monitor patients with history of cardiovascular disorders more frequently. Hematologic and Hemorrhagic Disorders: Perform blood counts at baseline, every 2 weeks during titration, and at least every 3-6 months during maintenance treatment. Hypersensitivity Reactions: Stop treatment and immediately manage reaction. Pancreatitis: Consider discontinuation if confirmed pancreatitis. Colitis: Discontinue if signs or symptoms of colitis. Pulmonary Toxicity: Discontinue if pulmonary infiltrates or pulmonary function impairment. Ophthalmologic Toxicity: Monitor for ocular toxicity. Promptly evaluate eye symptoms and discontinue if new or worsening eye disorders. Hyperlipidemia: Monitor serum triglycerides before BESREMi treatment and intermittently during therapy and manage when elevated. Hepatotoxicity: Monitor liver enzymes and hepatic function at baseline and during treatment. Reduce dose or discontinue depending on severity. Renal Toxicity: Monitor serum creatinine at baseline and during therapy. Discontinue if severe renal impairment develops. Dental and Periodontal Toxicity: Advise on good oral hygiene and regular dental examinations. Dermatologic Toxicity: Consider discontinuing if clinically significant dermatologic toxicity. Driving and Operating Machinery: Advise patients to avoid driving or using machinery if they experience dizziness, somnolence, or hallucination. Embryo-Fetal Toxicity: Can cause fetal harm. Please see full Prescribing Information , including Boxed Warning. Contacts Media Contact Muriel Huang Director, Investor Relations and Corporate Communication muriel_huang@pharmaessentia.com

Clinical ResultDrug ApprovalPhase 3Orphan DrugASH

02 Sep 2026

·www.fiercepharma.com

On the 'cusp,' PharmaEssentia gains FDA label expansion for Besremi

These are heady days for PharmaEssentia, a biotech that got its start 23 years ago in Taiwan, went public 10 years later and now is deepening the foothold of its first commercial product Besremi. “There’s a lot of electricity in the air in the organization right now,” Samuel Lin, PharmaEssentia’s Head of U.S. Global Operations, said in an interview with Fierce. “Sometimes you have to stop and pinch yourself a little bit.” The excitement ramped up on Monday as the FDA signed off on a key label expansion for Besremi, endorsing it as a treatment for the rare bone marrow disorder essential thrombocythemia (ET). The label specifically covers adults with ET regardless of their genotype or disease status, including newly diagnosed patients who haven't received cytoreductive therapy, according to an Aug. 31 release . Besremi now becomes the first new product approved in the indication since 1997 and gets PharmaEssentia one step closer to achieving its goal of going “full spectrum,” as Lin put it, to become the world’s first drugmaker to gain clearance to treat all four bone marrow cancers, also referred to as myeloproliferative neoplasms (MPNs). The other bone marrow disorders are myelofibrosis, chronic myelogenous leukemia (CML) and polycythemia vera (PV), the latter of which Besremi was cleared to treat in 2021. Making waves in MPN is particularly satisfying for PharmaEssentia, which is swimming in the deep end of the industry pool, competing with powerhouse companies Takeda, Merck, Novartis and Incyte. “What we’ve seen is proof positive. There’s interest from larger players,” Lin said. “It affirms what we already know—MPN is an opportunity to serve a broad cohort of patients and it’s a really robust opportunity.” As a monopegylated, long-acting interferon, Besremi works by binding to transmembrane interferon alpha receptors (IFNAR) to activate the JAK-STAT signaling pathway, which triggers anti-proliferative, pro-apoptotic and immunomodulatory effects. The first-in-class treatment, which is injected every two to four weeks, combats ET by modulating the overproduction of platelets. Too many platelets can lead to blood clots, abnormal bleeding, stroke and organ damage. With PV, Besremi curbs the overproduction of red blood cells. PharmaEssentia’s ET nod was backed by data from two trials, including the phase 3 Surpass-ET study, which evaluated Besremi against Takeda’s Agrylin, the last drug approved in the indication some 29 years ago. In the trial, which included high-risk ET patients who were resistant to the chemotherapy hydroxyurea, Besremi had a significantly higher response rate at 43% versus 6% for Agrylin at months 9 and 12. The secondary endpoint, which examined reductions in JAK2 V617F allelic burden, was also met, suggesting that Besremi may have a greater effect on underlying disease pathology than the comparator drug, PharmaEssentia explained. The ET indication adds a patient population of about 148,000 in the U.S, compared to the roughly 6,200 who are affected annually by PV, according to the company. “We’ve learned a lot with the launch of Besremi in PV,” Lin said. “And with ET, ultimately, it’s the same treatment mix and a lot of the areas where the business is driven—both from the physician side and also the patient side—there’s enough overlap, so we’re confident.” Incyte and Novartis’ JAK inhibitor Jakafi—which has been on the market for more than a decade for PV and myelofibrosis—is the top-selling drug in the MPN space, accounting for sales of $3.1 billion last year. Also on its way to the market is Takeda and Protagonist’s once-weekly injectable hepcidin mimetic peptide rusfertide, which won an FDA nod for PV on Friday. The drug will now carry the brand name Mimrylo. Meanwhile, as a treatment for PV and ET, Merck is investigating oral lysine-specific demethylase 1 (LSD1) inhibitor bomedemstat, which it acquired in its $1.4 billion buyout of Imago BioSciences in 2022. With Besremi its lone commercial product, PharmaEssentia reported revenue of $15.63 billion new Taiwan dollars ($494 million) last year, which was up 61% from 2024. With sales continuing to track upward, Lin said that Besremi has an outside chance of reaching the $1 billion revenue mark this year. “I think we’re a company on the cusp. We’re just a couple different adjustments away from really Besremi entering its blockbuster era,” Lin said, adding, "I do firmly believe we should be on a lot of people’s radar because we are making an impact.” The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalClinical ResultImmunotherapy

02 Sep 2026

·firstwordpharma.com

FDA adds essential thrombocythemia to Besremi's label

PharmaEssentia's Besremi (ropeginterferon alfa-2b-njft) notched its second FDA approval on Monday, winning a green light in essential thrombocythemia (ET). The long-acting interferon therapy was first approved by the US agency in 2021 for polycythemia vera. Specifically, Besremi was cleared to treat adults with ET, regardless of their genotype or disease status, including newly diagnosed patients who are naive to cytoreductive therapy. According to PharmaEssentia, Besremi is the first new treatment available to US patients with ET in nearly three decades. Patients with the rare blood cancer, which is caused by an overproduction of platelets, have a high risk for heart attacks, strokes and pulmonary embolism.The approval was based on the Phase III SURPASS-ET trial, which randomised 174 patients with ET to receive either Besremi or platelet-lowering medicine anagrelide.Besremi met its primary endpoint, achieving a 42.9% response rate — as per modified European Leukemia Net response criteria — versus a 6% rate for anagrelide.At last year's American Society of Clinical Oncology (ASCO) meeting, PharmaEssentia reported that the long-acting interferon also demonstrated improvements on four key measures compared with anagrelide: normalised platelet and white blood cell counts (56.0% vs 6.0%), splenomegaly improvement/stabilisation (87.9% vs 54.2%), symptom control (71.4% vs 33.7%) and fewer haemorrhagic/thrombotic events (84.6% vs 51.8%).In regards to safety, Besremi had a more tolerable profile than anagrelide, with fewer treatment-related serious adverse events (AEs) than its comparator (2.2% vs 10%). PharmaEssentia's drug also led to fewer AE-related discontinuations (5.5% vs 18.8%), ET-related thrombotic events (1.1% vs 8.8%) and cardiovascular events (0% vs 7.5%).

Clinical ResultDrug ApprovalPhase 3ASCO

100 Deals associated with Anagrelide Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D07455 D10255	Anagrelide Hydrochloride	L01XX35	DB00261

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Thrombocythemia, Essential	European Union	Takeda Pharmaceuticals International AG	15 Nov 2004
Thrombocythemia, Essential	Iceland	Takeda Pharmaceuticals International AG	15 Nov 2004
Thrombocythemia, Essential	Liechtenstein	Takeda Pharmaceuticals International AG	15 Nov 2004
Thrombocythemia, Essential	Norway	Takeda Pharmaceuticals International AG	15 Nov 2004
Thrombocytosis	United States	Takeda Pharmaceuticals U.S.A., Inc.	14 Mar 1997

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	NDA/BLA	Canada	Septa Pharmaceuticals, Inc.	01 Jan 2026

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2026	Not Applicable	Myeloproliferative Disorders	347	Interferon	biekvamjhw(sfrixmffaq) = OS & progression-free survival (PFS) did not differ by MPN subtype. ydjsavtrrr (yahmhvwqxh ) View more	Positive	12 May 2026
EHA2026	Not Applicable	Myeloproliferative Disorders	347	Ruxolitinib		Positive	12 May 2026
EHA2026	Not Applicable	Thrombocythemia, Essential	60	hydroxyurea (HU)	bfvcvpempz(wcawwxlmks) = twnokkbvue txaraotgwz (bjeamxpwov ) View more	Positive	12 May 2026
SURPASS-ET (EHA2025)	Phase 3	Thrombocythemia, Essential Second line	174	Ropeginterferon alfa-2b	qtthkmqezw(sfvsjsxhsw) = wafdndmqzi sfbymltqbx (gnajsqyzxx ) View more	Positive	14 May 2025
SURPASS-ET (EHA2025)	Phase 3	Thrombocythemia, Essential Second line	174	Anagrelide	qtthkmqezw(sfvsjsxhsw) = xuvlpqpdai sfbymltqbx (gnajsqyzxx ) View more	Positive	14 May 2025
NCT03866434 (CTgov)	Phase 1	-	20	Omeprazole+SPD422	tatkyaoeof = xtdhlrvlxe usxvuebrkp (fpvfwzqqcp, cthqbucxlk - mhesrdqmvn) View more	-	24 Apr 2020
EHA2019	Not Applicable	First line	53	Anagrelide	iuuztblljh(jluirrdycp) = oxpuqxrxww cjcdxridlj (wslxndxawz ) View more	-	16 May 2019
NCT01467661 (Pubmed \| Int J Hematol) Manual	Phase 3	Thrombocythemia, Essential	53	anagrelide	squohbnwad(zlditegvoq) = 1088.3 × 10^9/L to 473.5 × 10^9/L pplcsedduv (pitbacitgx )	Positive	01 Nov 2018
NCT00202644 (CTgov)	Phase 4	Thrombocythemia, Essential	150	Anagrelide (Anagrelide)	vsijadpeox(lokhnepnpk) = mtajabxhwa vobjrfdgvl (xjruerohtq, 4.81) View more	-	24 Jan 2018
NCT00202644 (CTgov)	Phase 4	Thrombocythemia, Essential	150	Hydroxyurea (Hydroxyurea)	vsijadpeox(lokhnepnpk) = zttedxnzrg vobjrfdgvl (xjruerohtq, 4.59) View more	-	24 Jan 2018
NCT01467661 (CTgov)	Phase 3	Thrombocythemia, Essential	41	SPD422	lcqhlspwcs(cbchgyvtky) = jwcqbvorql kjrjijtjxs (lrlmceeeuu, 433.14) View more	-	08 Jun 2016
EHA2015	Phase 2	Myeloproliferative Disorders \| Thrombocytosis	18	Anagrelide CR	kscuwwwegi(pfmlxydxsc) = vafedgzspx uftktgncbz (tikxtfngyr )	-	21 May 2015
Pubmed \| Int J Hematol	Phase 3	Thrombocythemia, Essential Second line	53	Anagrelide	wmmpvdlzzq(cqtlfyzkqj) = mfelseyvmn xnqlqdsigj (ppnupuizdu ) View more	-	01 Oct 2014

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